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COMPARATIVE STUDY OF A HANDS FREE CRUTCH IN EL SALVADOR KELLY FALLON A thesis submitted to the School of Rehabilitation Therapy O in confonniiy with the requirements for the degree of Master of Science Queenrs University Kingston, Ontario, Canada September 200 1 Copyright 0 Kelly Fallon, 200 1
Transcript of HANDS FREE CRUTCH IN EL KELLY - Library and Archives Canada · 2004. 9. 1. · using standard...
COMPARATIVE STUDY OF A
HANDS FREE CRUTCH IN EL SALVADOR
KELLY FALLON
A thesis submitted to the School of Rehabilitation Therapy
O in confonniiy with the requirements for
the degree of Master of Science
Queenrs University
Kingston, Ontario, Canada
September 200 1
Copyright 0 Kelly Fallon, 200 1
Bblioth ue nationale % du Cana
The arithor has gmted a non- L'auteur a accordé une licence non exclusive licence aliowing the exclusive pezmettmt & la Natiod Library of Canada to Bibliothèqne nationale du Canada de reproduce, loan, disûibute or seII reprodime, prêter, distriilmer ou copies of this thesis in microfonn, vendre des copies de cette thèse sous paper or electronic formrits. Ia forme de microfiche/nIm, de
reproduction sm papier on sin format 61ectmnique.
The author retaÏns ownership of the L'auîetr conserve la propriété du copyright in this thesis. Neither the droit d'auteur qui protège cette thèse. thesis nor snbstantial exfracts iiom it Ni la thèse ni des extraits substantiek may be printed or otherwise de celle-ci ne doivent être imprimés reproduced without the aufhm's ou autrement reproduits sans son permiSSi011, morisation,
= -- - ARSTIhAeT
The Hands-Free Cmtch (HFC) was developed in Canada as an alternative to
standard axillary crutches (ACs). ACs are restrictive to the han& and can cause many
secondary complications of the upper extremities. In developing countries ACs are often
the ody alternatives to pmstheses. The primary purpose of this study was to evaluate the
effectiveness and acceptability of the HFC when compared to ACs in El Salvador. Using
a crossover design, 22 subjects with either a foot or ankle fracture or a ~ s - t i b i a l
amputation completed a IO-day trial of HFC and a IO-day trial of ACs. A cuiturally
sensitive &item questionnaire and 9-item functional test were administered following
each trial period. Items on the questionnaire were both open and closed ended and
examined device usage, difficulty, satisfaction, rasons for usehon-use, falls, and overall
device preference. R d t s indicated higher satisfaction ratings of the HFC in t e m of
device cornfort e.00). Subjects also scored higher with HFC use on 3 items on the
functional test: ca-g a mal1 object p.00); opening/walking rhrough a doorway
@=.04); and balancing with one arm overhead (p.03). One item was scored higher with
AC use: stepping uplover a curb ( ~ ~ 0 3 ) . Overall preference was for the use of ACs with
IS subjects preferring the AC and 7 subjects preferrhg the HFC. B was also found that
subjects chose to use the HFC for signincantly fewer days @=.00) than the ACs for both
indoor and outdoor use. Recommended improvements to the HFC design included adding
a h g e to the beam, Uicreasing the surface area of the foot piece, and shortening the tibia1
tray for amputees. The potentid for fbture applications of the HFC in the developing
world as a cost-effective and fûnctional device is supporteci by this shidy.
- - - - - -A€KNOWLE"EMENTS-
1 am extremely grateful to the many people who have made this research possible.
Thaak you to my thesis supervisor, Dr. Will Boyce, whose guidance, encouragement, and
contniution to my understanding of the research pmcess has been significant. Thank you
to my advisory committee, Dr. Sandra Olney and Dr. Wendy Pentland, for their insighthil
feedback and advice regardhg cross-cultural research.
Th& to CDA, for providllig me with the necessary financial resources to conduct
this research and to CanadaLeg, Inc for donating the HFC devices. To the Central
Amenca Land Mine Survivors project (CALMS), Kingston, ON and the University of
Don Bosco (UDB), El Salvador, thank you for providing me with the necessary contacts
and support systems in El Salvador. in pdcular, th& to Heinz Trebbin, coordinator
of the prosthetics and orthotics program at UDB, who was a great help throughout my
stay in El Salvador. Thanks to my translater, Karina, who becarne a great niend and my
lifeline in more than one 'cultural' situation. Many thanks to the participating hospitals
subjects who agreed to devote many week of their time to this mearch. The support and
enthusiasm 1 received fiom this group was invaluable.
A £inal thanks to Chrîs and my family for their unrelenting encouragement and
support in this endeavor h m start to finish.
CEAITER 1. INTRODUCTION ................................................................................ ...l
2.1 D ~ ~ O N S ............................................................................................................... 6
2-2 CONSEQUENCES OF MOBILITY IMPAIRMENT M POST CONFLICT COUNTRIES .............. 7
........................................................................... 2.3 RESEARCH S r n e : EL SALVADOR 9
2.3.1 Geographical In formation and Populaiion ....................................................... -9
2.3.2.Political Situation and Civil War ............................................................... 1 0
2.3.3 Signtjkaace of Lower Exiremity MobiIity Problems within El Sabador ......... 12
2.4 PROBLEMS WlTH AX~LLARY CRUTCHES AND APPROPRIATE TECHNOLOGY ............... 13 2.5 PROBLEMS IN ACCESSMG TECHNOLOGY AND DEVELOPING TECHNOLOGY .............. 15
2-6 EVALUATION OF PROSTHETIC AND AMBULATORY DEVICES ..................................... 17
....................... 2.6.1 Reasom for Device Assessrnent and importunce of User Input If
2.6.1.1 Within Deveioped Countries ........... .... ........................................ 1 7
................................ 2.6.1.2 Within Developing Corntries .................. .... 1 9
............................................................ 2.6.2 Device Evaluation Methodologies 2 1
............................ 2.6.2.1 Within Developed Corntries ............................... ...,.... -21
2.622 Within Developing Corntries .................................................................. 24
2.6.3 Physcal F~wt ion and Qualiry of Life in Developed Coun~tlks ...................... -25
2.6.4 Imtnrments Usedfor the Cment Shcày ....................... .................... ..... 2.5
2.7 RATIONALE FORMETHODOLOGY .............................................................................. 26
................. 3. I STUDY DESIGN .. ....................................................................................... 29
3.2 PARTICIPANTS ........................................................................................................... 29
............................................................................. 3.3 RECRUITMENT AND SAMPLE SE 30
......................................................................... 3.4 R A N D O M ~ T I O N AND PROCEDURES 32
........ 3.4.1 Lower E m e m i î y AssLÎtive Device Acceptance --A ) Questionnaire 35
3.4.2 Lower Ertremity Asshtive Device Pet$onnance (LEAD-P) Measure .............. 39
3.4.3 Coding ofMeasures .................................................................................... 41
....................................................... 3.4.4 Reliabiiity and Vaiidiîy of =-A and -P 41
3-5 A D ~ I S ~ T I O N OF ~ S U W .............................................................................. 43
3.6 DATA ANALYSIS .......................*..........*......*............................................................. 45
3.6.1 Cornpa&ons Beween the Use of Two Devices ................................................ 46
..................................... 3.6.2 Demogntphic Re&atiomhips in Device Preference 4 7
......................................................... 4.1 DEVIATIONS FROM ORIGNAL METHODOLOGY 48
...................................................... 4.7 REASONS FOR INDOOR AM) OUTDOOR NON-USE SS
48.4 F e Clse #Hm& ...................... .... ..... ......................*....... ....-...-~ 59
...................................................................................... 4.8.2 Equal Weight Bearing 5 9
............................................................. 4.8.3 Early Ambularion md Gait Training 6 0
4.8.4 Combination of the HFC and AC Use ...................................................... 60
4.9 FUNCTIONAL PERFORMANCE ............................ .. ................................................. 60
........................................................... 4.10 TRENDS RELATED TO DEVICE PREFERENCE 6 2
.................. 4.1 1 TEENDS WLATED TO SATISFACTION WITH DEVICE C~CTERISTICS 64
........................ .....*......... 4.12 USER RECOMMENDAT~ONS ..... .. 66
.............................................................. 5.1 FUNCTIONAL ABILLTIES tN USING THE HFC 68
5 . I . 1 PhysioIogicaI factors in HFC Gait ..................... .. ..................................... 69
5 . I.2 Biomechanics ofHFC Goit ............................................................................... 71
.......................................................................... 5.1.3 Comfort Reiated to Function 74
...................................................... .................... 5.1.4 Training Factors ................. 7 6
............................................. 5.2 ENVIRONMENTAL CONS- ......................... ......... 76
............................................ 5.3 CULTURAL AND SOCIAL ISSUES WITHiN EL SALVADOR 78
5.3.1 Cultur.alLy @eczÿic Ac t i v i t i e r . . . . 78
............................................................................. 5.3.2 Acceptubility of Appemance 79
........................................................................................ 5.3.3 Role of the Family -80
6.1 CONCLUSIONS ........................................................................................................... 82
62 LIMITATIONS OF THE STUDY ..................................................................................... 84
........................................................ 6.3 RECOMMENDATIONS FOR FURTHER RESEARCH 87
R E F E ~ ~ S . o ~ ~ o ~ o o o o o o o o œ ~ o o e o ~ ~ o o e ~ o œ ~ o o ~ o o o o e o o o o o o o o o e o o o œ o o o o o ~ o i o o o o e e ~ o o e e o œ o o o o o o o o o œ œ œ œ œ o œ œ e œ e ~ œ œ œ ~ œ œ ~ ~ o ~ ~
APPENDIX A. INFORMATION SEIIWT AND CONSENT FORM (ENGLIS H).... 99
APPENDIX Bo INFORMATION SEFEET AND CONSENT FORM (SPANIS EI)...IOI
APPENDKX Co LOWER EXrrREMITY ASSISTIVE DEVICE-ACCEPTANCE (LEAD-A) 104
APPENDIX Do LEAD-A (SPANISH)oeoeowooeo.oooo~oeooo*oooHooooeoooeooœoeoooooooooooooeoeeœeoooeeœoeeeoooo 1 13
APPENDIX Eo LEADPERFORMANCE (LEADOP) (ENGL1SH)-o.--121
APPENDIX F o LEAD-P (SPANIS~oooooeoooooeooœoeoœoeoeooooeooooeee~oooooooooooooœeeeoœeœœœœoœ~œ~ooœeœ 122
APPENDIX G o PARTICIPANT DEMOGRAPHICS oooooooooeeooooeoooooooooooooœeoœoœeœo.ooeoeo 123
-LW of'PaMes
TABLE 1 CONTENTS OF THE LEAD-A ................................................................................. 38
............................................... TABLE 2 MODIFICATIONS OF THE PPA LOCOMOTOR INDEX 40
..................................................................................... TABLE 3 SUBJECT DEMOGRAPHICS 50
....................................... TABLE 4 DEMOGRAPHIC CHARACCUUSTICS BETWEEN GROUPS -51
...................................................................... ................... TABLE 5 USAGE OF DEVICE .,.,, 52
TABLE 6 RATINGS OF LEVEL OF D ~ C ~ ~ L T Y BETWEEN HFC AND ACS ... .......................... 53
......................... TAEILE 7 ~?AT~NGS OF LEVEL OF SATISFACTION BETWEEN HFC AND ACS 54
TABLE 8 PERCENTAGE OF TIME SPENT WITH AMI W~THOUT DNICE ................................ 55
.............................. TABLE 9 SUBJECT REASONS FOR INDOOR NON-USE OF HFC AND ACS 56
......................... T ~ L E 10 SUBJECT REASONS FOR OUTDOOR NON-USE OF AND ACS 57
TABLE 1 1 OVERALL SCORES ON THE LEAD-P USW HFC AND ACS ................................ 62
........................................ TBLE 12 TRENDS AMONG SUBSETS AND PREFERENCE GROUPS 64
................... TBLE 13 DEMOGRAPHIC SLJBSETS M RELA~ON TO PERCEIVED INSTABILITY 65
.......... T ~ L E 14 RELATION OF FRACTURE vs . TTA TO HEAVMESS & APPEARANCE 66
H S t t P O F H G ~ S
FIGURE 1. HANDS-FREE CRUTCH (HFC) ....................................................*-............. ........... 4
The number of amputees within third world countries is around 3.5 million (Hughes,
1992). At l e s t 80% of this population cannot a o r d proper prosthetic devices
(Cummings, 1989) since any necessary repairs and replacements during the nomal Wear
and tear of the Iimb add to the initial expense of a prosthetic limb. To confound matters
m e r , the mere 2000 trained prosthetists and orthopedic technologists in the developing
world cannot meet the ovenvhelming demand for affordable devices (Hughes, 1992). To
meet a standard of one professional for every 1000 people requiring orthopedic devices,
there would need to be 20,000 trained personnel - ten times the number currently
available (Hughes, 1992).
As a result, many lower limb amputees in developing countries are restticted to
using standard axillary mutches (ACs). Aithough these cmtches are Iow in cost and
easily fabricated, the individual's arxns and han& are constantly required during
ambulation, which makes the independent completion of day-to-day tasks involving
carrying objects very difficuit Several secondary complications have been reported with
the use of d l a r y crutches. Areas of increased pressure on the upper extremity may lead
to compression of nerves and artenes as weIl as skin irritation. in addition, the energy
c o s of catch waiking is very high (Dounis, Shieperj, Morteimans, & De Roo, 1980;
Dounis, Rose, Wilson, & Steventn, 1980; Fisher & Patterson, 1 98 1).
One solution to meet some of the financial and practical needs among amputees
within developing countries is to pmduce an inexpensive alternative to standard mtches,
which does not require upper extremity support. Such an ambulatory device should be
low in cost, durable, and use momilar compomts to simpliQ repairs. The device should
- be &justable toeneble ms- pr&uetio~tane epopt~ktie ef beth gmuciag &il&= a d
adula of various heights.
In an effort to meet the requirements for such an ided alternative to standard
crutches, Mr. Lance Matthews, in conjunction with Sunnybrook Hospital in Toronto,
developed a han& fkee crutch WC). This crutch consists of four simple components: a
vertical beam with pin holes dong its length to aliow for varying user heights; a tiiial tray
on which rests the bent knee, attached to the beam by a pin; two straps above the knee
with quick release buckles to secure the thigh to the beam; and one strap below the knee
with quick release buclcies to secure the lower leg to the tibial tray (Figures L and 2).
Usen of the HFC are forced to bear weight through the knee complex including the tibial
condyles, tibial tuberosity, distal patella and, to a lesser extent, the patellar tendon. The
device is easily accomrnodated to either left or right leg use by revershg the hbid tray
and straps.
A pilot study was completed at two Canadian trauma centres among subjects with
the unilaterd ankie injuries requiring a period of non-weight bearing. When compared
with standard axillary mtches, the HFC had significantly positive results in the areas of
overall function, cornfort, and ease of use (Dalton et al., 2000 & 200 1). These promising
preliminary r d t s led the investigators to explore M e r research options, one of which
was the introduction and testing of the HFC design in El Salvador. The device was
coasidered a potential long-term solution for people with a trans-tiiial amputation ('ïT'A)
who caanot afford a standard prosthesis.
The short-term potential for HFC use was aiso considend In El Salvador, there is
o h a long fihication period h m the thne of initid prosthetic fitting to the t h e that it
is ready to be worn by the user. In the meantime, people with lower iimb amputations
- - -- ~ r e ~ m ~ ~ ~ e r u t * ThepotenWfkwHFG wewasevidenkanieag&sgmp
Another potential group to benefit k m HFC use includes those people who must rely on
ACs after lower leg injuries, such as hctures, burns, or wounds that require a penod of
non-weight bearing. If the HFC design was effective, El Salvadoran pmstheticlorthotic
technicians, with the aid of a Canadian partner organization, could investigate more cost
effective materials for their country, such as wood or thennoplastics with leather straps.
With the appropriate transfer of skills h m El Salvadoran technicians to local craftsmen,
the HFC design could be locally produced and repaired at a cost comparable to standard
ACs.
This research project was the first of three initiatives that had been planned for
investigating use of the W C within various developing countries over the next thm
years. The Central Amencan Landmine SuMvor (CALMS) project at Queen's
University and its local partner, the University of Don Bosco in El Salvador, have assisted
the researcher with this initiative. Of particular interest in this study were the cultural
acceptance and functional performance of the HFC.
Leg Strapsl buckles
Tibia1 Tray
Vertical Beam/ Foot Piece
I.IOti$ectfves ofsfacty
1. To develop measures of ambulatory device effectiveness and acceptability for use
within El Salvador.
2. To evaluate the effectiveness and acceptability of the Hands-Free Crutch (HFC)
when compared to standard axillary cmtches (ACs) within El Salvador.
3. To investigate the relationship between specific subject dernographic
characteristics and nibject preference for assistive walking devifes.
1.2 Research Questions
1. Do subjects have better functiooal performance and cultural acceptance with the
HFC versus the ACs?
2. What demographic characteristics are related to subject preference for HFC versus ACs?
1 3 Research Hypotheses
Based on the initiai pilot testhg resuits at the h ~ o Canadian trauma centres (Dalton
et al., 200 I), it was hypothesized that subjects with a da te ra l BK amputation or a lower
limb injury, who had a aia l with the HFC and a tnal with ACs, would rate the use of the
W C higher on a measure of device acceptance and achieve a significantly higher
objective score on a functionai test.
- - - - elmPTERZ, LlTERAm-mmw
2.1 Definitions
Rehabilitation technology encompasses a wide variety of assistive equipment for
persons with a disability. Assistive Technohgy has been &fined in the US 'Technology-
Related Assistance of People with Disabilities Act of 1988' as: "Any item, piece of
equiprnent, or product system, whether acquired commercially off the shelf, modifie& or
customized, that is used to increase, maintain, or improve funchonal capabilities of
individuals with disabilities" (P.L. 100-407; in Scherer, 1996).
It is important for al1 stakeholdea in the rehabilitation process to adapt technology to
local cultures and enviroaments to ensure susaiinability and reach effective outcornes.
The tenn appropriate technology is used to reflect this principle, especiaily regardhg
rehabilitative technology in developing countries. David Werner (1987) provided a
working dennition for this terni in regard to rehabilitation: "Technology is appropriate if
it helps those in greatest need gain substantially more conbol, equality, and hc t ion in
the circumstiinces in which they live, at a cost they can afford."
The successnil introduction of appropriate assistive devices, such as prosthetics and
a m h u h q ai& within a developing country+ is related to the philosophy of Community
Bared Rehabilitation (Cm): "CBR is a strategy within community development for the
rehabilitation, equalization of opportunities with social integration of al1 people with
disabilities themselves, their familes and communities and the appropriate health,
&cation vocational and social senrices. Community based rehabilitation empowers
persons with disabilities to take action to improve theu own üves, and contriiute rather
-- - - citmrQamordepkewhatwe s a w e e ~ ~ e s o t v e e ~ W ~-evaihbLe, d breby bedting
ai1 the communitf' (ILO, UNESCO, WHO, 1994).
2 3 Consequences of Mobiiity Impairment In Post Conflict Countries
The devastating effects of war have been felt in at lest 40 countries worldwide in
the past 10 years (Boyce, 2000). The prevdence of landmines within these countries has
led to thousands of deaths and injuries. In Mozambique, there are approximately 8000
amputees resulting fiom ltuidmhes, and in Cambodia, 1 out of every 240 people have an
amputation. h Angola, 10% of the population were either killed or mutilated by
landmines fÎom 1980- 1988 (Boyce & Weera, 1999). Each of these countries has had an
extended history of civil strife and war and the possibility of unexploded ordnance may
Iead to m e r increases in these numbers.
The World Heaith Organization strives to maintain a common laoguage relating to
disablement throughout the world. The consequences of war in developing countries
have been an integral stimulus for this effort. As a result, rehabilitative programs and
technology may be introduced to war tom countries with a common fiame of reference
and outcornes. The International Classincation of Functioning, Disability, and Health
(ICIDH-2) is a revision of the well established International Classification of
Impaiments, Disabilities, and Handicaps (ICIDH), which was issued by the World
HeaIth ûrganization in 1980. This revision was deemed necessary to avoid the negative
connotations of the ternis 'disabüity' and 'handicap' (WHO, 2001). The cumnt ICIDH
version has undergone field trials over the past five years and is being considered by
WHO for approval as an internationally accepted classincation nlating to disabfity
issues.
- - - - The-eksSe8fiow s y s t e r s e M ~ I G B K - 2 ~ ~ y beappkble te ths c o n x c p e a ~ ~ ~ o ~
landmines among those living in conflict and post-conflict situations. Impairment
resulting h m a landmine explosion refers to 'bproblems in body structure such as a
significant deviation or loss" including amputation, spinal cord injury, blindness, or
bums. Activities (formerly called disability in the original ICIDH) are a second
dimension that needs to be considered. An activity limitation is a bbciifficuIty an
individual may have in executing activities", such as self-care activities, work tasks, and
leisurely activities. The provision of ~habilitative technology in this type of situation is
aimed at relieving a person's hctionai limitations, such as a decrease in mobility.
Participation restrictions (formerly cailed handicaps in the original ICIDK) are 'bproblems
an individual may experience in involvement of life situations", such as physical
accessibility and social stigma In addition to these three dimensions, there are contextuai
factors (Le. environmental and personal factors) that affect an individual's disablement
expenence. Environmental factors are extrinsic to the individual, such as attitudes of
society and architechual characteristics. Personal factors include age, gender, other
health conditions, and cultural characteristics (WHO, 2001). The focus of the curent
study is on assessing individuals' impairments and activity limitations, through an
examination of the contextual factors that interact with an assistive device.
People with impairments and aaivity limitations in post-contlict situations are faced
with serious economic and social consequences. In a study examining the experience of
living with fûnctional Limitations in war-tom Guatemala, societal aninides were found to
be a primary factor contn'buting towards a difficult Me. People with these k ta t ions
were pitied, overpmtected, ignored, or forgotten. However, emerging programs in both
d e private and public sectors are begimbg the transformation towards iact.eased
.- - - - 3eLtSitivitytetbneeds antt p m b l f f l l 4 0 f i n d i v i ~ w i & b p r U w e n ~ f iznet iod
Iimiations (Couch et al., 1991). A large population of disabled soldiers adds a new
dimension of economic problerns since they represent a valuable source of untapped
labour. Re-integration of these veterans into the work force and society includes the
essential establishment of suppoa seMces such as the provision of assistive devices
(Boyce, 2000). Furthemore, war briags economic and psychologicd hardships to a11
those involved. Any additional costs that are hcurred by a disabled farnily member bnng
even greater financial and emotional stress to a family unit. Peat ( 1997) mggested that a
change in this situation m u t involve an expansion of mearch and technology transfer.
Consequently, the provision of appropriate technology, including device assessments and
skills tramfer, coupled with vocational training and increased public awareness, may
evennially lead to a morr complete integration of people with impairments and activity
limitations into society and the workplace.
2.3 Research Setting: El Salvador
2.3.1 Geographkal Information and Population
EI Salvador is the smallest country in Centrai Arnenca, less than haif the size of
Nova Scotia. Its borders include Guatemala to the West, Honduras to the north and east,
and the Pacfic Ocean to the south. The landscape of El Salvador is dominateci by
mountain ranges with many extinct, and a few active, volcanic cones. The land
throughout the country is predomÏnantly fertile, which allows coffee m p s to be grown in
the hightands, sugar in the IowIands and cotton dong the coastal plains. This fertility is
largely owed to the rainy season h m May through to the end of October, during which
time heavy dompurs occur aImost every evening. The other haIf of the year
(bhcrntretto Rprif)is hat a n d - d r p e m 9 . a r s m g b m 3008 &Mo€
(White, 1982).
There are about 5 million people in El Salvador making it the most densely
popdated country in Latin Arnerica (256.8/km2). Sixty-five percent of this population
(80% in rural areas) live in severe poverty (White, 1982). Among developing countries,
seved indicators are used to gain a perspective on the amount of poverty w i t b a
particular country. In El Salvador, the average monthly incarne per family is USâ126.
This arnount is far below the estimated %241 required per family to maintain even the
most basic lifestyle. Furthemore, half of al1 households consist of only one room for an
average of 5.6 family members. Infant mortdity is at the rate of 77 out of every 1000
infants and 73% of children d e r h m mainunition. In rural areas, 63% of the people
have no sanitary facilities, 55% have no access to potable water, and 62% have no
electricity (Montgomery, 1995).
23.2.Politicd Situation and Civil War
The history of El Salvador has been tainted by constant civil strife and war from the
time of Spanish colonial d e , when 14 elite European families maintained control over
most of the land, and continueci after national Independence was achieved in 1921.
Many indigenous cornmunities were evicted from their land and mass underemployment
and unemployment of this population created an extremely volatile group. During
attempts to reduce the social and economic injustices in El Salvador, intermittent
uprisings over the years by the poor majority have fkquently ended in severe lepression
by the upper classes (Montgomery, 1995).
Refonnpmgramsirrtk tWsd(ee~eperioee6~)a~vepoli~~& b u ~ k
ongoing injustices were only briefly masked During this period, the middle class
Christian Democratic Party (PDC) and a right-wing governmental organization called the
Nationalist Democratic Organization (ORDEN) emerged A senes of public protests and
strikes due to increased land evictions, poverty, and unemployment, in addition to the
problem of overpopdation were suppressed by ORDEN troupes. These uprisings
culrninated in 1979 when the infamous civil war began Soon after the start of the war,
the elite group of landowners formed the Nationalist Republican Alliance (ARENA).
ARENA pressured the PDC to fight agah t the emerging guerrilla movement, which
became hown as the Farabundo Marti Front for National Liberation (FMLM). These
t h e gmups, ARENA with the military, the PDC, and the F U , fought against each
other for twelve long years, resulting in the unfortunate deaths of over
75 000 people (Montgomery, 1995).
On January 16, 1992, the Salvadoran Peace Accords were signed and the National
Commission for the Consolidation of Peace (COPAZ) was installed The accords sought
to end the armed confiict, promote dernocratization by guaranteeing respect for human
ri@ and ~stnicturing s o c i e ~ (El Salvador, 1993). Part of these accords included a
section on the reintegration of former combatants. Pmgrarns were to be established for
former guerrillas and soldiers and wounded civilians and included credit for midl
businesses and f m , scholarships for schooling, and vocational training. By May 1993,
the govenunent had initiated programs that afZected less îhan 11,000 people. However,
the totaI nurnber of former combatants was at Ieast 42,000. The Iack of necessary
programs, in addition to the social stigma attacheci to the womded and disabled, meant
that tht re&egdtm of &sable& eembatanks k a m e a b w ctmong p-
coordinators (Montgomery, 1 995).
A United Nations (UN) agency called the UN Observers in El Salvador (ONUSAL)
were niccessnil in coordinating the de-mining effort throughout the country. Nearly al1
of the original 20,000 mines have been removed h m El Salvador and they are no longer
considered a sipificant safety threat. Cumntly, the defense ministry is mponsible for
any m e t removal of landmines, which are primarily situated along the border of
Honduras. Despite this large-scale effort, there is still a concem for unexploded
ordinance and landmines used for revenge attacks. (Boyce, Draft Mission Report for
CIDA, 1999, unpublished).
2 3 3 Significance of Lower Extremity Mobiüty Problems within El
Salvador
In the aftermath of a war, providing prosthetics and ambulatory aids is a challenge
due to the Iack of niacient supplies, economic challenges, and overwhelming need
(Cummings, 1996). ui 1992, the population of lower extrernity amputees in El Salvador
was estimated to be 11,359 (PAHOMrHO, 1997). This number is comprised mostiy of
the 7,000 civilians and 2,800 veteram with lower extremity amputees following the
twelve-year war (Boyce, Draft Mission Report for CIDA, 1999, unpublished). Most of
these amputations are due to land mines and other trauma such as grm shot womds.
Additionally, El Salvador had three major eatthquakes, one in 1985 and two in
2001. These MW occurrences, along with thousands of devastating aftershocks felt
throughoat the country, have d t e d m a M e r increase in the namber of Iowa
extremity amputations and b . e s (Mordes, 2001). Although this study had been
--- - --- eempktebbythetimeof theoeeumneeoWm~eea&qUlikesin 2W&, boegoing d
for &orclable prosthetics and ambulatory aids is evident.
2.4 Problems with Axlllary Crutches and Appropriate Technology
The use of axillary crutches has been dated back to 2830 BC when drawings of
people with amputations using crutches were made in Egyptian tombs (Classic, 1972).
Since that tirne, the axillary crutch has becorne the most widely used assistive device for
individuals with limited lower limb weight bearing.
Despite their long history, axillary crutches are often used merely because there are
no other satisfactory alternatives. in addition to requiring a constant use of users' hands,
thereby limiting function, there are several secondary complications. These
complications include nerve paisy (Raikin & Froimson, 1997; Shabas & Scheiber, l986),
axillary artery injuries (Abbon & Darling, 1973; Ettien, 1980, Feldman et a[., 1995; Tripp
& Cook, 1998), arterial embolism (Danese et al., 1969), skin irritation (Kang et al.,
1999), carpal tunnel syndrome (Kelher et al., L986), and reflex sympathetic dystrophy
(Declerck et al., 1993).
In nsponse to these problems, there have been several alternative devices designed
to meet the fhctional needs of persons with limited Iower extremity weight bearing.
Most of these alternatives provide either decreased energy costs or upper extremity
fkedorn (Annesley et al., 1990; Basford et al., 1990; Andrews et ai., 1994; Gillespie et
ai., 1983; Dounis et al., 1980; Stdlard et al., 1978; Di Tomasso et al., 1975; Tyson, 1974;
DeVoretz et al., 1968). A few devices cioseIy resembie the theory behind the Hands-Free
crutch in which the hihial tuberosity and pateiIar tendon are used to support full body
weight durhg ambdation (Dalton et al., 2000). Wooden peg legs have been used for
L - -- d ~ & k ~ ~ b ~ * ~ * e o n h a e a i n s d u e t o
polio (Weston, 1986). Reid (1986) developed the orthopedic scooter, which can be
propelled forward on flat surfaces by resting the bent lmee on what resembles a chair with
wheels. When compared to elbow and axillary crutches, the orthopedic scooter was
found to require less energy consumption by the user (Roberts & Cames, 1990).
Similarly, a prosthesis accommodating a knee flexion contracture has been used among
individuals with trans-tibia1 amputations (Penne11 & Mayfield, 1973).
Over the past 20 years, there have been attempts to design devices that are deemed
appmpnate to specific cultures and environments (Werner, 1987; Baneji & Baneji,
1986; Kijkusol, 1986; De Rugter & Lelieveld, 1985). Vos and colleagues (1993) outline
specific design criteria in order to assure sustainability within a third-world counm low
capital investment and manufacturing cost, unsophisticated manufacturing techniques,
easily obtainable components, comfiort and safety, durability, ergonomically sound and
esthetically attractive. The limitation of any device designed in a developing country is
that it m a y only be nrited to limited cultural and environmental contexts. For example,
the use of cane or barnboo was accepted in one culture (Baneji & Bane rji, 1986), but
may be deemed too primitive in another culture and less durable in a different ciimate.
One Canadian rehabilitation professional involveci in CBR in the Solomon Islands
comments: '4 was getting material on appropriate technology and damned if anyone
wanted anything B e that They would Say 'Get me a proper metal leg'. They didn't
want thmgs made out of coconut husks. Things weren't as simple as they fim appeared"
(HiII et al., 1997).
ûther devices that have been developed are misshg critical elements of the above-
mentioned aiteria of Vos and coileagues (1993). thereby reducing the suitability of the
devicekradctrdopmg-. W a t r t l l r f k % ~ ~ I h e ' ~ t r i ~ p t h e s i s ' for rrie
as a substitute for an above-knee prosthesis. The advantages of this device were its low
cost and simple structure. However, the excessive weight and cosmetic appearance were
considered unacceptable to a majority of patients who tested the device (Dickstein et al.,
1989). Jacobs (199 1) introduced the 'landmine boot' for use with patients cecovering
h m fhctures of the foot a d o r ankle joints following a landmine explosion. The boot
prevented any movement of disrupted joints and demased pain while walkuig.
Unfortunately, the landmine boot, which was made of highquality footwear, required the
help of orthotists and bootmakers for its manufacture and these were not available in most
remote nual areas.
2.5 Problems in Accessing Technology and Developing Technology
The challenge for the developed world is to share with the developing world in terms
of support, assistance. and teacbg without imposing foreign values and assumptions.
Ohey and colleagues (1 995) developed a compendium of Rehabilitation Technology in
Community Based Rehabilitation, within which several articles are cited that outline the
concems of fostering dependency on foreign rehabilitative technology (Olney et ai.,
1995). Coe and Banta (1992) report that the majority of Latin American countnes
continue to be dependent on the industrialized world for health care technology. A
disconcerting fact in their report is that initial dependency fosters more dependency. even
d e r the cost of the device has been paid Nice required cost related to normal wear and
tear, servicing, parts, and trainhg are not included in the purchase price (Coe & Banta,
1992). In another Latin Amencan study, of the 1,289 pieces of medical technology
(w& W F ~Uhs h ad+ impor~dbe~eea-L934=CP3pi 95% was out of semice by
1982 (Villegas, 1983).
The issue of a dual society in developiog countries has been described as one factor
contributhg to the lack of access to appropriate technology (Sethi, 1989). The rich urban
elite living in the developing world are! ofien the market forces within these countries and
they usuaily prefer the sophisticated technologies and designs that have evolved in
developed countries. Unfortunately, these are also the people who influence the
importm of devices, thereby Ieaving the poor majority without a voice or without the
knowledge, means, and available t h e to access technology. A concentration on high cost
technology hinders significant progrws towards more appropriate s e ~ c e s for the
population at large. It is aiso important to note that the majority of rehabilitative services
in both developed and less developed countries do not require sophisticated technology
(Peat & Boyce, 1993). By using the most inexpensive devices, the majority of people may
benefit, rather than merely parnpering a few elite people (Eyre-Brook, 1986).
In India, policy makers have expressed the view that amputees should be given the
latest and best prosthesis available. Mohan (1986) explains that 'latest' should mean
what is being designed now or in the fiiture within their own country and not necessarily
that which is being used in high-incorne countries. Similarly, 'best' should be the device
that achially gets used by the amputee and is aot unattainable in ternis of cost or available
materiais. Prosthetic users who cannot Bord repairs or replacement devices and do not
receive any assistance fbm govemment agencies are left unable to use theù prosthesis.
Vossberg (1985) explains that during the United Nations Year of the Disabled, a
consensus was reached by a grop of international experts that highlighted the need to
consider the Mique economic, social, culturai and environmental fiictors of each legion
-- -- -- w ~ C ~ V ~ ~ ~ ~ S ~ . --8mbu)a&k &ids that Mt*
such indigenization of orthopedic technicd seMces will break the dependency on
monetary investments (Vossberg, 1985).
2.6 Evaluation of Prosthetic and Ambulatory Devices
2.6.1 Reasons for Device Assessment and Importance of User Input
2.6.1.1 Within Developed Countries
Assessment of health care technology is a practice that is used to objectively
evduate the suitability of new technologies. The critenon by which one judges the
suitability of an assistive device depends primarily on the purpose of the evaluation.
Batavia and Hammer (1990) suggest that the involvement of the consumer in the device
evaluation process has been effectively used for clinical evaluation, the prescription of
devices, and to detemine how devices should be designed, manufachued, and selected to
prevent device abandoment (Batavia & Hammer, 1990). Studies have also been
conducted to assess usage or non-usage of assistive devices issued by therapists and
considered user input to be necessary to complete this process (Neville-Jan et al., 1993;
Seeger & Fisher, 1982; Kopp, 1962). in other cases, evaluative studies assess factors
such as the weatinng pattern and skilled use af the device, taking into account both user
and observer perspectives (Balance et ai., 1989). Scherer (1996) stated that reasons for
the evaluation of assistive devices was to examine the ways in which they improve or
detract k m an individuals' quaiity of life. She believed in the importance of shidies
conducted under varying enviroments and situations and with different devices in order
to gain a full understanding of their use. Furthemore, clinical and cconornic evaluative
- - - . . r r m n w w e n ~ ~ b y ~ a a t i w r P ~ e t l ~ m e ~ ~ ~ r e s 0 ~ ~ e r e b e i n g
allocated appropriately (Laupacis et al., 1992; Ganii & Birch, 1993).
Under more general evaluative conditions, Banta (1981) identified three major
concems related to technology assessrnuit: eflcacy relates to the probability of the device
to benefit its user; safeîy refers to the acceptance of the nsk of device use; and risR is the
probability of an adverse outcome with device use. Banta contended that many devices in
developed countnes have been used extensively without an adequate assessrnent and in
some cases the device is of little value to the user.
One problem with device evaiuations in the past is that they often only entailed
either tests of the structural aspects of the device design or an evaluator's observation of
the user's functional capabilities. Thus, the user was often not given the oppomuiity to
provide any formai subjective input to the evaluation process, which led to dissatisfaction
and eventuai non-use.
in 1990, Batavia and Hammer desded the importance of user input towards
device evaluations, but discovered that there wem no comprehensive consumer-based
criteria by which one can assess these devices. Orpwood (1990) identified a user
interface between the human body and an assistive device tbat m u t be assessed in
isolation h m the other features of the device during device development. This user
interface is compriscd of the design features that directiy interact with the anatomîcal,
physiological, or psychological variables of the user. For example, the user interface of
ao elbow catch is the 3-dimentional geornefry and texture of the handle, which is closely
associated with the anatomy and physiology of the h a n d User feedback regarding this
intedace during the development of any device is considered to be an essentiai
component to design saccess in terms of fimction and user satisfaction.
hrrreentyaa, ' e f i e n ~ t ~ ~ ü n e n ~ b ~ m e - e ~ ~ y €+the m8jOrieof
rehabiiitative programs, but the evaluation process of assistive devices has not yet
achieved this level of focus. In a review papa on outcornes of assistive technology,
Scherer (1996) recognized that despite the advances in consumer-driven device
evaluations, client input as an adjunct to the structurai and functional testing of devices, is
stiII not well established by the majority of device developers.
2.6.13 Within Developing Countries
The ultirnate goal of assistive rehabilitative technology in the developing world is
to provide persons with functional limitations with readily available, standardized devices
in the most cost-effective way (lames, 1984). With this goal in rnind, an assessment of
technology in the developing world serves the sarne purpose as assessment in the
developed world That is, it creates an assurance that technology users are provided with
senrices that meet their specific needs (Banta, 1981). There is also a similarity in
developing countries in that success of a new technology most often depends on the full
participation of the user and community throughout the entire production and evaluative
process. When adapting a currently used technology h m the developed world for use in
the developing world, it is equaily appropriate to engage the community as early as
possible thughout the design and testing phase. in the pst, this process has not been
undertaken and the failtue of many technologies has been the inevitable result (Datta et
al.. 1992; James, 1984; Banta, 1981; Sipila, 1977). In India, a 75% rejection rate of lower
limb orthoses was due to a lack of understanding of local conditions and ignorance of rml
patient needs. This situation could have been remedied by taking into accotmt local
climate, customs and culture (Oba & Thangavelu, 198 1).
-- - M ~ ~ e s ~ t ~ e ~ ~ t f ~ ~ ~ ~ e ~ ~ d e v e i o p i n g e o u n ~ a i & ~
determining what kinds of assistive devices the community membea consider useful and
adequate. This important questionhg and observational penod is known as the 'ne&
assessment' stage. The outcome of this stage is an identification of user roles and
responsibilities within the community and a determination of how, where, and when the
rehabilitative technology will be used (Mulholland, 1998). Technological solutions must
respect varied life styles and cultures and permit users to integrate into their environment.
Therefore, an assessment of cultural identity and the values and noms that go dong with
a paaicular culture must be conducted (Scherer, 1996).
Field-testing of the device represents another aspect of the assessment pmcess,
which also relies heavily on user input There should be an intensive interaction between
the workshop and the field h m the first introduction of the device through to its final
design. Dr. Knud lansen, founding president of the International Society for Prostbetics
and Orthotics (ISPO) comrnents, "Sensitivity to user reaction is a more sensitive tool for
designing appliances in developing counûies, than in an extensive laboratory back up"
(Sethi, 1989). Adherence to this way of thinking rnay see the fïrst generation of assistive
devices as being full of mktakes, but with ongoing feedback, mbsequent attempts should
be increasingiy successful (Sethi, 1989; Mohan, 1986). The success of the Jaipur foot in
India is one example that resulted h m a constant interaction between the laboratory and
the field (Sethi, 1989)-
- - Z 6 ; 2 D e v i . c e - ~ M ~ t a g i e s
2.6.2.1 Within Developed Countries
Despite the recognition of the need for users to contribute to the evaluation of a
device, comprehensive measures incorporating this need are scarce (Scherer, 1996).
Many studies assessing lower extremity prosthetic devices in the developed world have
examined the user's functional ability in terms of walking (Dickstein et al.. 1989;
Anderson, 1980; Moore et ai., 1989: Steinbert et al., t985). However, the h c t i o n d
capacity of an individual is multi-faceted and measures with only one variable have less
content validity (Bork, 1993; Sim & Amell, 1993). Furthemore, a primary focus on
physical facton related to prosthetic use from an outsider's perspective ignores the
psychological, social, and environmental factors as an integral part of successful use
(Gauthier-Gagnon et al., 1 998).
Some authon have reported subject evaluations of a device andior functional
capabilities using measures designed specifically for their study (Sheredos, 199 1 ;
Pohjolainen et al., 1990; N m g et al., 1984; Kegai et a[., 1978). Although reliabiiity and
validity information is not avaiiable for these measures, their use may be considered
applicable for the assessrnent of other devices. Pohjlaioen (1990) reviewed the functiond
success of prosthetic ambuiation according to different Ievels of amputation and the social
adaptation. Factors examined in this study-included place of abode, amount of personal
assistance, employment, time spent using prosthesis, and extent of mobility. An
evaluation of the VAtSeatile ankle included a short questiomaire that was adnhistered
&a a 30 day nial p e n d Items included usage of device, activities performed with
device, a rating of the level of di f f id ty while perfomiing certain activities ( w a k g
= -- s b b , wldkb&nat, mmmig, gomgapW,-dowPk~upstaVs, 8ownsh- anb-g
on uneven terrain), noticeable hc t ion of the device, general comments to assist the
improvement of the device, and overall acceptance (Sheredos, 199 1).
Very few valid and reliable comprehensive instruments have been specitically
designed to measure user-reported acceptance ancilor perception of fiinctional
performance of a prosthesis or other ambulatory device. Day (1981) made an early
attempt at the development of a measure of the activity level of a penon with a lower
extremity amputation using a prosthesis. However, this questionnaire is not inclusive of
the factors related to the evaluation of a prosthetic device, such as acceptability and
nasons for use or non-use. Bilodeau and colleagues (1999) developed the SAT-PRO, a
15-item self-administered questionnaire, to determine the level of prosthesis satisfaction
among users. A high intemal consistency value of 0.90 and test-retest reliability
coefficient of 0.97 was found for the French version of this questionnaire. Unforhmately,
an English version has not yet been published. Legro et ai. (1998) created the Prosthesis
Evaiuation Questionnaire (PEQ) as an effective user evaluation of prostheses and
prosthesis-nlated quality of life. This m e a m a d h s e d prosthetic function (usefulness,
residuai Iimb health, appearance, and sounds), mobility (ambulation and tramfers),
psychologicai and social factors (perceived responses by others, nustration, and social
burden), and ovedl welI-being. A visuai analogue scale was used for the response
format The PEQ has shown good psychomeîrïc propehes: intemal consistency values
ranged h m -73 to -89 and validity measurements indicated significant correlations
between three published scdes of generai health status and mood states.
Grise, Gagnon et al. (1993, 1994) designed and tested the Prosthetic Ronle of the
Amputee (PPA). This questionnaire, actministered in both telephone and mail versions, is
intend& t e eraluate the ~ ) c d l e u e L & p&ie use and detemUne &ctos
related to pmsthetic use or aon-use by a person with a lower extremity ampumaon. The
PRECEDE theoreticai mode1 (Predisposing Reinforcing and Enabling Causes in
Educational Diagnosis and Evaluation) f o m the theoretical bais for the PPA (Green et
al., 1980 in Grise et al., 1993). Forty-four questions (nominal, ordinal and ratio scales)
are groupeci under 6 themes: physical condition mealth problems, problems with non-
amputated leg, midual limb problems); prosthesis (satisfaction, adaptation, fit,
accessibiii~ to laboratory); prosthetic use (ability to don, locomotor abilities, activity
level, frequency of wear, percentage of displacements both indoors and outdoors, walking
distances, number of falls, automatism of w a k g , wallang aids used, reasons for non-
use); environment (living arrangements, place of abode, barriers, physical help by others,
others' acceptance); leisure activities (sports and recreation), and general idormation
(vocation, education, socioeconomic status). This questionnaire has demonstrated
rdiability and validity for clinical and research use (Gauthier-Gagnon, 1994). The PPA
has also been demonstrateci to be valid and reliable in its French version and has more
recently been tnuislated in a Spanish version.
The Iocomotor index is a 14-point subscale of the larger PPA. The authors have
demonstrated interna1 consistency for its use on a more specific basis to identify the
capabilities of the prosthetic user (Gauthier-Gagnon et al., 1998). in an investigation
conducted by the Scottish Physiotherapy Amputee Research Group (SPARG), the PPA
locomotor index was recommended as a rneasure for fimchonal outcome in place of the
previously used Barthel index and Russek's classification for lower limb amputees. The
PPA locomotor index was selected for its seasitivity to ciifferences in functiond outcome
- - - - - klase&magc& lwet of asweErts(htkkof a flot?€ or a &lutg e R i t
when cornpared to the other two scdes (Treweek & Condie, 1998).
2.6.2.2 Within Developing Counties
There is paucity in the literatwe on client-based evaluations of prosthetics or other
ambulatory devices within developing countries. Oniy three studies were Found which
reported on evaluations based on the essential criteria of user input were cited. Vos and
colieagues (1993) evaluated the use of a newly designed wheelchair developed for use in
third-world countries. Subjects evaluated the wheelchair for a period of one month based
on the following criteria: cornfort, maneuverability, ease of transfers to and fiom, and
adequacy of parking breaks and foot nsts. Matsen (1999) administered a field survey
questionnaire to Vietnarnese amputees to determine the use of prostheses. Questions
addressed tasks such as; going up/down stairs; walking while carrying increasing weights;
and maximum waikhg distance tolerated without rest. In india, functional variables on a
prosthetic questio~aire addressed the ease of getting in and out of chairs as well as the
ease of managing curbs and ramps (Narang et al.. 1984). Each of these variables was
considered during the development of the questio~aire that assessed the HFC within the
context of El Salvador. Cultural, environmental and device-specific diBeremes were nrst
determined so that any necessary adaptations to the above-mentioned measures could be
made.
Since cultural and enviro~3enta.i factors are unique to each country, the
measufement tools and outcornes identified in the developed and developing world could
be b d t upon once the needs of the specific country were known.
In recent years, an increasing number of outcome mesures have been used to
evaluate physical function and quality of Life of iodividuals following a lower extrernity
injury or amputation. These generic measures have been applied to a variety of
individuals, including those with lower extremity amputations and injuries. The SF-36 is
one such instrument, which measures the quality of life of the client and has been
demanstrateci ta have good reliability and validity (Ware & Sherboume, 1992). The SF-
36 measure has been used in at Ieast one study to assess the physical and social function,
role limitations, mental health, energy level, and general health perceptions of subjects
with a TTA (Smith et al.. 1995). Finch & Kennedy (1995) have also developed the
Lower Extremity Activiv Profile as a m a u r e of disability. This questionnaire examines
the client's perception of difficulty and satisfaction in the following functional a=:
self-cm, mobility, household activities, w o 4 leisure activities, and social activities. The
intemal consistency and preliminary validity testing of this measure were found to be
moderate among a population with osteoarthntis undergoing a total h e e replacement.
The Barthel index, a widely used measurement of rehabilitation outcornes, has also been
used with lower extremity amputees as an indicator of functional abilities and
rehabilitation outcome (Kuliman, 1987; and Goldberg, 1984).
2.6.4 Instruments Used for the Current Study
This study reguired the development of a multivariate, culture specific tool for
ssessing ambulatory devices. Due to a lack of Iiterature on the assessrnent of ambulatory
devices in deveioping countries. it became eident that a study-specifïc assasment
measme wodd have to be developed, which incorporateci the specinc culture and
-- - ewhnmene SE Ek Wv&. k&bgsi9-fep this-nwawe, seved q u e s i o h an&
functional tests were identified for their potential use in a developing country. The PPA,
the Lower Extremity Activity Profile, the questiomaïre by Sheredos (1991), and the
questionnaire by Matsen (1999) each contributed to the questionnaire developed for this
study. Also, since a comprehensive objective hctionai test was not found, a
modification of the Locomotor Index of the PPA was made. The addition of cultural
items to this Index, contriiuted to the objective fuoctional measure for this midy.
Detaib on specific items taken fiom each of these rneasures, in addition to the
completed questionnaire and functional measurp will be discwed in Chapter 3.
2.7 Rationale for Methodology
During the development of mos t new rehabilitative technologies, experimental
designs used to assess the new technology often follow a pre-experirnental design, case
midy format. This design is useiùl in the early stages since data collection can be quick
and provides useful insights into whether or not any design modifications need to be
made. However, without a control group or randorn assignrnent of subjects, this type of
design holds many threats to intemal validity and should not be used to demonstrate any
cause and effect relationships (Bork, 1993).
In cases where the assistive technology is meant to replace existing technology, a
repeated measures within-subjects design has Çequentiy been used (Arp et al., 1995;
Hsu et al., 1999; Lehmann et al., 1993; Schneider et al., 1993). In many of these studies,
subjects test the first device followed by the second device. The dependent variables in
these studies are usually not susceptible to order bias or fatigue effects, since adequate
rest periods are given pnor to the initiation of the second testing period However, if the
dependen& vanôb1e- ismulti-ktcs&su&irs I e u e L a f ~ t i n n and va&us fiinctinnal
performances, the order effect of the device testing can bias nibjects' preference and
performance towards the device tested first
For this study, a crossover design was believed to be the most appropriate means to
assess the HFC. Use of this design enabled severai threats to intemal validity to be
contmlled Reversing the order of testing for half of the sample controlIed for any
'learning', such as ability to balance and walk using an assistive device, that might have
occurred after the first triai. Aiso, each subject was required to test both devices that
were being compared, which assured the highest possible equivalence on demographic
characteristics among subjects (Polit Br Hungier 1997). The possibility of matching a
control group to the experimental group on the basis of several demographic
characteristics was also considered This design wodd have reduced the tirne
cornmitment required by subjects since each subject would need to test oniy one device
instead of two devices. However, assessrnent that is undertaken within a developing
country, where testing sites and subject recruitment are not ideal, cannot guarantee a
match for each subject. Therefore, using the same subject as hidher control in a within-
subjects, cross-over design would allow a larger subject pool and p a t e r assurance that
subject characteristics duriag testing the two devices were equivalent.
2.8 Relevance of Research
The reievance of this study Iies p M I y in the fact that it addressed basic human
needs within a context of post-conflict development in a poor country. Improved quality
of He among persons with amputations and persons with lower Limb injuries is
considered to be one of the major goals of programs concemed with appropriate
rehabifitativet~~logy. Ia cornpima-witfrtbeuseof axillaF)r csutches Csee Sectio~
2.4), the HFC was anticipated to enable walking in a more aligned upnght position
resuiting in irnproved posture that wouid promote cardiovascular and respiratory fiinction,
to allow more mobility and exercise, and to improve psychosocial affect.
The m l t s of this project could be beneficial in deteminhg the feasibility of
introducing the HFC device in other developing and war tom countries within Latin
Arnerica, South-East Asia, Anica, and Eastern Europe. In many of these countnes, it
may take months before a prosthesis is manufactureci at one central location within the
country, then received by the user. in other cases, the delayed healing of a residual limb
suture line prevents immediate prosthetic use. Furthemore, patients who have an ankie
fhchire or s p i n are left unable to bear weight for a certain period of time and must rely
on axillary crutches to fimction. The introduction of the HFC as a short-term solution to
these problems has the potential to d o w increased fiuiction by aflowing hand and arm
&dom, at an aordable cost. Similarly, there is a potential for long-tenn use of the
HFC as an alternative to prostheses or in situations where extended or indefinite use of
axillary crutches is necessary. With the anticipated use of Local materials into the
fabrication of the HFC, the cost could be comparable to that of axillary crutches.
Therefore, a detennination of HFC bc t ion and cuiW acceptance is expected to guide
f h r e shidies of HFC and its ongoing development in developing and war-tom countries.
- eEWTER3. ~ O D O E O E - Y
3.1 Study Design
A crossover experimental design was used for this study. Half of the participants
were systemriticaily assigned based on birth month to skut with the HFC, then to switch
to ACs. The other half of the subject pool started with AC, then switched to the WC.
Whenever possible, testing occurred at subjects' homes.
3.2 Participants
Inclusion Criteria
Over the age of 18 yean;
Unilateral trans-tibia1 amputatian or a hcture of the ankle or foot requiring a
period of at least 5 weeks non-weight bearing. This critenon was based on the
restriction imposed by the HFC derice itself shce it had ken developed to bear
full body weight through the knee;
Active and mobile, with good static and dynamic single-leg balance.
In an attempt to restrict selection bias towards subjects who were farniliar with AC,
a strong effort was made to approach potential mbjects during the fint few days d e r
lheir surgery or injury to aUow an e@ chance of exposnrr to eimer device.
Exclusion criteria
Roblems with the unaffected leg, such as arthntis, or other pre-exining condition
or injirry;
Major PR-existing gait abnormaiities apart h m the amputation or injury;
Major residual Iimb a b n o d t i e s (e-g. resimiaI limb length too short, tendencies
toward flexion contractures, or bony prominences);
- - * Anyprroiarrsorensting~*iareepattiotogn~of~aff~dkg;
Any restrictions preventing full weight-bearing through the knee on the affecteci
leg (e-g. proximal tibia-fibula hctures and/or a long-leg cast)
3 3 Recruitment and Sample Size
Subjects were selected h m a sample of convenience. This choice of sarnpling
procedure was made as a result of transportation issues within El Salvador. The poor
idhstructure of the roads rnakes travei very slow and dificuit, especidly when relying
on public buses which fiequently break down. Cowequently, the recmitrnent area for this
study was concentrated on the central and western parts of El Salvador, where the roads
were in relatively good condition and an adequate number of hospitals were situated.
Although the war was fought primarily within the Northem and Eastern regions of El
Salvador, the land has been almost completely cleared of unexploded ordnance and new
injuries or amputations rrsuiting from land mines are infiequent. At the time of this
study, the majority of injuries and amputations in El Salvador were the result of trauma or
health-related problems, such as diabetes. Therefo~, the sample selected for this study
was believed to sufficiently represent the population of people with a trans-tibia1
amputation (TïA) or a lower limb injury h u g h o u t the entire country.
Subjects were recruited h m six acute care orthopedic centres/hospitals throughout
El Salvador. Five of these locations were govemment h d e d public sites and one was a
private haspital. Prior to sample recruitment, the researcher met with each of the six
hospital administrators to disniss the snidy and to obtain verbal endorsement. The
researcher was also invitexi tu speak at a National Physiothempy Conference to raise
awareness of the HFC and create more opportmiities for subject recniitment,
S a m e sire &ui&ms take inte m e ~ v d ~ f o p the le& d sigeificeoce (a),
the desired power, and the effect size. Parameters selected for this study, using sample
N e tables (Cohen, 1969) included a equd to .OS, power set at 80%, and a medium effect
size of 0.5. The fint two parameters were based on the most comrnonly accepted values
as outlined in several statistic te- (Hulley & Cummlligs, 1988; Cohen, 1969). Effect
size is often based on previous studies or pilot tests. For this particular study, it was
determined that data in the pilot study of the W C v e m AC in Canada resulted in a
medium effect size (Dalton et al,, 2000). Thetefore, an examination of sarnple size tables
with the use of these three parameters (a, power, and effect size) indicated a required
sample size of 50 (Cohen, 1969). However, feasibility restraints that were present in this
study made obtaining a subject pool of this size quite difficuit. As a result, the maximum
number of possible subjects that could be obtained was estimated to be thirty and the
power of the study was necessarily decreased to 60%. The result of this decreased power
was that the probability of rejecthg the nul1 hypothesis (Le. there are no differences in
subject acceptance and functional scores between the HFC and ACs) would be less than
desired.
Participant names were obtained through consultation with attending
physiotherapists, social workers, W o r orthopedic surgeons at each institution. Subjects
were first approached either in the hospital or at their home. In each case, the researcher
and a translator, without the presence of the treating medical professional, approached
subjects. If the inclusion and exclusion mitena were me4 subjects were invited to
participate in this study. Qum's University and Affiliatecl Teaching Hospitais Ethics
Board approved the protocol for this study. The translator clearly explaineci the
objectives and the methodoIogy of the stady as oatimed on the idormation/consent form
(Appedk A, Bb This i n f ~ O Q C e ~ & f o ~ M b e e f t &mslated k m En@& te
Spanish in written form, and then read by a dinerent tra~slator back to the researcher in
English to assure consistency in words. Once this form had been read to them, subjects
were given the oppominity to seek clarification. Pnor to beginning the study, they were
asked to sign the consent form. One copy of this fonn was then retumed to the researcher
and the subject retained the second copy. Names and phone numbea of the researcher,
translater, and a contact at the hospital were provideci to each subject. They were
encouraged to inform any one of these persons in case of any problems that rnight ensue
during the course of the two trial penods.
The tnuislator used for the duration of the study in El Salvador was well qualified for
this responsibility. In addition to studying English for over 10 pars, she had also
completed two years of full time study at a well-established school in El Salvador leading
to a career in translation. Her excellent grasp of the English language in both written and
verbal form and her skills in simuitaneous translation added to the reliability and intemal
validity of this study.
3.4 Randomization and Procedures
Subjects were systematically assigned to £hst trial the HFC or ACs based on the
month of their birth. An odd numbered birth month (January, March, etc.) meant the
subject evaluated the HFC first. An even nurnbered birth month (February, April, etc.)
meant the subjects tried ACs first To ensure consistency of device fitting, the mearcher
was responsible for fitting ail of the HFC devices and ACs prior to each triai. Subjects
were givm a two-week period to trial the HFC and another two-week period to triai ACs
(vise versa for the other half of the subject pool). The selected duration of the trial period
L - witlpirragmment witbpmiou4 e o m ~ v e p r ~ ~ d r t m ~ t o ~ es, w k k t
have allowed a two week to one month period of accommodation to a new device prior to
testhg procedures (Postema et al., 1997; Powers et al, 1994; Torbum et ai., 1994,
Stallard et al., 1978). At the end of each two-week trial period, the questionnaire and
functional tests were administered to each subject.
There were two types of crutches used in this study. One of five prototypes of the
HFC, (weight: 1.9 kg; tibia1 tray length: 3 1 cm) was issued to each subject just pnor to
the trial period Subjects were informed that they would be asked to return the HFC at the
end of their triai period so that they could be tested by other study participants. Each
subject provided their own wooden ACs, which were either rented, bought, or in three
cases, homemade. The mearcher was prepared to provide a limited nurnber of ACs,
which proved to be unnecessary. Although the weight of the subjects' ACs was not
taken, the weight of a set of standard wooden ACs in Canada is 1.9 kg.
Prior to the trial period of the WC, al1 subjects were monitored for gait training and
safety issues by the researcher and, if available, the treating physiotherapist. Once
subjects had been tmined and dcmonstrated safe use of either the HFC or ACs, they were
instnxcted to go home and try using the HFC or ACs as much as possible for their usud
Ievel of daily activities both inside and outside the home. They were told they wotdd be
questioned about their performance and demonstrate some of these activities at the end of
a two-week period.
Several methods were used to prevent subject @out h m this study. First, every
effort was used to Iocate each subject at his or her home for follow-up testing. Second, if
subjects completed only part of the two-week trial period, testiug stiU proceeded with the
device in question since the data in these aises were vatuable for determinmg reasons for
non-use Oaedropoutdibocc~~~raissiog~~we~eeeke~ieteacceunidur ing
statisticai analysis of the resuits.
3.5 Instrument Development
For the purposes of this study, the mearcher developed the Lower E v t d t y
Assistive Device -Acceptame (LEAD-A) questio~aire (Appendix C, D) and the Lower
Extremity Assishve Device Performance (LEAD-P) measure (Appendix E, F). M e r a
thorough Meranire searcti, it was determineci that the* was no comprehensive meanue
that could effectively be applied to prosthetic or ambulatory aid usen within a developing
country. In the developed world, there were several measures with demonstrated validity
and reliability, which had the potentid to contribute to the LEAD-A and the LEAD-P.
However, functionai and cu1turaI needs are usually quite different in a developing country
and any measure taken nom the developed world would require modifications and
additions to reflect these needs.
The addition of the LEAD-P to this study was to provide an objective measure by
which to vaiidate the subjective responses on the LEAD-A. Recent studies have
supported the importance of using questionnaires, consisting of clients' subjective input
of their satisfaction with social and fiuictional abitities, in combination with observationd
fiinctional and clinical tests (Finch & Kennedy, 1995). Together, these two types of
measurernent tools assisted the researcher in detemllning the relationship between the
subject's perspective and observeci hction.
Questionnaire
The questions on the LEAD-A were largely based on the PPA questiomaire,
which was developed, in part, to evaiuate factors related to prosthetic use (Grise et al.,
1993). The PPA authors demonstrated good face and constnict validity of the PPA and
strong test-retest reliability with Cohen's kappa values of 0.92 and 0.80 for continuous
data, 0.46-0.84 for ordinal data, and 0.60-0.86 for nominal data (Gauthier-Gagnon &
Grise, 1994). Based on its intended use, a few PPA questions were specific only to
prosthetic users and not to a general evaluation of ambulatory aids, such as the HFC. For
exampie, questions nlating to phantom pain on the amputated lirnb, usage of different
types of prosthesis, and adjustment to an amputation were not appropriate for this study.
However, there were many guestions that were suited to this study and served as the
foundation for the development of the LEAD-A. A m e r reason for use of the PPA was
its prior translation into Spanish, which greatiy Eicilitated the translation process of the
LEAD-A when technical words were involved
The second questionnaire that conaibuted to the LEAD-A was designed
specificaiiy for a study evaluating the use of a new prosthetic d e (Sheredos, 199 1). In
this very short subject evaluation form, there is a section with questions pertaining to the
use of the prosthetic M e during severd functional activities. Al1 but one of these items
were included in the LEAD-A for their importance to ddy functioning within El
Salvador. The question conceming nmning was not feasible for the testing of the WC,
particuiarly when balance and safety issues for this device have not yet been fomally
evaiuated. Although Sherredos did not use a comparative design, the final question
- - ~ e q u e s t ~ ~ q ~ i h ~ v e s&tement&-subje&- preférenee-og eirher the m w OF th& own
prosthetic ankle. This qualitative type of question was included in the third part of the
LEAD-A,
Finch and Kennedy (1995) developed the Lower Exaemity Activity Profile for use
among clients with osteoarthntis who were undergoing a total knee replacement. This
questionnaire has good intemal consistency with a Cronbach's alpha of 0.73. Although
the purpose of this measure was more related to quality of life than the assessment of an
assistive device, there were a few items that were worth exploring. One of the objectives
in the development of the Lower Extremity Activity Profile was to address individuals'
satisfaction with their ability in perfomllng an activity. Performances in the following
areas were adkssed: self-care, mobility, household activities, work, leisure activities and
social activities. Since each of these areas may not have applied to al1 subjects, and
because the researcher was still leamhg about cultural activities in El Salvador, it was
decided to provide an activity-related open-ended question on the LEAD-A. Subjects
were asked to identify activities they necessarily performed each day (i.e. self-care,
household activities, and work) and activities that they enjoy dohg in their spare thne
(i.e. leisure and social). With a qualitative response, subjects would be able to identiQ
the areas of daily life that are meaninghil to them.
FinalIy, a study among Vietnarnese amputees was useful in determinhg the
important demographic factors (Matsen, 1999). These factors included: height, weight,
gender, location of home, occupation, date of amputation, and associated medical
conditions. Items that were added to the LEAD-A in the demographic section were: did
the subject have a fracture or an amputation; had hdshe used crutches before and if so,
how long and was helshe taking any medicatiom. The last item was included for the
rescstfck te &Cnmne ~ & - o r mt these r n e d h b mul& Iiave irnpt& oi,
subject's balance or functiond performance.
Specific sections that were added by the researcher to the questionnaire were
considered to be important to assessing the HFC within the context of El Salvador.
Riding an overcrowded public bus at least twice daily is a necessary activity for a
majority of people living in El Salvador. Gettiag in and out of a car or taxi is another
necessary activity for some people. The bathrooms in El Salvador are often either very
mal1 inside the home, or are a built up cernent hole in the ground outside. The item of
getthg on/off the toilet was included after visiting several homes and consulting with
rehabilitation experts within the country. These three activities were added under the
section with difficulty ratings of the device. in the section on device non-use an item
concerning use of the subjects' han& was added. Since the primary purpose of using the
HFC was to dlow an individual's hands to be fiee, it was essential to detemine whether
or not this was an issue arnong nibjects using ACs.
Table 1 shows the content of the LEAD-A and beside each item on the
questio~aire is the original source of the specific item.
- .
~ a b l e 1 Contents of the LE- LEAD-A Part 1 Demographic In formation Part 2 Usage
days, h o u DigdtyVease of use
wallcing: slow/fast Stairs: up/down Hill: up/down Uneven tenain Bus: odoff Car: inlout chair odoff Toilet: odoff
Device Satbfuction cornfort, appearance, weight, gait
Doilypercentage of use with device Indoors and Outdoors
Device non-use Speed Fatigue Hands not fke Non-affiected leg problems Device problems Instability
Number of Falls Part 3 Qualitative cornparison
Daily necessary activities Leisure1y activities ~ ~ i m p r e s s i ~
OveralZ preference
SOURCE
Grise et al., 1993: PPA
Sheredos, 199 1 : evaluation of VAISeattle ankle Sheredos Sheredos S heredos Researcher Researcher Grise et al. Researc her
Grise et al.
Grise et al.
Grise et al. Grise et al. Researcher Grise et al. Grise et al. Grise et al. Grise et al.
Finch & Kennedy, 1995 and Author Fincft & Kermedy, tg95 end Author Sheredos Researcher
Part 1 of the LEAD-A instrument consisted of demographic idormation about the
subject. Part 2 consisted of questions based on an ordinal scde as weli as y&no
responses. Part 3 of the LEAD-A was administered after the second trial period at which
point subjects were able to compare the HFC and ACs. Part 3 consisted of the same
questions as part 2 with the addition of tbree qualitative comparative questions relating to
38
- -- - the aetivitb @&me& witk the- ~ ~ d e v i e e f ~ & leiweiy) smt fe8çons f t
device preference. A combination of qualitative and quantitative outcome strategies cm
strengthen the externai vaiidity. Increasing the amount of information available for
anaiysis and interpretation of the data dlows a better understanding of subjects'
experiences (Goodwin & Goodwin, 1994).
3.4.2 Lower Extremity Assistive Device Performance (LEAD-P)
Measure
In a review of scales that were used to measure the mobility of people with lower
limb amputations, Rommers and colleagues (2001) uncovered a lack of consensus in
recent literature. They dso found several scales being used that consisted of very few
functional items and therefore, couid not possibly give a clear indication of ovedl
mobility.
Consequently, the LEAD-Performance mesure was developed for this study and
consisted of nine fiuictional tasks. These tasks were modified fiom the locomotor index
subscde of the PPA questionnaire to permit an objective fûnctional performance measure.
Table 2 outlines the original item as stated in the PPA Index, followed by the
modification made for the LEAD-P,
In addition to the seven modifieci items h m the PPA Index, tiiere were two
additional items that were believed to be specific to El Salvador: 'Reach one hand over
head while maintaining good standing balance (as if riding a bus)'; and 'Open door, wak
through doorway, then close door'. Riding an overcrowded bus, where standing is a
necessity, is an everyday occurrence for a majority of Et Salvadorans who do not have
any other mean for transportation. AIso, the ability for a person to be able to open and
automatic doors are very infrequent.
Table 2 Modifications of the PPA Locomotor Index PPA Locomotor Index LEAD-P Reason for modification 1. Getting up fiom a 1,2. Move from standing p - needed to standardize
chair sitting position and h m test between subjects 2. Standing up sitting to standing position
fiom a chair without annrests 3. Picking up an object 3. Starting in a standing - needed to standardize h m the floor when you position, bend dom to flmr are standing up with and pick up a coin. Return to your prosthesis standing position. 4. Getting up from the 4, Ornitteci - not appropriate for non- floor weight bearing
restrictions 5. Walking in the house 5. Omitted - assurned able pnor to
beginning trial 6. Walking outside on 6. Omitted - assumed able even grouni 7. Waiking outside on 7. Walk up and down a 10m - standardue distance and uneven groÜnd inclined, Geven surface make more challenging
in environment where most outdoor surfaces are uneven
8. Waiking outside in bad 8. Walk 1 ûm across wet, - standardize distance and weather muddy terrain or area of tall, task since unable to
dense- grass predict weather 9. Going up Stairs with a 9, 10Omitîed - most stairs do not have
a hancirail in El Salvador
with a handraii 1 l. Going up a sidewalk 1 1,12. Step up and down a - no change curb 12. Going down a
sidewalk curb
sidewalk c h 13. Going up a few steps 13,14. Go up and down 5 - standardize number of without a hancirail stairs without hancirail steps and most stairs do 14. Going down a few not have a handrail in El steps without a hancirail Salvador 1 5. Waiking while 15. Carry a giass ofwater 5 - needed to standaridize
=-- - Seateapriomon*tEhD-P-franiete* )=unaC,Letvwmplete*
task; 2=cornpleted the task with much difficulty and required external support to regain or
maintain balance; 3=completed task with little difficdty and able to self-correct balance;
4=completed task with out any problerns. Again, scoring options on the PPA Index were
used as a guide for the LEAD-P, but scores needed to be written in an objective format
rather than the subjective responses given on the PPA Index.
3.43 Coding of Measures
Coding of ordinal and categorical responses was necessary for statistical analysis
of the variables on the LEAD-A and LEAD-P. Categorical data in the demographics
section was givea a code of 1 for the fint choice and a code of 2 for the second choice.
For example, coding of gender was as follows: maki, female=2. Home location was
coded as urban=l, rural= 2. ûrdinal data were assigned nurnbers ranging fkom O at the
negative end of the scde to 4 or 5 on the positive end of the scaie. 'Walk slow', for
example, was labeled as follows: Did not attemp~o; Atîempted, but unable to
completecl ; Very dBicuk3; Moderately difficul-; and No problems4. Subjects who
did not try a particular activity ( scor~0) were not able to grade its level of difficulty.
Therefore, for statistical purposes, scores of 'O' were identified as 'missing data' and
w a e not included in the analysis. Questions #5 and 7, relating to rasons for device non-
use, were labeled as y-1 and no=2. Question #8 relating to overall device preference
was f abeted as HFC= 1, and AC-2.
3.4.4 Reiiability and Validity of LEADA and -P
Throughout the entire process of refinùig the LEAD-A and LEAD-P in El
Salvador, the translater was present in order to assure that ai l subject or expert comments
wereeepftue8&rehyed=tebm&e&mhe~. There~e8~ehermuI& the& comment d t h c
translator would facilitate this interaction. A translator was also required to assist with
the translation of multiple revisions of the two meames. Once the final revisions had
been made, one translator translated a Spanish copy and another translator back-translated
this copy into English to assure that any discrepancies were resolved. The first translator
then translated the fuial English copy back into Spanish.
Attempts were made to accommodate the culturey environment, and language
dwerences between El Salvador and North America in the development of the LEAD-A
and LEAD-P. Sorne of the cultural factors that were considered were the subjects'
educational background, socioeconomic statu, familiarity with tests, gender-specific
d e s , and specific test-taking skills (Geisinger, 1994). ûptions as to the most appropriate
method for administration of the questionnaire were carefully weighed based on these
factors. Information to assist with this process was obtained through informal i n t e ~ e w s
among experts within El Salvador (Benson & Clark, 1992). The experts included
prosthetidortho tic instructors and technicians, physiotherapists, as well as people who
weE currently using ACs. Individuai interviews and informal focus groups were held in
order to assure that each important aspect relating to ambulatory device use in El
Salvador was addressed. Each draft of the questio~aire and performance meanire was
traoslated into Spanish and issued to the 'experts' involved for M e r input and revisions.
Smaii-scale reliabiüty and validity tests of the instruments following a brief trial of the
HFC were conducted in El Salvador. Two subjects with a ITA, each ushg a prosthesis
and one person with au ankle hcture using ACs were provided with a HFC and were
given a trial penod of approximately 30 minutes using the cxutches within the vicinity of
the centre/hospitai. The testhg instruments were then administered on site to each
--- - subjcsh %Now& by adebriefing- I b i i w t n m e n ~ w 9 6 ~evised and mat& ma
more times until it was acceptable to al1 of the experts involved. On-site inter-rater
reliability checks were conducted by comparing scons marked simultaneously by the
mearcher and a prosthetidorthotic technician or a physiotherapist. This assured that the
instrument was without contextuai or vocabulary difficulties. Another back-translation
method was completed as a M e r reliability check so that the results could be accurately
interpreted in English and Spanish @el Greco et al., 1987).
'Tnistworthiness' is the term used to describe reliability and validity of qualitative
data (Lincoln & Guba, 1985). Krefting (1991) reviews several strategies fiom the
literahue that were used for the establishment of trustworthiness. Knalf and Breitmayer
(1989) descnbe triangulation as a powerful tool to enhance the credibility of a particular
study. Triangulation of data includes a cornparison of data coitected by several different
sources. In the cumnt study, data h m the closed-ended questions on the LEAD-A and
observations made with the use of the LEAD-P could be compared with the qualitative
data reported by the subject. Multiple perspectives of this data collection are then cross-
checked against one anther. Triangulation of data sources in this study included testing in
diffêrent seasons (wet and dry) and having a range of dernographic characteristics to add
to a more complete understanding of the HFC use. During the i n t e ~ e w process,
crcdibility was m e r increased in this study by the refiraming of questions, repetition of
questions, and expansion of guestions (May, 1989).
3.5 Administration of Measures
Questionnaires have been identifiai as the most popular tool for assessing
satisfiction of assistive ambulatory devices and prosthetic systems (Romers et al., 2001;
-- . tegrv et ak, kW&; Grise et nf., kwEhtdtk& k948; kW3; Andei.s~h&
Wijesinha, 1980) The questioanaire format of the LEAD-A consisted of both open and
closed-ended questions and was believed to be the most appropriate method for collecting
subjective responses in a cross-cultural study. This format was relatively easy to
administer and subjects damiliar with tests could view, or be told, al1 possible choices
for each question, thereby obtaining a clearer understanding of each question. Subjects
were also invited to provide any particular comments regarding the questions at hand
The researcher later evaluated these responses as a means of gaining M e r insight into
the subjects' experiences with the HFC.
Self-administration of the satisfaction questionnaire was also considered.
However, subjects' lack of famïliarity with such tests dictated that the questionnaire
would more appropriately be admhistered in a modified smictured i n t e ~ e w format
With this format, the tmslator read each question on the LEAD-A, dong with al1 of the
possible response categories, to the subject If the subject was literate, he/she was also
given the questionnaire to read. if the subject was illiterate, the translator would read
each question and ail possible responses at least two times. For each question, the
translator diRctly recorded the subject's verbal response onto s questionnaire. During the
entire interview, there was a constant tramlator to researcher checking to ensure the
actual subject response was recordeci. Respoases were translated on site so that the
researcher and/or the subject could cl- any questions or discrepancies on the
questionnaire itself or in the subject's response. Each session was tape-recordeci, then
transmied by the researcher at a later time using the translater's English onsite
transtations in order to capture auy additional comments the subject may have made. if
chae W e q U B C k Passages, k ~ a p t m 9 i \ t e ~ 1 kFw € I W B ~ ~ O F who WQ& k k
listen and transcribe the section into English.
Whenever possible, testing occurml at the subject's home. It was beneficial to the
researcher to directly observe the subject in the location in which hdshe had used each
ambulatory devices and make note of any pdcularty difficult situations hdshe
encountered while using the HFC. However, for the convenience of the researcher and
subject, there were some subjects who ntumed to the rehabilitation centre or hospital for
testing and were reimbuaed for the cost of transportation.
Administration of the LEAD-A occumd before the LEAD-P so that any fatigue or
performance levels on the hctional tasks would not taint the responses on the LEAD-A
questionnaire. The translator repeated each item as it was stated on the LEAD-P to each
subject. As with the administration of the LEAD-A, there was a constant interaction
between translator and researcher to aensure that the subject undentood what was
nquired to perform to the best of hidher ability. During task performance, the researcher
observed its execution and scored each subject based on the 4-point scale.
3.6 Data Analysis
The qualitative and quantitative data were manually entered into a database created
in Microsoft Access for Windows 2000. Database searches were performed for rnissing
data or potential emrs in the data by constant cornparisons with original data sources of
the LEAD-A and LEAD-P or, m some cases, to the original tape recording of the subjecrs
in te~ew. The quantitative sections of the Access database were exported to the
Statistical Package for the Social Sciences (SPSS) 10.0 for complete statistical analysis.
3.63 ~ o m p a r i s o n ~ B e t w ~ ~ U s e o f T w ~ D e t r ' t c e ~
The t-test was selected to detennine whether or not use of the HFC resulted in
higher mean values on continuous variables. This test is fairly straightforward and is
widely used in health care research when continuous, normaily distributed, paired data is
examined.
The Wilcoxon Signed Rank Sum test was used to determine whether or not use of
the HFC resulted in higher median mtings on the ordinal scales of the LEAD-A and -P.
This test is especially usefbi for evaluations of the effectiveness of an intervention
provided that the data meet the critena of: being continuous, or at least ordinal in
masurement; paired observations; and h a d g symmeûical difference scores about the
median (Pett, 1997). To conduct the WiIcoxon test, several steps are required: kt,
differences in scom between paired data are cdculated and pairs without any differenca
are discarded; next, absolute values of these differences are placed in rank order h m
lowest to highest; the original sign (positive or negative) is then added to each rank
difference; al1 of the positive ranlcs and al1 of the negative ranks are summed and
averaged; and fially, the obtained values are substituted into an equation, which yields
the z statistic. This nurnber can then be used to determine whether differences between
positive and negative values am significantly large enough to reject the nul1 hypothesis
(Pett, 1997).
Resuitmgp values h m both the t-test and the Wilcoxon Signed Ranks test used in
the current study were considered statistically signifcant using a one-tailedp vdue
@ c .OS) at the 5% Ievel ofsign.i.fïcance.
To facilitate the analysis of device preference, data were organized on the basis of
demographic charactenstics. For example, gender, oxthopedic condition, location of
home, age, height and weight were each divided into dichotomous gmupings. A Fisher
Exact test was then conducted on each paired characteristic coupled with device
preference data using a 2 X 2 contingency table. Significant p-values indicated an
association between the variables. This test is useful for mal1 sample sizes (<20}, which
are otherwise insufficieut for use of the Chi-squared test (Riffenburgh, 1999). Results
were considered significant using a one-tailed p-value @ e .OS) at the 5% level of
significance.
----- m R 4 ; RESWETS
4.1 Deviations from Original Methodology
There were a few adjustments made to the methodology by the researcher based on
severai problems that occurred at the beginning of &ta collection. First, due to funding
problems at CanadaLeg, Inc, the original number of KFC devices that were received by
the researcher was reduced to S. Second, the number of subjects who actudly met the
inclusion cntena for this study was low, despite the assistance of six hospitals within a
three-hour driving radius of San Salvador. Since the war ended, the number of people
with a TTA and injuries to the lower lirnb has drastically decreased. Third, aithough the
hospital sta f f was initially very receptive to the innovative design of the HFC and to the
concept of research on its acceptance and function, they required foiiow-up personal
visits and constant reminders that the recruitment of subjects was an ongoing process.
During this time frame, several potentid subjects had passed through the hospital or clhic
and the lack of phones and transportation to rural areas made recruitment and follow-up
visits very d i a d t . For example, only with the assistance of a person well known to one
partidar subject and an ambulance driver, was the location of the subject in a remote
area detemiined Unfortunately+ a i i other cases outside of urban locations could not be
foilowed.
The forth obstacle to obtainuig subjects was a combination of several t h e
consuming factors. Travel by pubüc transporfation w i t b Et Salvador is extremely slow
due to poor road conditions, repeated breakdowns, and the practice of mahg fkpent
stops to pick up local persons at any time on the side of the road. It couid take as long as
three and a half hours to travel a mere 100 km. However, one of the purposes of this
s m c i p m t a e ~ a n a r b a n a s w c i t - a s a & ~ d a d n y ' s w & o f ~ &
was sometimes necessary for the gait training or testing of ody one subject Furthemore,
the schedde of the translator occasionally needed to be accommodated. In order to
maintain consistency in the test administration, it was essentid that oniy one translator be
used Also, finding another trained translater who was able to devote many houn of
work at a reasonable rate was not easy. Another the-limithg factor was that subjects in
the hospital who began gait training with the KFC were sometimes held in the hospital
longer than expected. Physiciaos were offen difficult to contact and their communication
to other memben of the health care team was very lirnited, rnaking actual dates of
discharge difficult to determine.
The above-mentioned problem led to three changes in the methodology that werr
necessary for the successful completion of this study within the scheduled time m e
within El Salvador:
1. Subject numbers were decreased h m 30 to 22 (one additional subject completed
testing on the HFC only). The decrease in sarnple size resulted in a decrease in
power h m 60% to 50%, meaning there wodd be less chance that the nul1
hypothesis would be rejected when it is actudly faise.
2. The trial period for each device was decreased h m 2 weeks to 10 days.
3. Subject inclusion criteria were expanded to include those who had used ACs
previously for their current condition. In these particulas cases, randomixation of
the subjects to a device was not possible. In ntch instances, subjects using ACs
for 10 days or more were tested on the initial &y of contact with the researcher
and did not continue with the ACs. They were then issued a HFC for a tO-day
4zm*8nfS
There were a total of 27 subjects who met the inclusiodexclusion criteria for this
study, 4 of whom did not participate and one of who agreed to participate then later
withdrew 6om the study. Two of the people who a p e d to take part in the study lived
either in remote ador dangerous areas of El Salvador, and could not participate. One
23-year-old male with an ankle fracture refused participation in the study because of the
heaviness of the HFC in combination with Es cast. The forch person to decline was a 68
year-old small-stature woman who had a great fear of falling and complained of pain at
her tibia1 tuberosity when using the HFC. The one subject who withdrew fkom the study
had completed the 10 day triai and testing with the WC, then reîused to try using ACs
after recalling a fdl he had while using them during a physiotherapy session in the
hospital. As a result, statistical cornparisons beiween the HFC and ACs were made ushg
only the 22 subjects who completed bot& triai periods. The qualitative Somation
gathered about the use of the HFC included the responses of al1 23 subjects. This
information was valuable in identifjmg the reasons for use and non-use of the HFC.
Dernographic characteristics for each subject were collected on Part 1 of the LEAD-A
(Appendix G). A summary of these characteristics is outlined in Table 3.
Table 3 Sobject Demopaphics N/22 Percent NI22 Percent
Gender fernale: 9 39% male: 13 61%
Home Location d: 8 35% urban: 14 65%
LE fractarelamp. amp.: 9 43% hcture: 13 57%
Mean age * std.dev 44.3 h f 6.8 yrs
ciifferences between subjects among the demographic characteristics of age, gender,
injury vs. amputation, location of home, height, and weight (Table 4).
Table 4 Demographic Characteristics Between Groups ln Device Tested
HFC ACs p < .O5 *ge 50.8 k 12.6 years 42.2 * 17.0 years NS (0.18) (meanf std-dev.) Heigh t 162.5 * 10.7 cm 160.4 * 9. 1 cm NS 0.6 1) Weight 65.0 * 9.5 kg 62.5 * 132 kg NS (0.6 1) Gender m4, f-4 m=8, f-5 NS (1.0) Home location urban=8, rural=2 urban=7, rurai4 NS (0.47) Fracture vs. T'TA Facture=6, TTA=4 fiacture=7, n A = 6 NS (1 .O)
Of the 22 subjects who evaluated the HFC and ACs, there were 13 who had been
using ACs pnor to the initial contact with the researcher (Appendbc G). Two nibjects had
used ACs for 10 days post injuryfarnputation. Seven of these subjects had been using
ACs between 11 and 20 days post injury or amputation. Four subjects had been using
ACs between 21 and 30 days. Two nibjects had been using AC for over 3 1 days. Each
of these subjects was tested on the initiai day of contact with the researcher. The
remaining 10 subjects were issued a HFC as their first device tested.
4.3 Usage of Device
The number of days in which subjects reported ushg the HFC and ACs werr
significantiy different @< -05). However, the number of reported hours used per day was
not signifïcantly different between the two groups e .06 ) . Resdts are shown in Table 5.
- pp - - -
Mean f Standard p COS Deviation
Days: Using BFC 7.7 k 2.9 Using ACs 9.7 f. 1.3 .002*
Hours per day: Using W C 2.6 f 1.3 Using ACs 3.0 I 1.2
'NS=not signifiant at the chosen aIpha level of .OS.
4.4 Level of Dimculty
The Wilcoxon Signed Rank test was used to determine the probability of obtaining a
higher median rating among paired data of the HFC versus ACs. The ranks order used in
this section were: did not attempt (O), attempted but unable (1), very difficult (2),
moderately diacult (3), and no problems (4). Results are summarized in Table 6.
The reported n value excludes subjects who did not actually attempt the activity
(score of O). The one-tailed pvalues relate to the probability of a higher median value for
the HFC. For the items of walking quickly and going up and d o m rarnps, subjects
reported using the HFC as being less difficult than when using ACs. The smngest trends
were seen among the items of walking on uneven ground and getting on and off a toilet,
indicating uiat ACs were l e s difncult than the HFC. In addition, items of walking
slowly, going up and down stairs, and getting in and out of a car, resulted in one-tailed
p-values relating to the probabiiity of a higher median value for ACs.
ResuIts indicate that of the 10 hctional items listed in Table 6, the median rating
of the HFC was not statisticaliy different at the chosen alpha Ievel @=.OS) h m that of
ACs,
Device n (excladhg Median Mean Standard Scores of O) Deviation p c .OS8
WakSlow HFC 22 4 3.73 0.50 ACs 22 4 3 -82 0.55 NS (.26)
WdkFast HFC 17 4 3.29 0.92 ACs 17 4 325 1 .O7 NS (.37)
Up Stairs W C 12 3 2.92 1 .O0 ACs 12 3 3.12 0.78 NS (.21)
DownStairs HFC 12 3 2.83 0.83 ACs 12 3 2.94 0.66 NS (.2 1)
UpRamp HFC 15 4 3 -60 0.63 ACs 15 4 3.53 0.70 NS (.35)
DownRamp HFC 14 4 3.60 0.63 ACs 14 4 3.50 0.79 N S (. 1 6)
Uneven HFC 16 3 3.19 0.98 Ground ACs 16 4 3.47 0.90 NS (. LU)
OdOffBus HFC 1 - - hfficient ACs 1 ~ a t a ~
WOutCar HFC 8 3 2.80 0.79 ACs 8 3 3.20 0.62 NS (-08)
OdOff Chair HFC 21 4 3.43 0.74 ACs 21 4 3 -45 0.75 NS (.3 1)
On/Off Toilet HFC 7 3 3-00 0.72 ACs 7 4 3 -63 1 .O0 NS (.O91
'NS-aot signincant at the chosen alpha level of -05. oniy one subject had attempted to use the bus with both ACs and the HFC. This
statisticd test ody andyzes the diffemces in ranks for paved fhctional items in which the same subjects gave a rank using both the HFC and ACs.
A Wilcoxon Signed Ranks test was used to detemillie the probability of a higher
rnedian rating on subjects' levels of satisfàction with the HFC vernis ACs. The rank
order used for his section was as follows: not at al1 satisfied (O), moderately satisfied (1)'
very satisfied (2) completely satisfied These results are outline in Table 7.
Table 7 Ratings of Level of Satisfaction Between HFC and ACs Device II Median Mean Standard
D eviatio a p < .05' Comfort HFC 22 2.5 2.27 1.20
ACs 22 1 1.50 0.9 1 .O03 *
Appearance HFC 22 3 2.59 1-05 ACs 22 3 2-50 0.96 NS (.34)
Weight HFC 22 3 2.50 1-01 ACs 22 3 2.82 0.80 N S (, 18)
Mode of w m g HFC 22 3 2.27 1 .O3
ACs 22 2 2.05 1-00 NS (-16) 'NS-aot significant at the chosen alpha level of .05.
In ternis of cornfort, subjects gave a statisticdiy higher mean satisfaction rating to the
HFC versus ACs. In addition, trends toward higher satisfaction with the HFC in tems of
device appearance and the mode in which subjects' feit they walked with the device. On
the other han& subjects' perception of the weight of the device (heaviness) indicated a
higher trend toward satisfaction with ACs thao with the HFC.
Of these items, only the cornfort rathg reachod statisticai significance at the chosen
alpha level e . 0 5 ) in favour of a higher median rating for the HFC. For the other 3
items, the median rating of the HFC was not statistically significant nom that of ACs.
Subjects reported the approximate percentages of tirne they spent using the HFC and
ACs inside and outside. Pemntages were ranked in 25% increments and each one was
wigned a number h m O to 4 for statistical purposes. Table 8 sununarizes these
Table 8 Percentage of Time Spent With and Without Device Devic n Media Mean Standard P< .O5 e n Deviation
Indoor With HFC 22 2.5 2-32 1.29 ACs 22 4 3 .O5 1.36 .021*
Indoor Without HFC 22 2 1.86 1.2 1 ACs 22 O 0.95 1.36 .008*
OutdoorWith HFC 22 i 1.23 1.51 ACs 22 4 2.95 1.65 .001*
Outdoor W C 22 3 2.64 1.59 Without ACs 22 O 0.86 1-52 .001*
Results of the Wilcoxon Signed Ranks test (shown in Table 8) indicated that subjects
reporthg a change in the median percentage score of t h e spent using the HFC versus
ACs indoors and outdooa, spent significantly Iess t h e using the HFC (pc.05).
4.7 Reasons for Indoor and Outdoor Non-use
Subjects who did not use the HFC or ACs for 100% of their mobility needs indoors
or outdoors, wem asked to identify their reasons for non-use. In terms of indoor use,
there were 5 subjects who used the HFC and 7 subjects who used ACs for 100 % of their
mobility needs. For outdoor us+ there were 4 nibjects who used the HFC, and 9 subjects
who used ACs for 100 % of theu mobility needs. The remaining subjects were asked to
identw ali of their reasons for non-use of the W C and ACs inside and outside. Tables 9
and 10 outline the freqnencies of these reasons.
Reason for HFC Percentage Reasons for AC Percentage non-use of subjects non-use of subjects 1. ktabiiity 54.5 1. htabiiity 27.3 2. hblerns with device 40.9 2. Hands not fke 22.7 3. Other problems 36.4 3. Problems with device 22.7 4. Not fast enough 3 1.8 4. Other problems 13.6 S. Too tirhg 27.3 5. Too Tirhg 13.6 6. ProbIems with 6. Not fast enough 9.1
unaffected leg 22.7 7. Problems with 7. Device needed unaected Ieg O
adjustment 18.2 8. Device needed 8. Hands not fke O adjustment O
Higher percentages for the HFC group in Table 9 result from more subjects
reporthg multiple reasons for non-use of the HFC than for ACs. Consequently, an
ordered List of Rasons was included for purposes of cornparison. Instability was reported
to be the number one reason for non-use of both devices, with a greater nurnber of
subjects concemed with the instability of the HFC than with ACs. The problems caused
by the device were another important issue detemined by the use of the HFC and ACs.
The fact that ACs did not allow subjects' han& to be fke was the second highest reason
for non-use of ACs. As expected, users of HFC did not once report this reason. Users of
the HFC did not consider it to be fast enough, whereas users of ACs did not consider this
to be a major problem. Al1 other reasons (Le. other problems, too tiring, problems with
unaEected Ieg, and device needed adjusting) indicated a similar order with respect to
causa for non-use among users of the HFC and users of ACs.
able 10 Subject Reasons for outdoor Non-Üseof m C and ACs
1. uistability 50.0 2. Other problem 40.9 3, Too tiring 40.9 4. Not fast enough 40.9 S. Problems with
device 22.7 6. Problems with
unaffected leg 9.1
Reason for HFC Percentage of Reasons for AC Percentage of non-use subjects non-use Subjects
Instability 22.7 Other problems 183 Too tiring 18.2 Not fast enough 9.1 Problems with device 4.5 Problems with unaf5ected leg O
7. Handsnot fiee O 7. Handsnot fiee O
Compared to indoor use, subjects reporting on the HFC and ACs use outdoor
resulted in a closer appnximation in the order of importance of reasons for non-use
between the two devices. Again, multiple reasons were given for outdoor non-use of the
HFC versus only one or two reasons for outdoor non-use of ACs. As with indoor use,
instability of the HFC and ACs wau coasidaed to be the number one reason for non-use
outdoors. Note that subjects becarne more concerned with the speed of waiking, their
level of fatigue, and other problerns relating to the W C outdoor use than they were with
a c d device problems. Another interesting finclhg was that subjects using ACs outdoon
were not concerned with the fact that their han& were not fkee. In tenns of other reasons
for non-use, there were no major devïatïons o f trie oder of ùnportance between indoor
and outdoor use of the KFC and ACs.
Subjects were invited to elaborate on their reasons for not using the HFC. Some
of theu comments related to subjects' dissatisfaction with certain aspects of the device
design. Ten subjects cornplainecl that the foot piece was too smdl and appeared to be
unstable which increased their fear of Iosing their balance and fdling. Six subjects
thought the HFC was too time coBsuming to don and doff. Four subjects felt that the
devieeww t~eumbersome- a n c C ~ ~ & e w a ) c - w h e ~ b y - w e ~ e ayiag ta movc u d
inside thev srnail homes. Two subjects believed that the straps and buckles were too hard
and uncornfortable and caused skin irritation while wearing shorts.
Some of the other reasons for HFC non-use given by subjects were related to
cultural and envimumentai factors. Several subjects believed the land in niral areas was
too unpredictable with many potholes, causing them to be fearfbl of falling. A few of the
women users complained of not being able to Wear a skirt while using the HFC. Another
issue was a 6-week rest period that was often ordered by the orthopedic surgeon after
surgery. Theoretidly, this penod was believed to assist with the heding process.
However, this restricted activity Ievel greatly reduced the amount of time subjects could
spend getting accustomed to the HFC. These subjects usudly opted for grabbing a
nearby AC or hopped on one leg for the sake of expedience during liniited activity, such
as getting to the batbmom or getting dressed. In addition, three subjects mentioned that
they felt self-comcious using such an innovative device outside. They felt they were
being stand at and preferred to confine use of the W C to indoors only.
One man, who had a history of intermittent back pain, complained of an
aggravation of his pain every Mie he used the HFC for periods longer than haif an hour
without rest. For this reason, his use of the HFC was limited.
4.8 W C Device Preference
Of the 22 subjects who evaiuated both the HFC and ACs, there were 7 who
preferred the HFC and 15 subjects who prefemd ACs overall. Al1 of the subjects were
asked to comment on why they preferred one device to the other. They were also asked
t e e o m & useofIIF€ &A€sduringthee-seIfiepOaee &&y a&kitks
and three self-reported leisurely activities (Appendix E).
4.8.1 Free Use of Bands
Many of the subjects identified lying in a hammock as one of their three favorite
leisure activities. In some cases, the hammock was used as a bed and getting in and out
was actually a necessary activity. Three subjects felt that the W C facilitated getting in
and out of the hmmock because their hands were free to stabilize its edge.
Two subjects stated they prefemd the HFC so that they could have their han&
fne to do housework. Another subject stated that use of the HFC allowed subjects the
&dom to carry a baby around the house rather than relying on a relative to take care of
the baby.
4.8.2 Equal Weight Bearing
Four of the subjects, who preferred the overall use of the HFC, stated they liked
the ability to stand with an even weight distribution through both legs during their
identified activities. One man with a TTA, commented that it feIt more natural for him to
bear weight through the HFC rather than have an empty spce below his amputated leg,
which is what he experienced as when he walked with ACs. Two of the women
mentioned that it was necessary for them to stand for hours at an outdoor washbasin as
they washed clothes and dishes with their hands. m e n using ACs, the unaffected leg
wodd get very tired as it was forced to bear ail of the weight. Use of the HFC allowed
them to comfortably shift their weight to either the Sected or the unaffected leg.
4.83Earty~k~imWbrn8IICt6ait'Raimng
One young male subject was first seen in an acute stage post surgery at the hospital
after hcturing al1 5 metatarsals. He was unable to get up to wak in the parailei bars due
to extreme pain when his foot was in the dependent position. This subject was pleased
with his initiai use of the HFC because it allowed him to elevate his foot and begin gait
naining earlier than possible if using ACs. Two subjects with trans-tibia1 amputations
were waituig to gather enough fiuids to purehase a prosthesis. In the interim, they both
felt they codd practice gait training in a more normal manner with the HFC than with
ACs.
4.8.4 Combination of the HFC and AC Use
Three subjects mentioned they would use ACs to get to their destination with a
fmily rnernber carrying the HFC. Once at their destination, they would don the HFC so
that they could work and use their han&. Another subject said he prefemd the HFC for
gait training, but used ACs for general mobility. Three subjects preferred to use one AC
in addition to the HFC in order to gain stability. However, two of these subjects said that
with more t h e md practice, they wodd no longer need the AC, which would effectively
fke up both han& when using the HFC.
4.9 Functionai Performance
The fiinctional performance of both the HFC and ACs was determineci using the
LEADP. an objective measure scored by the reseafcher. Scores ranged h m O, subject
did not complete task; to 4, subject completed task without difficuities (Appendix C).
The Wilcoxon Signed Rank Test was used to determine whether use of the KFC resulted
in higher median hctional scores than use of ACs. hie to an unforeseen lack of
enWo-&&*' k w e s ~ & w & y s ~ i b l ô t*bese&L oc €he heiteEn!& iistdon b
LEAD-P. The hctional items of: going up and down stairs; walkùig on an incline4
uneven terrain; and waiking over wet and muddy terrain or an area of d l , dense grass,
were not always able to be tested. A s a result, the number of subjects listed for these
items in Table I I reflects this decrease. However, once the number of subjects with the
same score using both the HFC and ACs were removed as required by the Wilcoxon test,
only one item (walking over wet and muddy terrain or an area of tall, dense grass) did not
have enough data for a meanin@ resuit. Al1 other results of the LEAD-P are outlined in
Table 1 1.
Subjects using the HFC scored significantly highet w.05) than when they were
using ACs on three functional items: 'Carry a glas of water 5 meters inside
how'@=.00); 'Open door, waik through doorway, then close door' e.04) ; and 'Reach
one hand over head while maintahhg good standing balance (as if nding a bus)' w.03).
Subjects using ACs scored significantiy higher on ody one fiinctional item: 'Step
up and down a curb' e . 0 3 ) . Results h m the remahhg 4 functional items niggested
that the use of ACs resulted in a slightly higher Ievel of function in these particular areas.
These items included the following: 'Move k m a standing to sittuig position and h m a
sitting to standing position on a chair without amirests' e.06) ; 'Go up and d o m 5 stairs
without a hancirail' w.24); 'Wak up and down a IOm uneven surface' @28); and
'Staaing in a standing position, bend down to floor and pick up a coin. R e m to
standing position' @--22).
Table l ï Overd Scores on the L%m-P using-ËFC and ACs
Device n Median Meaa Standard Deviation p < .OSa
Sit-stand HFC 22 3 .O 3 .O9 1 .O2 ACs 22 4.0 3.59 .85 NS (.06)
Up/down curb HFC 22 3 .O 2-86 1.25 ACs 22 4.0 3.50 .86 .03*
Carry g las of HFC 22 4.0 3.14 1.25 water ACs 22 2.0 1.73 -83 .OO*
HFC 18 4.0 2.33 .9 1 Up/down stairs ACs 18 3.0 2.50 .79 NS (-24)
HFC 20 4.0 3.15 1 .O4 Uneven terrain ACs 20 4.0 3.45 -89 NS (.28)
HFC 6 - - insufficient Wevmuddy terrain ACs 6 Data
HFC 22 4.0 3 -45 1 .O6 Opew'throughdoor ACs 22 4.0 336 .90 .04*
HFC 22 4.0 3.59 1 .O 1 Armabove head ACs 22 4.0 3.41 1 .O 1 .03*
HFC 22 3.0 2.77 1-23 Pick up coin ACs 22 3 .O 3.14 -89 N S (22)
a NS = Not Significant at chosen alpha level @=-OS)
4.10 Trends Related to Device Preference
Overail prefemce for the WC was 7 out of 22 subjects.
Overall preference for ACs was 15 out of 22 nibjects.
Demopphic characteristics and order of device teshg were identifiai between
both preference groups. The Fisher Exact Test was used to analyze any dinerences in the
proportions of the dichotomous subgroups (e-g. men and women) that fàiI into one of two
- c h s d k h r s (cg* przfcrenet f i Che HF€ or A€* Ç H m rhe 58mpk size of eaeh
subgroup was less than 20 and the expected cell value for each ce11 was less thm 5, the
more comrnonly used Chi-square test was inappropriate. One of the limitations of the
Fisher Exact Test is that it may be too consemative and it is less Iikely to reject the nuli
hypothesis (Pet 1997). For this ceason, any pairs that did not reach statiçtical differences
were closely exarnined for trends that might have been present.
Relatioaships between demographic subgroups and order of device testing to
subject preference for the HFC versus ACs are outiined in Table 12. These results do not
indicate any strong trends towards preferences of the HFC. There were however, varying
degree of trends that were in favor of the use of ACs. The strongest trends towards ACs
preference were seen arnong subjects associated with the following variables: a trans-
tibia1 amputation; trial of the HFC h t ; f?om a rural ara; and above the average height of
an El Salvadoran (1.7m). Subjects living in an ruban area and subjects who were below
1.7 m in height indicated a moderate trend towards ACs use. Subjects with an ankle or
foot hcture, and subjects who-had evaiuated ACs f'ht demonstrated the weakest level of
ACs preference.
HFC (%) ACs (%) p < .05' Fracture n= 13 6 (46) 7 (54)
AC l n n=13 6 (46) 7 (54) HFC lSt n=9 1 (11) 8 (89) NS (. 10)
Urban area n= 14 5 (36) 9 (64) Rural area n=8 2 (25) 6 (75) NS (.49)
Height < 1.7 m n=16 6 (38) 10 (63) > 1.7m n=6 1 (17) 5 (83) NS (-35) WS = Not Significant at the chosen alpha level @-.OS)
4.11 Trends Related to Satisfaction with Device Characteristics
Instability was identined as the number one remon for the W C non-use, thus
certain demogmphic nibsea were andyzed in order to detennine which gmup was most
likely to report instability. In each audysis, mbjects' perception of instability during
outdoor use of the device was analyzed in relation to demographic subsets. The Fisher
Exact Test was used and these results are summarized in Table 13.
amputation group. Subjects with an amputation were more likely than those with a
hcnire to reject the HFC (89% vs. 54%, fiom Table 12) due to reasons of instability
(78% vs, 38%' h m Table 13). A moderate trend relatmg to instability data and the
location of subjects' homes was also consistent with the results from Table 12. Subjects
h m a rurai area were more Iikely to reject the HFC for misons of instability (63 %) than
nibjects h m an inban area (43 %).
statistically related to any of the following demographic characteristics: orthopedic
condition (p=.08); testing order of devices @=.50), home location (p=.33), and height
Table 13 Demographic Subsets in Relation to Perceived Instability
Subject BFC InstabiIitv Characteristics Yes No p < .OS8 Fracture n= 1 3 8 (62)
ACs 1" n=13 6 (46) KïC 1" n=9 5 (38)
Urban area n= 14 6 (43) Rural area n=8 5 (63)
Height <1.7rn n=16 8(50) 8 (50) - > 1.7 m n=6 3 (50) 3 (50) N S (.68)
%S = Not Signincant at the chosen alpha l e d @-.O%
Table 14 displays the dimensions of appearance and perceived heaviness among the
hcture vs. T'T'A subsets. There was a possibility that subjects with a fracture would be
using an ambulatory device for ody short-terrn use and would be less likely to report an
unsatisfactory appearance of the HFC. On the other hand, subjects with an amputation
mqUiRd the long-term use of an ambulatory ai& and its appearance Mght have been a
major reason for non-use. There was also a possibility that subjects with a hchire and
the additional weight of a cast would perceive the HFC to be heavier than would an
amputee. In order to meet the dichotomous data requirements for the Fisher Exact Test,
ratings for subject satisfaction with appearance and heaviness were collapsed h m 4
categories to 2. The ratings of 'wt at d satidied' and 'moderately satisfied' were
grouped into one category and ratiags of 'very satisfied' and 'completely satisfied' were
Table 14 Relation of Fracture vs. TTA to HFC Heaviness & Appearance HFC Appearancea Perceived Heavinessa (unsatisfied) (%) (unsatisfied) (%)
Fracture n=13 1 (8) 3 (23)
D value -17 -68 Includes 2 ranks: Not Satisfied, Moderately Satisfied
Subjects with an amputation were generally Iess satisfied with the appearance of
the HFC than subjects with a fracture. Subjects with a hcture and the additional weight
of a cast did not indicate any differences in satisfaction ratings of the HFC when
compared to nibjects with an amputation. Note that within the two groups of subjects,
the percentages in terms of king unsatisfied with EIFC appearance and beavhess were
relatively low, thus a Iarger group of satisfied subjects under both conditions was evident.
4.12 User Recommendations
Although a question relating to recommendations for change of the HFC was not
inchded in the questionnaire, many subjects initiated their own suggestions for
irnprovements that might increase their acceptance of the device. Since the subject
responses were traaslated h m Spanish, verbath quotes were not possible. As a result, a
paraphrased, translated l ia of recommendations is summarized below.
For subjects with a TT& a shorter tiiiai tray would allow them more fkedorn to
move in mal1 spaces.
Increasing the sufice area on the fmt piece to be similar to the size of a nonnd
foot wodd increase stability.
~ t h c f m p i n r f f e t d & e h r m o r e a a b t t w h ~ g o v e ~
and muddy terrain
Making the beam longer so that when people hold onto it for stability, they can
grasp around it rather than holding on top, which caused pain in the pdm of the
hand. This point was made under the assurnption that the user would not need to
bend over while wearing the device (i.e. take the HFC off prior to sitting).
Adding a hinge to the beam would mate it unnecessary to take the device odoff
to sitktand, especidly within s d l spaces like the bathroom and car.
Using a lighter material would decrease fatigue when using the WC, especially if
one has the weight of a cast as well.
Using a softer, more pliable material for the straps and buckles would reduce skin
irritation and increased pressure.
Making the device easier to get on and off would mean another person would not
need to assist in this task.
Developing a simple training program would d o w people to practice walking at
home and decrease the time required to leam how to wallc with the HFC
Do not let people with pre-existing back pain use it since pain will be agpvated
with the use of the HFC.
- - eEbPl3R 5; DISEVSSf €HF
This study explored the dimensions of acceptability and function with respect to the
use of the HFC versus ACs. The original hypothesis as stated in section 1.3 was not
entirely supported by this study. However, subject satisfaction regarding device comfort
and three items on the functional test did reach statistical significance and were in favour
of the HFC. The areas in favour of ACs were those of device usage and one item on the
fun&onal test. The nul1 hypothesis could not be rejected for d l other items on the
questionnaire and the functional test. That is, there were no differences between the HFC
and AC with respect to device acceptance and subjects' functional abilities. Overall
preference for a mobility device was in favour of ACs.
Although the data in the cumnt midy met ail of the assumptions of the Wilcoxon
Signed Rank Test, the relatively smail sarnple size affiected the sensitivity of this test,
with power being set at only 50%. Actual differences between the HFC and ACs use may
not have been detected, d t i n g in a faIse conclusion that there were no dineremes.
Nonetheless, it was worthwhile to consider even the smail differences between the two
groups under the assumption that had the sarnple been larger, an adequate level of
signincance might have been achieved
In an attempt to understand the lack of preference for the HFC in El Salvador,
issues relatexi to functional abilities while using the HFC, the environmenail context of
developing corntries as well as culturat and social factors are examined.
5.1 Functional Abilities in Using the HFC
In a omnber of funcitonai areas, ACs were p r e f d over HFC. Physiological,
biomechanid, cornfort, and learning fkctors may have contri'buted to this preference.
Several studies relating to energy costs and speed of walking with ACs were
examined to help explai. subjects' overall preference for ACs. There is good evidence
that the energy costs of ambulation are minimized when subjects select their own speed
(Mayhew, 1977). It has been show that walking with ACs results in significantly lower
self-selected walking speeds than during normal w a b g (Holder et al., 1993; Bhambani
& Clarckson, 1989; Goh et al., 1986). When focceci tu walk at high speeds using ACs,
the physiological stress that is attained is comparable to that of m i n g at a moderate
pace (Bhambani & Clarkson, 1989).
in the curent study, subjects felt that walking slowly with the HFC was more
ciifficuit than with AC (Section 4.4). However, subjects felt that waiking at fast speeds
with HFC was easier than with ACs. Thus, subjects' perceived level of exertion caused
by walking quickly was much higher with ACs than when using the HFC. At lower
levels of exertioa, such as d u h g slow waiking, there was an increased acceptance of
ACs. One of the benefits of the HFC over ACs during strenuous activity, nich as fast
walking, are its lower energy CO-.
Going up and down stairs was also found to be easier with ACs, while ramp
climbing was easier using the HFC. These findings may have been a reflection of the
diffe~nces in physiological costs rrquirrd to perfonn each of these tasks with different
devices. Severai subjexts commenteci that ramp walking with ACs caused an inmaseci
level of fatigue when compared to the KFC. Fisher and Patterson (198 1) found that stair
climbing with ACs required Iess aiergy expenditure per height gained than ramp
*. hrcbenment* sabjcc& usmgW€cnramps wereapparnittg.
experiencing an energy expenditure that was the reverse of that found with ACs.
Reliminary explmations for these hdings conceming the HFC follow the sarne
basic principles of kuiematics and energy requirements as in using a BK prosthesis. That
is, with the HFC there is limited assistance given by the upper body and the device must
move in unison with the affected leg, simulating a normal gait pattern. in a preliminary
investigation of the mechanical energy expenditure (MEE) of the HFC, it was discovered
that the MEE when using the HFC is closer to that of normal waiking than the MEE
during swing through gait using ACs (Borkhoff, 200 1). An examination of physiological
information fiom previous studies investigating the use of BK prostheses on stairs could
help clarify results of the m e n t study since the HFC mimics the essentiai characteristics
of a BK prosthesis. Datta and colleagues (1974) investigated stair climbing by below
h e e amputees using either a BK prosthesis or ACs. These authors found that subjects
using the ACs required 28% more energy than those using a prosthesis. if use of the
HFC parallels the level of fatigue in using a BK prosthesis, then stair w a h g with the
HFC shouid not have been reported to be as diacult as it was in the current study. The
HFC may not be as efficient a device as a BK prosthesis due to weight and fit
considerations.
Nonetheless, the physioIogicaI and functional importance of allowing patients to
begin at least partial weight bearing through their amputated or firactuml Ieg as soon as
possibIe has been well established in the literantrr (Lindsjo U, 1985; Pinnir et al., 1988).
Waters and coUeagues (1982) reported a 66% increase in energy expenditure and a 48%
increase in heart rate with non-weight bearing ambdation while wearing a LE cast and
usïng ACS whm compareci with full weight-bearllig wearing a LE cast and using ACs.
- -- b b a m m e ~ttbjem wmg(htHF€ wite rtnimkleor fwt k t ~ e were able te
maintain their non-weight bearing status at the afkcted joint, while simultaneously
beginnuig to weight-bear through the tibia1 tuberosity via the device. This early r e m to
weight bearing rnay have energy-sparing benefits to those with these conditions.
5.1.2 Biomechanics of W C Gait
Observations of subjects during the initial stages of gait training with both the
HFC and ACs indicated a common proteetive flexed posture of the mink due to feelings
of instability. Individuals who feel as though they may lose their balance will normally
try to increase theu stability by flexing at their ûunk, hips, and knees, thereby bringing
their centre of gravity lower to the p u n d with a slight crouch (OYSullivan & Schmitz,
2001). The design of ACs is such that it allows for a stightiy flexed posture, with little
effect on stability due to the three-point support. Tbus, subjects demonstrating this
posture had few difficdties with ACs gait Uaining. On the other hand, the design of the
HFC dictates that any flexion at the mink and lower extremities works biomechanically
against the critical need to maintain extension at the hip and relax the knee flexoa of the
affected leg to maintain stability. During the course of this study, it was observed that
subjects who were being trained to use the HFC required many more verbal cues to
maintain an erect posture during gait training than subjects using ACs. A further reason
for inmaseci verbal cues and feelings of instability with the HFC in El Salvador may
relate to the hct that the HFC was onginally tested and designed for a population with
lower extremity injuries, not amputations. An dtered centre of mass arnong subjects with
a ïTA rnay require m e r biomechanid investigations to determine the appropriate
pitioniageEthd4FC f6ot-pieeearwCkegcBof thea'biactrayfo~ thispopulat ioata~w
them to maintain stability.
Subjects dso reported that going up and d o m stairs with the HFC was more
dinicult than when using ACs. Dalton and colleagues (2001) found similar difficulties
with the use of the HFC during stair climbing in a Canadian population. There are
several possible explmations for this result in the cumnt study. First, assuming the=
was no handrail, subjects using ACs could have used either two catch tips or the foot
h m the unafFected side on the ground as the supporting d a c e , leading to increased
stability. Second, even with the presence of a handrail, stair climbing would be easier
for subjects' ushg ACs. They would have the advantage of being able to balance on
one foot while using both ACs in one hand with the rail in the other hand and hop up or
down the stairs. For the E-IFC users, whether there was a hand.mil or not, instability
would have been especially apparent once subjects were forced to place al1 of their
weight on theü af'fected leg while a transition between heights was made.
Higher satisfaction with the HFC in relation to the marner in which subjects
walked was partly due to the achievement of a more syrnmetrical waiking pattern when
compared to that achieved with ACs. HFC use allowed a more even weight distriiution
though both the affected and non-affected legs as opposed to use of ACs and walking on
only one leg. Revious research by Stallard and colleagues (1978) found a 25% i n m e
in vertical force for the imaffected single-leg landing during stance phase while non-
weight bearbg and ushg ACs, when compared to normal wallring. Although subjects
h m the c u m t snidy did not report any particular problerns with the unafEected leg
during ACs walking a more even weight distn'bution could be one of the potential
benefits of using the HFC. Persons with acisting mild weakness or disease pmcess of the
- &iteQleg, ~1&e606teOLIFfhFi@ msybeabht~&aiwelief by using the affer:
an injury or amputation. This could be M e r exploreci in foilow-up studies.
Another possible reason for subjects' satisfaction with the HFC with respect to their
waiking pattern was the forced upright position that was necessary to walk, as previously
stated. In order to effectively step forward while maintainhg balance, subjects were
forced to maintain full hip extension during the stance phase on either the dfected or non-
affecteci leg. With ACs use, the centre of gravity must be effectively brought f o m d to a
point between the placements of the two crutches to complete one gait cycle (Shoup,
1974). In a recent study, Li and colleagues (2001) reported on the bernatic
characteristics of 10 %, 50%, and 90% partial weight-bearing gait using ACs. In each
case, the centre of gravity shifted slightiy fkom the affected leg to the non-afFected leg and
ruovement pattern changes were evident. The muik and pelvis on both sides were
rnaintained in a forward lean position, resulting in decreased lateral and rotationai
movernents at the trunk and pelvis. Full hip extension could not be achieved due to the
forward tilt of the pelvis. As the percentage of weight bearing increased, the position of
the joint angles approached normal values. Although the authors of this study did not
examine non-weight bearing joint angles, it could be assurneci that each angle would be
increased over a situation of 10% weight bearing as subjects tried to clear their affected
leg from the ground. When using the HFC, subjects have the benefit of maintainhg a
completely upright tnmk and a neutral pelvic position during non-weight or partial
weight-beaxkg conditions. The pelvis and muik can fkely rotate and the hip can reach
fidi extension at terminal stance as chrring normal walking.
Weight-bearing charactexistics of the HFC, o c c ~ g partiaiiy through the di&
pateiIa and the patellar tendon are s M a r to those of the patellar tendon bearing
prosthesis or eask There is substantittk e v i d e w e w i ~ t k lit-e rehhg t e t8e
benefits of each of these designs (Ahmad et al., 1989; P k et aL, 1988; Boot & Young,
1985; Tibarewala & Ganguli, 1982). Some of these benefits include early mobilization;
fewer days spent in hospital; and decreased loading on the fhcture site. Although these
variables were not examined within this study, m e r investigations fiom this
perspective could lend additional support to the benefits of WC.
5.13 Comfort Related tu Function
In contnist to limitations of the HFC design fkom physiological and
biomechanical perspectives, subjects were more satisfied with the HFC in the m a of
cornfort. Cornplaints of increased muscle soreness of the upper extremities and pain
through the axilla and hand, resulted in low satisfaction ratings for the comfbrt of ACs, in
cornparison to those for the WC. in contrast to these complaints, many subjects
commented bat their ability to shifi weight from one leg to the other made the W C very
cornfortable. When subjects were using ACs, they complained of hip and knee fiexor
muscle soreness and fatigue on the afFected leg since they were not able to rest the
unafFected leg at any time during standing or ambuiation.
Fifteen of the 22 subjects complained of pain in the axillary region when using ACs.
Due to recruitment methods and time constraints of this study, the researcher could not
always be present during the initial ACs gait training stage for each subject. However, at
the time of foliow-up testing, sabjeas who weE not initially fitted for ACs by the
researcher were meannrd to assure proper finuig of their ACs. In each of these cases,
the ACs met standard timng requirements of approximately two finger-widths below the
axilIa and an angle of between 20 and 30 de- of elbow flexion with han& on the
h a n d p r i p s a n a s ~ r e t s r x & ( W ~ & S ~ 2 W ) DespaeproptrMlmgof
ACs, subjects continued to lean forward and cause pressure and skin irritation in the
axillary area, perhaps to take the weight off the unaffected leg.
Other subjects cornplained of pain due to pressure on the palms of their hands with
ACs. One subject had arthntis in her fingers and use of the ACs caused her increased
pain in this area. Goh and colleagues (1986) found a peak reactioo force of 44.4 %
bodyweight transmitted to the palm of the hand drning AC walking. They also reported
an increase in compression force of 34 % bodyweight in the axillary area if ACs are used
incorrectly. The authors cautioned against the use of ACs among people with weak
upper extremities. Similarly, Shoup and colleagues (1974) drew attention to the large
shock load that is transmitted to the upper extremities as AC tips are planted None of
these problerns occmd with the HFC use.
One particular subject with a foot hcture was very satisfied with the cornfort
provided by HFC. At a time when he was unable to tolerate the use of ACs due to
unbearable pain when his foot was left in a dependent position, the HFC provided the
support he needed. With the use of the HFC, his lower leg remained on the tiiial tray, in
a more elevated position than with ACs use. He was then able to begin early gait
post fmt fracture, which would have otherwise been delayed
AIthough the majorîty of subjects were satisfied with the comfoa of the HFC, there
were three subjects with ankle hctures who cornplained of feling pins and needles fiam
their knee to their ankle once the device was removed. This phenornenon could be
explained by the compression of the tibid nerve as it passes through the popliteai fossa or
at the point where the cast ended, thereby adding pressure to the nerve beneath the
---.. - - g a s t r o c n m i m s d s o t c u s ~ k ~ r h e ~ ~ r r m o ~ & ~ ~ ~ € o t t 1 B b t
extended, temporary paresthesias redted as the compression was relieved.
5.1.4 Training Factors
There was an increased learning period for proper use of the HFC. In a recent pilot
study of the HFC v e n u ACs in Canada, a two-week accommodation period was ailowed
for each device, which may partially explain the larger number of subjects who preferred
the W C (Dalton et ai., 2000). In the current sntdy, although subjects were observed to
demonstrate adequate balance and fuaction while using the HFC during training, they had
difficulty in achieving the requind position of the trunk and lower extremities in order to
reach this level of function. Many subjects noted that they continued to adjust to the HFC
use well into the 10-&y aiai period. One woman with an ankle hcture stated that she
would need at least two weeks of constant use to leam to use the HFC and feel secure, yet
she only needed 3 to 4 days with the use of ACs. Another woman with a TTA worked on
a f m by henelf and felt she would be greatly helped by having her han& free while
using the HFC, but she did not have the time to practice and become cornfortable with the
HFC due to her work priorities. Some subjects indicated fetlings of frustration during the
HFC triai period and were likely to use their own ACs, or find another means of mobility,
for functiond tasks d d g the HFC triai.
53 Environmental Constraints
Environmental conditions within El Salvador often posed several challenges to use of
the HFC. Waiking on uneven terrain, getting up and down fimm a chair without amirests,
and manoeuvring within the bathroorn to get on and off a toilet, were each rated morr
ciiffïdt to perform using the HFC than ACs. Subjects' comments on the instability of
.A- - kW€ the di-ties e 3 1 ~ b ~ ~ o ~ t m e y e ~ l WF& wem smskêent
with this finding. Getting up and down h m a chair was more difficult usuig the HFC,
probably due to the longer time period involved in donning and doning the WC. If the
HFC was left on while trying to sit, there was a fear that one might be forced to bear
weight through the foot of the hctured leg as it was necessarily lowered to the ground
while the knee maintained a flexed position. Dalton and colleagues (2001) aiso reported
subjects' dissatisfaction with the excess tirne requirements to put odtake off the HFC.
Subjects were also required to take the device on and off to avoid hitting the sunoundhg
wdl or blocking space for other people to walk by. In the bathrooms, which are often
very small, subjects reported having difficulty trying to manoeuver in the space that was
available. In nval areas, subjects often used an outhouse where they would have to walk
over uneven terrain and many subjects did not feel secure using the HFC to walk diis
distance. Subjects often complained of feeling unstable with ACs, but stated that
instability was felt to a p a t e r extent with the HFC.
Another problem encountered by some subjects with a short leg cast and using the
HFC was the variability in stair heights in El Salvador compared to the Noah American
standard of 19 cm. When the step height was large, and approximated the distance fiom
the foot piece to the tibia1 tray on the W C beam (Le. the distance h m the foot to the
mid-patella on the unaffecteci leg), subjects had difficulty when stepping down because as
the foot piece of the HFC was placed on the step bebw, the flexed lower leg and foot hit
the step above. Some subjects using the HFC realized that by stepping down sideways,
she flexed lower Ieg and foot could easily clear the step above, but other subjects did not
recognize this solution.
=- -- € k t ~ ~ ~ h€sltsewass&t&tspose-eprobl-d~g tk &yseameh
El Salvador. Two subjects had expenenced AC slippage on wet terrain, and were very
fearful of f a h g under these conditions. They both felt that the mbber tire-like mads on
the foot piece of the HFC would probably preveat any slippage, but unfortunately the wet
season had ended in the early stages of this study and subjects were unable to test this
theory.
53 Cultural and Social Issues within El Salvador
53.1 CulturalIy Speciflc Activities
When asked to i d e n w three necessary and thm leisurely activities, the majority of
tttc subjects who preferred the HFC overail, mentioned activities that required their hands
to be fke. Sorne of the activities mentioned were sirnilar to those found in North
Amencan culture, such as cooking, cleaning, and serving food. This association of the
HFC preference with two-handed activities was M e r demonstrcited by subjects who
scored higher on the LEAD-P while using the HFC for tasks requiring that the han& be
fke (e.g. canyiag a glas of waters openinglclosing a door, reaching one hand over head).
There were also some culturally specific reasons given by subjects who prefemd the
HFC in El Salvador. Some of these reasons were functional, nich as the ease of getting
in and out of a hammock and standing for long penods while washing clothes by hand.
Following the concept of the HFC, the husband of one subject actually built a cernent
block at the outdoor wash basin to ai1ow the subject's amputated leg to rest, while
allowing h a h a . to be fke to wash. The ability to carry a baby while using the HFC
was &O fomd to be very advadageous by two sabjects. In many El Sdvadoran homes,
a hi@ chair, playpen, or stmller is unaffordable. As a result, there is no place for a young
babykFbt @done & ~ w a ) . - & * ~ ~ & & teushg AG's teearry the baby.
Consequently, it is usually necessary for the baby to remain with a relative or close fiiend
during a caregiver's convalescence. One man, who worked as a vendor in a local market,
stated he had much difficulty using ACs and trying to get money in and out of his money
belt in addition to reaching for items in his stall. He always required the assistance of
another peaon, but with the HFC, his han& were fke to do these tasks independently. In
each of these situations, use of the HFC appeared to ailow a higher level of independence
for caregivers and an improved quality of family life.
Some of the women, who had aied the HFC, were not satisfied with the device
because they were unable to Wear a skirt. The skirts wom in El Salvador generally reach
a length just above the knee, which restrict forward and lateral displacements of the thigh,
necessary for fimctional waiking with the WC. In hot weather, women rarely Wear
shorts due tu cultural taboos, so the fact that they were unable to Wear skirts was a real
concem to them.
53.2 Acceptability of Appearance
Cultural acceptability of techaical devices is measured on several dimensions, one
of which is appearance (Medey, 1995; Vos et al., 1993). In El Salvador, just over half
of the subjects accepted and were impressed by the innovative appearance of the HFC.
Sorne abjects were already using ACs that were homemade versions because they could
not a o r d to buy commerd ACs. The HFC provided what was referred to as an
'expensive-Iooking' alternative, which pIeased most subjects. However, some subjects
felt that the appearance of the HFC was too modem for the culture in El Salvador. They
felt that since ACs are the most commonly useci ambuiation device in El Salvador, they
w e r t m t eoateak wi&aq&hp%Berenk k ~ d i b & w m stepoutsidehis borna-
with the HFC, stating that he was self-conscious and did not want to have people stare at
him.
When data were examined accordùig to subgroups, it was detemined that 33 % of
subjects with a 'ITA were unsatisfied with the appeanuice of HFC, while only 8% of
subjects with a hcture were unsatisfied with the appearance. Perhaps the recent change
in body image among subjects with a newly acquired trans-tibial amputation precluded
acceptance of a device that was so obviously different h m other ambulatory devices in
El Salvador. Nevertheless, two of the 9 subjecu with a TTA did prefer the appearance of
the HFC to that of ACs. Both of these subjects commented that their primary reason for
using the HFC was for its appearance, thereby ovemding any of the other potential
benefits or problems with the device. One of these subjects preferred to Save the HFC for
special occasions while using her ACs on a day-to-day basis. The other subject wanted to
use the HFC while he worked as an electncian so that he could look respectable in
clients' homes.
5.33 Role of the Family
Another culturaily specinc reason for subjects prefenîng ACs could be related to
the care-giving role that is often assumed by family members in developing countries
(Ingstad, 1999; Thorbum, 1999). In the current study, some subjects report4 that during
convalescence, almost ail of their daily needs wexe taken over by other family members.
Subjects had aied to carry on with their previous levels of activity, but their families
wodd not permit them to attempt many tasks for fear of their family member falling and
re-injiiring themselves. ConsequentIy, while using the HFC, these subjects did not have
mgily opporttmitieste~edize t k ~ p e t e n ~ & h a v i a g ~ hm& &ee t e attend te&
of their personal needs. Future studies should consider the exclusion of subjects living
with their partner andior family members, which may lead to increased levels of
independence and satisfaction with the HFC.
In addition, many subjects wen iastnicted by their orthopedic surgeon to restrict
their leveis of activity for a full six weeks or longer post injury or amputation to allow
adequate healing. In these cases, family assistaoce became essential. In El Salvador,
there is a strong hierarchy of medical care and the physician holds the highest authority.
Despite physicians' consents to allow t heu patients to fully participate in this study, they
continued to reinforce their standard protocol of rest to patients. Unfortunately, the
researcher was often unaware of this problem until the 10-day triai period had been
completed. Therefore, with sh'ong family support and physicians' ordea to rest, some
subjects did not place a high pnority on having their hands fkee to cesume their daily
needs. Mead, they appeared to prefer the convenience and ease of use of ACs.
e m R a . metvszmmmme~m~mws
6.1 Conclusions
The Hands Free Cmtch (HFC) was developed as an alternative ambulatory aid for
patients who require a period of non-weight bearing. This study assessed the hct ion
and acceptability of the W C in El Salvador by subjects with either a tram-tibia1
amputation or fracture at the foot or ankle. The method by which information was
collected was by a questionnaire and a fiuzctional test developed specificdly for the study.
There were a total of 22 subjects who evaiuated both the HFC and ACs in a
mssover type design, and one subject who evaluated ody the HFC. The mal1 sample
size and resuiting power of only 50% may have Iimited statisticd significance in many
mas of testing. However, where significant values wen not found, trends could be
identified. Even though overall subject preference was not in favor of the HFC, results
point to certain demographic groups who may benefit h m use of the HFC. It should be
noted that subjects spent significantiy fewer days using the HFC during the 10-&y trial
period than using ACs @.002). The reduction in time spent with the HFC was
determined to be during both indoor @=.Ml) and outdoor use of the device (p=.OOi).
This unucpected hding may have had an adverse impact on the use of the HFC in al1
areas examined in this study.
Responses on the LEAD-A questionnaire indicated that subjects were datively
satisfied with the device characteristics of the HFC, but found the HFC use genedly
more diEcult than use of ACs. Of the four device characteristics listed, trends were
identified toward higher satisfaction ratings with the HFC in the areas of appearance of
the device, the way in which the device made subjects wak, and a significantly higher
mtiugktkmnrof d e v i r r d a r ~ f p i M b EwtemwvEdiified~ mhgiusing the
HFC, overall higher ratings were identifieci during the functional activities of waiking
quickly, and going up and d o m ramps. Al1 other functional activities listed on the
LEAD-A were rated easier when using ACs, with the strongest trends seen with wallcing
on uneven terrain and getting on and off a chair and toilet.
The primary reason given by subjects reporting the HFC non-use was found to be
instability. Results on the LEAD-P confinn the fact that subjects are refemng to dynamic
Uistability of the HFC and not static instability. Subjects had significantly more objective
difficulty (p .03) using the HFC while stepping up and down a curb (dynamic
instability), but significaatly Iess diffculty w.03) maintaining balance while
maintaining their arm overhead (static hstability). One subjective comment made by
several subjects relating to dynamic uistability of the HFC included an unpredictability of
the potholes in the gmund and a fear of falling. Analysis of demographic subpups
indicated that subjects with a T'TA were more Iikely to comment on feelings of instability
of the HFC versus subjects with an ankle or foot fcacture.
Other reasons given by subjects with respect to HFC non-use were as follows:
problems with the design of the device (e.g. foot piece too small, tibia1 tray is too long);
inability for women to Wear skira as a cultural nom, chronic back pain, doctor's order
for a pmlonged six week rrst period, and self-consciousness of new device.
Severai reasons identifying the benefits to HFC use were also elicited h m
abjects. They reported the opportunity to bcar weight evedy through both legs so that
the non-Sected leg did not fàtigue, it facilitated the ability to get in and out of a
hammock, eerly opportuoity to waIk, pre-prosthetic training, &es the han& for
housework and to take care of their children,
RCSOffS on the o&c&eEEaOtpZ drmonsatcee (+ h i g k n u n t k of subjee*
reaching levels of statistical sipificame in favor of the HFC. These items included
standing with ann held overhead, bending down to pick up a coin, and opening and
closing a door. Each of these items involved the use of hands, which was more difficult
for usen of ACs. Al1 other items on the LEAD-P were given a higher score in favor of
ACs. Only one of these items reached a level of statistical significance; stepping up and
d o m a curb.
Trends were also identified in demographic characteristics of subjects least likely to
reject the HFC device. These subjects hcluded those who had an ankle or foot bcture,
were nom an d a n area, and were under 1.7m in height On the other hand, subjects
with a trans-tibia1 amputation, and subjects who had evaluated the W C fht,
demonstrated a strong trend against the prefemd use of the HFC.
The majority of subjects in this study did not prefer the HFC. However, once the
recommendations are incorporated hto a aew design of the HFC, its potenhal use within
developing countnes codd be reaIized.
6.2 Limitations of the Study
One of the primary limitations of this study relates to tune restriction for data collection,
which is often found in cross-cultural research, With a limited ntunber of HFC devices, in
addition to the relatively short t h e fiame in which to complete the data collection, the triai
period for subjects to accommodate to using the new device was restricted. It was the
researcher's experience that diaing the training penod, subjects required a longer time to achieve
safe use of the HFC than when they were using ACs. It is possible that a longer accommodation
- pek&wouMkve-pdud more-pit ivetesul~tm&the HF€. A k t k i s p i n ~ theitkakke
fiame in which one can become accustomed to the HFC has yet to be detemiined. However,
subject feedback fiom the current study and results h m a previous pilot study in Canada
indicated that at Ieast 2 weeks of practice would be needed.
One of the findings of this study was that subjects chose to use the HFC for fewer days than
the AC, which may have adversely impacted the resuits of this study. Many subjects aiready had
AC at home and because of their relatively high coa in El Salvador, it would have been unethical
to remove them from subjects' homes for the purposes of this study. They were instead given
strict instructions to avoid any use of AC during the triai period of the HFC. However, these
instructions were not always followed and subjects commented that they would use AC Uistead
of the HFC when getting up for a quick task. On the other hand, subjects did not have an
altemate ambulatory device available during the triai period of ACs, even if they had desired one.
Therefore, the number of days in which subjects used ACs was greater than with HFC during
their respective trial periods. Future methodologies m u t develop ways around this ethical issue,
such as doaating the HFC or a new pair of ACs to each mbject at the completion of the study.
This way, ail alternative ambulatory aids could be removed h m subjects' homes during each
trial period.
Another limitation was the necessity of translation of instructions and nibject data.
The tramlator's d e was to read each question on the LEAD-A in Spanish to the subject
undergohg testin& and then translate aii subject responses into English, which was
audiotaped for later use by the researcher. Durhg the entire subject interview, there was
a constant researcher to transistor and translater to researcher interaction, checking to
assure the a d subject response was recotded As a M e r authenticity check of
subject responses, the researcher's basidintermediate level of Spanish and a monitoring
- - - of ~ ~ o n s Sne ges-oftke=sub* hef@bgivean indht io~ os either
full comprehension or a Iack of understanding on the part of the subject. The back-
translation method by which the questionnaire and hct ional test were developed helped
to decrease any discrepancies in ternis of language. However, despite this rigomus
routine, the mearcher could not always be absolutely certain that the questions were
completely understood by the subject, and errors in ncorded responses may have
resulted.
The vaiidity of the self-reported data in the questionnaire rnay have been limited due
to a 'socially desirable response' bias (Stewart & Ware, 1992). At times, especially with
crossniltural mearch, there is a tendency for subjects to report socially desirable
behaviour and make theu situation seem more favourable than reality dictates. However,
this problem was not strongly evident in the current study since overall results were not in
favour of the original hypothesis. Subjects generally chose the device that was more
familiar to them in their culture rather than attempting to please the researcher by
choosing the HFC. Nevertheless, there may have been some positive responses given for
the HFC regardiess of subjects' a c t d perceptions of the HFC. To partially control this
bias, the objective fimctional data obtained by the LEAD-P was cross-vdidated against
the data h m the ~ e ~ r e p o r t e d responses on the LEAD-A and there were no obvious
inconsistencies found.
As with most midies that are conducted using a sarnple of convenience, the validity
for rnaking inferences amss a variety of climates, environments and c u i t - is luniteci.
Since the data was coilected h m the centrai and western portions of El Salvador, the
d t s do not necasarily apply to the use of the KFC device in other corntries or even
during other seasons witbin El Salvador. AIthough generalizability across seasons was
mtwpct& ittmachemeereher's-in~~toedeek&tgfBt &HF€ duRagbo&W
rainy and the dry seasons withi . El Salvador. However, making contacts and obtaining
subjects was not as timely as anticipated and occurred just as the wet season was ending
(early October). As a rmilt, most of the subjects were tested in the dry season
(November-December).
It should also be recognized tbat the sample that was obtained for this study does not
necessarily represent dl potential candidates for the HFC. This study represents the first
step to evaluathg the device within a developing country. One of the purposes was to
identify a group of potential beneficiaries of the W C and by achieving this goal,
recommendations for changes in design were made.
6 3 Recommendations for Further Research
In addition to being the first evaluation of the HFC in a developing country, this
study was the first to asses the HFC use with subjects having a trans-tiiiai amputation.
At the time of the current study, there had ody been pilot data collected within Canada on
subjects with either an ankle hcture or injury. Consequently, the current study opens up
many more doorways for friture research of the WC.
Rior to commencing M e r research, consideration needs to be given to the
relatively long learning penod required for the HFC should be made. A standardized
training penod could be pmvided in which subjects are first made aware of the increased
t h e conmitment recpired for proper use of the HFC.
The specific design recommendations made in this study codd be applied to future
designs of the HFC. The next version for the HFC should consider: a shorter tibid tray
for people with a TTA; repositioning of the foot piece based on measurements of centre
-- - - of @ty foi. tk pophtiorr, ahinge--the shetktc~clllow s i e g wite &vice; leathe~
straps for increased cornfort; and buckles that are easier to release for independent
donning and doffing the HFC. In addition, hture studies could investigate alternative
materials that are readily available w i t h El Salvador or other develophg counûies. The
director of the prosthetic and orthotic program at the University of Don Bosco, suggested
the use of thermoplastics or even wood as a cost-effective replacement material.
Studies on HFC energy expenditure need to be considered. With the high-energy
consumption and physiological stress that is associated with ACs, an alternative
ambulatory device with proven lower values in this area wouid be welcomed.
Furthemore, with the knee at a constant 90-degree flexion angle, the long-terni
effects on knee extension range of motion and skin tolerance should be detemined Also,
what are the long-term effects of weight bearing through the knee? Forces going through
these anatomical structures could be compared to the widely used patellar tendon-bearing
prosthesis and the Iess weil-known patellar tendon-bearing cast. HFC device
improvements may be based on already established weight bearing principles and
solutions to pmblcms previously encountered by weight bearing through this anatomical
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Vossberg, A. (1988).. The choice of prosthetic and orthotic technique for less developed countries: analysis and perspectives in Colombia Prosthet ûrthot Int, 12,96-100.
Ware, J.E. Ir., Sherboume, C.D. (1992). The MOS 36-Item Short-Fomi H d t h Survey (SF-36): conceptuai fhmework and item selection. Med Cam, 30,473483.
Waters, RL., Joyce, C., Thomas, L., Hugos, L., Davis, P. (1982). Energy costs of wallcing in lower-extrernity plaster casts* J Bone Joint Surg Am, 64(6), 896-899.
Werner, D. (1987). Disabled Village Children: A Guide for Community Heaith Workers, Rehabihtion Workers. and Families. Pa10 Alto, CA: The Hesperian Foundation.
White, Alastair. (1982). El Salvador. (Nations of the Modem WorId Senes.) Boulder, Colorado: Weskew Press
WHO. (2001). International Classification of Functioning, Disability, and Hedth, Geneva: W o d Health Organization.
A Field Studv of the iwalk-free Ambulatory Device in El Salvador
Subject Information Sheet and Consent Form
Investigator: KP FaIIon, MSc (candidate) School of Rehabilitation, Queen's University, Canada
Rehabilitation hstitute of El Salvador (ISRI) University of Don Bosco (UDB), El Salvador
Purposes of thb Study
This study aims to determine whether or not the new iwak-£kee (NF) ambulatory device can be effectively used as an alternative to the currently used axillary crutches (ACs) among subjects with a TTA and lower extremity injuries requiring a period of non- weight bearing.
If this study indicates that the IWF device is fiuictionally and culturally accepted within El Salvador, it may then be used as an alternative in other developing countries throughout the world
Procedures
If you agree to participate in this study, you will be required to participate in two I- hour sessions of testhg over the next four weeks. You will be randomly assigned to one of two groups. The only diffemce between the two groups will be the order in which you will trial and test the IWF device and ACs. Before you leave here today, you will be fitted and given instructions and practice in W g your assigned device by a trained p hysiotherapia You will then have two weeks to trial the ambulatory device. During this t h e you are encouraged to continue with your normal daily activities and work while noting any specifîc difnculties you may encounter. These diEculties win be reported during the subjective evduations duting your two folIow-up visits. Following the two-week period, you will return to this site where you wiil undergo both a subjective and hctional evaluation of this device. You wilI then be issued the second device (which you have not yet tried). In a simüar manner to the first trial, you will be given instructions and practice using the device. Mer two weeks of this device tria& you will return here for yoin second and fiai subjective and hct ional evaluation. At this tirne, you will also be asked to provide an overail prefemce rating betwetn the two devices.
Potential Risks and Benefits
There are no apparent rislcs to you A recent pilot study completed at two Canadian trauma centres cornparhg IWF to ACs indicated kgher d t s for the WF device in the
veasof everaLL hrnctiob c o m f i ~ a d easeofusc OR cads i n c d in getting to and from this site wil1 be reïmbursed to you In the event that you are injured as a result of these study procedures, you will be referred to your usual rehabilitative service for any necessary follow-up treatment
As for benefits, you rnay find that the use of the IWF device has given you more fkedom to p m e your normal daily activities. You may aiso gain satisfaction in acknowledging your contribution to the evaluation of a device that has the potential to positively affect the Iives of many individuals with amputations or lower limb injuries throughout El Salvador and the developing world*
Contact
If you have any questions or concems, please contact the principal researcher, Kelly Fallon at 503-274-6459 or her supervisor at Queen's University in Canada, Dr. Will Boyce at 613-533-6000 ex.77405, email: [email protected] or Heinz Trebbin, Coordinator for the career of Technicians in prosthetics, University of Don Bosco, San Salvador at 503-270-7922.
Subject's Statement
b @rint name) have read and understaud the above study information. 1 have been given suffkient time to consider the above information and to ask questions if I chose to do so. These questions have been answered to my satisfaction and should 1 have any further questions, 1 may contact the above names. 1 am voluntarily signing this fom. 1 am aware that my confidentiality will be maintained and my name will not appear on any of the publications or reports resulting h m this shidy. I undentand that 1 am fm to withdraw my consent to be in this study at any time and if 1 withdraw it will not affect my future prosthetic and rehabilitative seMce at ISRI. 1 will be provided with a copy of the study information sheet and this signed consent fonn.
PARTICIPANT NAME(p1ease prht) -9
PAKMCIPANT SIGNATURE WïI'NESS SIGNATURE
DATE DATE
The information within this consent form has been carefully explaineci to the participant To the best of my knowledge, helshe mderstands clearly the nature of the study and demands, risks, and bene* involveci in this study.
RESEARCHER SIGNATURE DATE
=-- -
Appendir B. Information Sheet and Consent Form (Spanish)
Una Continuacih en eI Cam00 de Estudio de los A~aratos Ambdatorios TAMINE LJBRE''
en El Salvador
Informacih / Forma de Consentimiento
Investigador: KP Fallon, BSc-PT, MSc (candidata) Escuela de Terapia de Rehabilitacih, Universidad Queen's, Canada
Institut0 de Rehabilitacih de El Salvador (ISRI) Universidad Don Bosco, El Salvador
Descripcibn del Estudio
Usted esta siendo invitado a formar parte en un proyecto de estudio dirigido por Kelly Fallon para evaluar la utilidad del aparato arnbulatorio del prototipo ''CAMINE LIBRE" entre individuos con amputaciones por debajo de la rodilla, O fracturas cornplejas del tobillo O esguinces en los que se han prescrite un reposo de peso de la pierna afectada. Los apariitos "CAMINE LIBRE" han sido disefiados en Canada para ser usados dentm Cana& y en los paises en vias de desarrolio. como El Salvador. La investigadora principal, Kelly Fd'alIon, un traductor en espallol, y KU técnico ortésico O fisioterapista l e e h esta hoja de idormacih 1 planilla de consentimiento a usted, descriiiendo detalladamente los procedirnientos y respondiendo cudquier pregwita que usted pueda tener. Este estudio ha sido respaldado por la Agencia de Desarrollo Internacional Canadiense (CIDA).
Procedimientos del Estudio
Si usted esta de anierdo en formar parte de este estudio, se le requed participar en d o s secciones de pmebas de una hora en las proXimas 5 semaaas dei aparata "CAMINE LIBRE" y de las muletas auxiliares. hunediatamente seguido de su amputaci60 O herida, se& asignado al szar a uno de los dos p p o s . La hica diferencia entre los dos gntpos sed el orden por el cual los dos aparatos se prueban. Se le dariin las instnrcciones de c6mo usar el aparato antes de marcharse.
Se le d d un periodo de una semana después de la lesibn O cuugia para el pmceso inicial de curacich y control del dolor. Luego, ten& dos semanas para ajustarse al aparato ambulatono. Duninte este periodo, se le anha a continuar con su normal ruha diaria. Despub de dos semanas, nosotros le localizaremos en su vecindad y usted completara el cuestionario y una prueba nmcional. Se le reqtterirh dar respuestas, verbaIes y escritas, al cuestiodo asi como también realizar la prueba fimciona.1 en la cuaI el investigador se le dadi ma nota final. Sus respuestas verbales serin grabadas en un cassette. Entonces le &riin el dispositivo que usted todavia no ha probado. Seguido a las dos semanas de prueba del segundo aparato, usted serA evaluado de la misma rnanera
--- ~~te tr sr tno-conetprsneraparat0=-&~grapo4 , u n r t v e z q u e s e e o a i p ~ ~ ~ k pruebas del aparato prototipo "CAMINE D R E " , se le p e M que devuelva el aparato al investigador.
Ai h a 1 de su participacih en este atudio, usted debed decidir si alquilar O comprar las muletas auxiliares. Sin embargo, dado a que el aparato "CAMINE LIBRE" todavia esta en etapa de desarrollo, se requiere de pruebas adicionales las cuales deben ser realizadas en El Salvador antes de que éstos puedan estar disponibles al uso publico.
Riesgos Po teneides y Beneficios
Existe el riesgo de malestar O dolor en el muo6n de la rodilla dado al aumnito de presih en el tendon y la tibia patelar. Tambien puede experimentar perdida de equilibrio y posibles caidas. Si esto ocune, informe al investigador principal O a su fisioterapista inmediatamente al siguiente numero de teléfono , Cl O ella evaluarhn el ajuste del aparato y realizaran los ajustes O cambios que sean necesarios.
Entre tanto usted pueda que no se beneficie directamente de este estudio, los resultados pueden mejorar el entendhiento de las adaptaciones y la conveniencia de ayudas ambulatonas dentro de El Salvador y en los paises desam>llados. Como resultado, las vidas fiituras de muchos amputados y lesionados pueden cambiar positivamente.
Confidenciaiidad
La inforrnacibn y &os obtenidos d m t e el curso de este esnidio se mmantendnh en completa confidencialidad. Su nombre no apareced en ninguna publicacih O reporte resultado de este estudio. Por el contrario, nosotros usaremos un cddigo y su nombre seni dishado. Los datos serin guardados en un a r c h o cenado, accesible solo por el investigador principal y el s u p e ~ s o r de la investigaci6n. Estos archivos y cassettes s e h guardados por un ak, luego del cual serin destniidos por el investigador. Existe la posibilidad de que las fotografias y / O videos de usted utilizando los aparatos puedan ser incluidos en la presentacib de este estudio en la Escuela de Terapia de Investigaci6n de la Universidad de Queen's, empleados y estudiantes para prop6sitos evaiuauvos y educacionales, a los socios de este proyecto &liados a la Universidad de Toronto, patrocbdos por ta Agen& Ente rnaCid € anadiense €BA, y nt cuidqukr d e u l o publicado d t a d o de este estudio. En esos casos, habd m a banda negra sobrepuesta en sus ojos de tai manera que su rostro no podrti ser identificado.
Retiro del Estudio
Su participaci6n en este estudio es voluntaria. Usted tiene el derecho de rehusar a f o m parte de este estudio y podd retirarse en cualquier momento, sin afectar sus fiituros tratamientos médicos en
. Ipuaimente, el investigador principal podri decidir retirario de este estudio su usted demuestra usar el aparato de
En el caso de que usted multe lesionado como d t a d o de los procedirnientos del estudio. usted sera refend0 al centro de tratarniento médico / rehabilitaci6n usual dentro de El Salvador.
Declaracibn de conformidad del participante y firma
Yo he leido y entendido la Infomaci6n / Consentimiento para este estudio. Me han explicado claramente los prop6sitos, procedirnientos y lenguaje técnico utilizado en este eshidio. Me han dado suficiente tiempo para considem la Uiformaci6n arriba indicada y buscar consejo si yo decido participar. He tenido la oportunidad de hacer preguntas las cuales me han respondido a mi entera satisfaccion. Estoy firmando de manera voluntaria este documento. Yo recibiré copia de este consentimiento para mi propia informacih. Si tengo en cualquier moment0 algunas preguntas, problemas O sucesos adversos. yo contactare al:
Investigador Principal: Kelly Fallon al 503-274-6459
S u p e ~ s o r de la Investigacih: Dr. William Boyce al 6 13-533-6000 ex. 77405, email: [email protected] O
Coordinador de la Carrera de Técnicos en Prostéticos, Universidad Don Bosco, San Salvador, Heinz Trebbin al 503-270-7922
Con la h a de este documento, estoy indicando mi conforniidad para participar en este estudio.
Fitma del Participante Fecha:
Fima del witnes Fecha
Nosotros, uno de mis colegas o mi persona, hemos explicado cuidadosamente al participante la naturalaa de la investigacih arriba indicada. Y puedo cemficar, con el mejor de mi conocimiento, que el participante entendit5 claramente la naturaleza del esnidio, las demandas, beneficios y nesgos que implican al participar en este estudio.
Firma del Investigador Principal Fecha:
Part 1
Please fil1 in the blanks or check O the appropriate box.
Pseudonym:
Date of Birth: Oly/mm/dd) Height:
Weight: Gender: C l Male Cl Female
Home: Cl Urban atea O Rural area
Occupation:
Location and
Have you used Cmtches Before? ilNo 0 Yes For how long?:
Associated Medical Conditions?: n NO O Yes, "specifY' (eg. cardiac, respiratory, neurological, balance or visual problems
which interfere with your mobility)
Any Medications cunentiy being taken?: UNo OYes " s p e w
Assigned Device: niwalk-~ree' millary crutches
Please respond to the following questions based on the previous 10 DAY use of your assigned ambulatory device. InteMewer is available to clarify any questions, if needed.
1. How many days in the pst 10 DAYS did you use your device? How many hours each da).
2. Please rate the level of difficulty while ushg your ambulatory device to each of the following activities: "Check box O for each activity"
No Moderately Very UnabIe Did not Problems Difficult Difficult (Attempted) Anempt
walk slow .............. 0 ....................... ....................... ff ....................... @ .................... C l WELUC fast ............... O ....................... a ....................... a ....................... a .................... UP stairs ................. a ................... ....a .................... ...O ....................... O ....................CI
................... down SM ............ O.... Ci ......... U U . . . . . . . ............. U up hi11 ................... .O ....................... Ci ..................... .. D ....................... @ .................... U down hi11 ................ O .......................Ci ...................... Cl ....................... O .................... D uneven terrain,. ...... O ....................... 0: ....................... ff .............. ff ... El odoff autobus.. ....- Cl ........-......*..... ...................... 13 ....................... O .................... O
....................... ....................... idout of car .......... -17 O O... .................... a....................El o d o E
....................... chair no amuests .... CI ............... ......... ....................... Ci O.. ............ .....O ............*......*. *.......*...**.***...... ...*....**.*.........*. ..............*..*. Toilet .................. ...*Ci .LI il O Cl
Comments on the most difficuit tasks you performed, explaining why they were difficult (please be very specific):
3; F e ebterisEies eonamGngy~tlt~-&viee are Listesi- belew. PI- indicate y- degree of satisfaction within the 1st 10 days for each one of these characteristics:
"Check box 0: for each characteristic"
Not at al1 Moderadatel y ver^ Completely Satisfied Satisfied Satisfied Satisfied
n r ) .............*....*........ ........................ ................ ......................*.. . a)Comfort ü u u .... ...El b)Appearance of the device ............. .Ci. ....................... ........ ................ O .................*..... ,.,.... .. U
........................... ......................*...... c)Weight .............. .. ... O O .a........ ....................... .O d)The way the device makes you
.........**........ .*.*.......*..*......a..*.*.. walk. ..a ............................ a O ................................. CI
Comments on the criteria with which you were moderately or not satisfied. (Please be very sspecific. eg. if 'cornfort' is one of these criteria, please hdicate how long each time you used the device before it becarne uncornfortable. Where was it uncordortable? During w hich activities?):
4. During the last 10 days, when you moved about IN THE HOUSE, approximately what percentage of your movements were done ...
"Check box O for each staternent"
a) ... waUMp with your ambufatory device ,.........,..,................. El ................... U .....,..........*.il ................. .............. O
b) ... waiking without your ambulatory
.................. ..*.......**..................... .,............... *............. device cl ...................Ki 0: O G
=- - 5 ~ ~ & m > t u s e ~ y o u r - a s s i & 8 w i e e ~ ~ o ~ t h e ~ f o r m o b i l i ~ W ~
HOUSE, could you state why? If you did use your device 100% of the t h e for getting around, Please proceed to question 8.
"Check Ki al1 of the appropriate box=" ........................ .....*..*.*...*.................... a) Because it was not fast enough.. .... .O . . ................................................................................... b) Because it was too tinng .O
............................................ c) Because my han& were not k e .................. ... d) Because of problerns with m y non-amputatedhon-injured leg.
................................... ............................. (eg. fatigue, pain, etc) .... il m a t problems?
e) Because of problems caused by the device itself ................................................. (eg. discornfort, pain, too cumbersome, etc). U
What problems f ) Because I felt unstable with the device ............................... ... ................ ....O
Under what circumstances? g) Because the device needed adjustrnent
(eg. too shodhigh, too loosdtight). ....... ... ............................................. .....Cl What problems?
h) Other reasons (speciw) U
6. During the last 10 DAYS, when you had to move OUTSIDE, approximately what pemntage of your movements were done ...
"Check box T! for each statement" ................................. ... aimost., .......... ....... ............-.. Amost
0% 25% 50% 75% 100% ... a) walking with your
ambulatory ............... device. ................ ... ................ U.. .............. .... .il .................. .ü..........r.....C[7 13
b) ... wdking without your arnbdatory
................. .................*.*......*..*..... .*.............*... ...*.........*..... ..*..*......... device Cl .0 Ci LI E
--- - 3. If y m d i d w t use- yetw d e v H e - ~ ~ o f - ~ t ù w f ~ r w b i i ~ OUTSEDE thehouse, couid you state why? If you did use your device 100% of the the, please proceed to question 10.
Check Cl al1 of the appropriate box= a) Because it was not fast enough .......................... .. ......................................... O
Approximately how many minutes to complete 1 OOm? . * P b) Because it was too tumg.......... ......................................................................... u After what distance?
....................................................................... c) Because my han& were not fiee O d) Because of problerns with my non-arnputatedhon-injured leg.
...................... (eg. fatigue, pain, etc). ....... ............................................... O What problems?
e)-Because of problems caused by the device itself .............................................. (eg. discodort, pain, too cumbeaome, etc). .O
What problems f ) Because 1 feIt unstable with the device.. ................................................... .......fi
Under what circumstances? g) Because the device needed adjustment
(eg. too shortkgh, too loose, tight) .............................. .... ..-........................Ci What problems?
h) Other reasons (specify) O
10. During the past 10 DAYS, have you had a fa11 while using your device? 17 No 17 Yes, "Number of falls"
What happened that caused you to fd?
Assigned Device: nbiwnlk-~ree' [7AxiIlary crutches
Please respond to the following questions bas& on the previous 10 DAY use of your assignai ambulatory device. Interviewer is available to c l d Q any questions, if aeeded.
1. How many days in the past 10 DAYS did you use your device? How many hours each day?
2. Name three activities which you customarily perform each day. Descnbe how the device has affected each one these activities. (eg. work-related activities, childcare, etc)
3. Name three leisure activities that you Iike to perform. Descnbe how the use of the device has affected each of these activities.
4. Pfease rate tke levet of Wfidty white ushg you, mbutetory deviee te eaeh of the foiIowing activities: "Check box Cl for each activity"
No ModerateIy Very Unable Did not Pro blems Difficult Difficult ( Attempted) Attempt
........... .......... Walk slow ....... ...il ........................ 17 ....,.........CI.. A....... ...Ci .................... ..................... ................. ......................... ....... walk kt...... cl *..,,.,a a.... CI a
.......... ......*...... .................. up stairs ............. .CI ..... ... u....~~.... a ........... .....,.......n ,. .a .................. d o m stairs ..... .,Li ........................ a..., ..................... Ci.... ....,.............. -Cl ...a .................. up hill. ........,...... LI.......... . . . . ,fi ............ -...,..... a...... .............. cl ...a ..................... .................... dom hill ............ f3 ........................ 0 ....................... -Ci..... U 0
uneven terrain ..... Ci ............. ..........Ci ...... ..............-...-Ci ........................ .O....... .......... il ..................... ......................... .*.,.*...........*.* .............**..*-.....- .... odof f autobus U ...Cl a a a ........... ..... ....... Meut of car. O....., ................. ~........~....~..~~.CC~.CCCU....~...........~.~~ ....~....11
d&: chair no annrests.Ei ........................ El .......................... m... .................... ..U .................... .U
....................... .*.*...*.....*.*...*. ............. ....................... .............. ToiIet .... û Ci ........ .,., 0 ..U U Comments on the most difficuit tasks you perfonned, explainhg why they were difficult (please be very specific):
S. Four characteristics conceming your device are Iisted below. Please indicate your degree of satisfaction within the last 10 days for each one of these characteristics:
"Check box O for each characteristic"
Not at al1 Moderadately Ve9' Completely Satisfied Satisfied Satisfied Satisfied
............................. ............................... ................... ........................... a)Codort ..O iJ U U b)Appearance
...........*....*............ ............................... .*................ ........................... of the device Ci 0: El il c) Weight .......... ..... ..... O ...........................O ............................. Ci ..............................O d)The way the device makes you wak... ....................... .................. tt.t......a ............................ ...................... ........O
Commenîs on the criteria with which you were moderately or not satisfied. (Please be very specific. eg. if 'cornfort' is one of these criteria, please indicate how long each tirne you used the device before it became uncornfortable. Where was it uncornfortable? During which activities?):
6. During the last 10 days, when you moved about IN THE HOUSE, approximately what ... percentage of your movements were done
"Check box Ufor each statement" ....................................................................... ahost.*. aImost
0% 25% 50% 75% 100% a) ... wdkhg with your ambulatory
b) ... waIking without your ambulatory device-. ............................ ...CI ..................... a... ............ .,..Cl ................. CI ............... 0.
X IE voo- di& RI>e use VOUF essi&&viss LW% of the éme f o ~ m e b i l i ~ EN TIFIE HOUSE, could you state why? If you did use your device 100% of the time for gening around, Please proceed to question 8.
"Check O al1 of the appropriate box&' a) Because it was not fast enough. .............,,,..,..,..,.,,.....+..........+ .............. [I
Approximately how many minutes to complete 100m? * *
b) Because it was too m g ......................... ... .................................................. U After what distance?
....................................................................... c) Because rny han& were not fiee O d) Because of problems with my non-amputated/non-injured leg.
................................................... (eg. fatigue, pain, etc). ........................... .. .O M a t problems?
e) Because of problems caused by the device itself .................................................... (eg. discornfort, pain, too cumbersome, etc). il
What problems ............. f ) Because 1 felt unstable with the device. ....... ................................... O
Under what circumstances? g) Because the device needed adjustment
(eg. too shortlhigh, too loose, tight). ............................................. .. ............. Ci What problems?
h) Other reasons (specify) O
8. During the last 10 DAYS, when you had to move OUTSTDE, approximately what percentage of your movements were done ...
"Check box U for each statement" ...................................................................... alrnost. almost
0% 25% 50% 75% 100% a) ... wallcing with your
.................... ................... .............. ambulatory device ............... 0 0 .O 0 ........... 0 b) ... walking without your
....................... ................W..*. ............... .............. ambulatory device .............. O 0 0 D 0
9. If you did not use your device 100% of the rime for mobility OUTSIDE the house, could you state why? If you did use your device 100% of the tirne, please proceed to question 10.
"Check C i ail of the appropriate box=" ......................................................................... a) Because it was not fast enough.. Ci
Approximately how many minutes m complete LOOm? . . ..................................................... ........................... b) Because it was too tmg .. il After what distance?
c) Because my han& were not fke. ................. .. ............... .... ................................ C d) Because of problems with my non-amputatedhon-in. leg.
(eg. fatigue, pain, etc). .................................................................................. ..O
vfhatprobk? e) Because of problems caused by the device itseif
(eg. discodort, pain, too cumbersome, etc). ................................................... 0 M a t problems
f) Because 1 felt unstable with the device. ............................................................ [J
Under what circurnstances? g) Because the device needed adjustment
(eg. too short/high, too Ioose, tight). ................................................................ ü What problems?
10. During the past 10 DAYS, have you had a fa11 while using your device? O No O Yes, "Number of falls"
What happened that caused you to fall?
11. Overall, what are your impressions of your assigned ambulatory device?
12. If you have completed the trial periods for both devices, which device do you prefer overd:
O axillary crutches
Aparato de Asistencia para las Extremidades Inferiores Aceptacih (ENFOQUE-A)
Parte 1
Por favor rellenar los espacios en blanco O marcar el recuadro.
Fecha: (afioImes/dia)
Nombre:
Fecha de nacimiento: (aiio/mes/dia) AI tura:
Peso: Sexo: UMascuIino 0 Fernenino
Hogar: 0 Urbano O R d
Fecha de amputacibn 6 Iesi6n: (&ïo/rnes/dia)
Lugar y tipo de amputacion 6 lesi0n:
L H ~ usado muletas anteriormente? I7No El Si LCuhto tiempo?:
Otras condiciones medicas relacionadas: (Otros Problemas de Salud que tenga): Cl No O Si, "especificar" (Ej.: proHemas cardiacos, respiratonos, visuales que interfieran
con ni movilidad, neun>I6gicos, equüibrio)
jMedicamento tomados?: ON0 O Si "especincai'
Aparato asignado: O 'Carnine libre' Ci mdetas auxiliares
Por favor, responda a las siguientes preguntas basadas en las 10 dias previas al uso de su aparato ambulatorio asignado. El entrevistador esta disponible para clarificar cualquier pregunta, si a necesario
1. jC~antos dias en las riltimas IO dias ha usado el aparato? Cuantos horas cada dia?
2. Por favor, evaltie el nive1 de dificultad tuvo mientras usaba el aparato ambulatono de las siguientes actividades: "Marcar el recuadro O por cada actividad"
No Dificultad MUY incapaz No Problemas Moderada Dificil (Intentado)
Intentado ...................... .................... ............... Caminar despacio ............ 0 0 ................... .... O ... 0 U
....................... Caminar ritpido.. .............. O. ..................... O ....................... O 0 ............... 0 ...*... **...*.**...*.*........ ............... Subir escaleras. ................ a .... ........... @ ....................... O U
bajar escaleras ............... ..O ...................... O ....................... O ....................... CI ............... ff S U ~ U C O I ~ S ..................... a ................... ,.,a ....................... n ....................... E ............... 3
n ....................... ....................... ............... ...................... ..................... bajar colinas - C1 U n terreno desnivelado ......... U ..................... Ci ................. ...... [7........... ............ U ............... O
................... ....................... ............... ..... ...................... subù/bajar del autobiis CI 0 .... O 0 El subirhajar de1 carro ......... Cl ....................... C l ...................... O ....................... 1 ............... ti sentarsdpararsede una
**.... ..*......*.....*..*.... silla sin brazos: ................. il ................ D ....................Cln Cl ...............O B a 0 ................................. O ...O................. 0 .......................D...,...... ............ Ci ............ ....il Comentar las tareas rnb dificiles que usted ha realizado, explique por qué ellas fiiemn dificiles (Por favor sea muy especinco):
3 Escribtteuatm eerctsteFisiieasque leinte-& sttapa~aao aMgnadeen ksiguieote lista Por favor, indique su grado de satisfaccih por cada una de estas caracteristicas:
"Mascar el recuadro G de acuerdo a cada caracteristica*
Nada Moderadamente Considerablemente Completamente Satisfecho Satisfecho Satisfecho Satisfecho - c1 n a) Comodidad. .......... .... u ..................... ........................... u ................................ El
b) Apariencia ............................ de su aparato ............... U ..................... U a. ............................. O
c) Peso .**............ ............ n .........*...... *..**.u.. ........,,.. ,,.a ........**...........*........ d) El modo en que
usted carnina con el aparato ............. ... .... U .................... 0 .......................... U . . . ....
Cornentarios sobre su criterio con el cual usted estuvo moderadamente O no satisfecho. (Por favor sea muy especifico, por ejemplo si el comodidad es uno de estos cnterios favor indicar cuanto tiempo en cada actividad hizo uso del aparato antes de convertirse incomodo para usted)
4. Durante las IO ultimas dias, cuando usted tenia que movilizarse EN SU CASA, ... aproximadamente que porcentaje de ni movilizacih fite realizado
"Marcar el recuadro Rpor cada fiase"
a) ... caminando con sus ..... aparatos ................................ U ..... 0 .................. C l ...... U. ......... .....il
... b) caniinando sus 1 8parat05 ................ .. ................. *****...*..*Li ..... ..*.....*.D
5. Si usted no utiliza su aoarato el 100% del tiempo para movilizarse EN SU CASA, podria decimos por qyé? AqtîeiZos que utiiicen su aparuto el 100% del rienpo para moverse, fmor de pasar a la pregunta 8. "Maque fl todos los recuadros apropiados"
. a) Pot que no es suficientemente rapido ............. .... ...................................... O b) Por que esta muy cansado ............... .. .................................................................. ti
........................... c) Por que mis manos no se encuentran Libres ................. ....... O ci) Por los problemas con mi pierna no amputada I herida
........................................................... (Por ejemplo fatiga, dolor de muSculo,etc.) O ~ Q u é p r ~ b l e ~ ~ ~ a ~ ?
e) Por los problemas causados por mi apanito (Por ejemplo hcomodidad, dolor, sudoracih, etc) ............................................ i3 ~ Q u é problemas?
£) Por que me siento inestable con mi aparato ................... ... ............................... jEn cuales circunstancias?
g) Por que mi aparato necesita ajuste (Por ejemplo muy corto (alto), amplio(flojo), etc.) .............................................. G jQué prob Iemas?
-h) Otms razones (especifique) 0:
6. Dunuite los 10 ultimas dias, cuando usted tiene que desplazarse, RIERA, aproximadamente qué porcentaje de sus desplazamientos es reaiizado..
"Marque O por cada k e " .......... cas1 un ..................* .........*................................. ..cas1 un
0% 25% 50% 75% 100% a) ... caminando con su aparato ................................. U . . . . ............. .................. a................. !J..........fl
b) ... caminando & su .................. ................. aparato ................................. ................... O O 0 ..............LI
7. Si usted no utiliza su aparato el 100% del tiempo para sus desplazamientos FUERA, podn'a dechos por qué? .4quellos que utificen su aparato el lUOW del tiempo para moverse, ffmror de paar a la pregunta 1 O.
"Marcar O todos los recuadros apropiados"
a) Porque no es suficientemente dpido ............. ... .... ... ................................ O ~ C u h t o s minutos tarda en caminar 1 OOm?
b) Poque estoy muy cansado ................................................................................. 3 ~ D e ~ p u é ~ de qué distancia?
c) Porque mis manos no se encuentran libres ...................... .. ............................ O d) Por los problemas con mi piema no amputada I herida
Cporejtmplo Mg2, dotor de maScdo, etc). .........+..+... ...... ........................ El jQué pmblemas?
e) Por Ios problernas causados por mi aparato .............. (Por ejemplo incornodidaci, doior, sudoracion, etc.) ....... ............. Cl
j Q ~ é problemas? f ) Por que me siento inestable con mi aparato ......................... .......................-...-...11
@n qué circunstancias? g) ûtras razones (especifique) [S
8. jDurante los 10 ultimas dias, se ha caido con su aparato? U No
Si, "Numem de caidas" que sucedio para que se cayera?
(ENFOQUE-A) Cuestionario Parte 3
Aparato asignado: O 'Carnine libre' muletas audiares
Por favor, responda a las siguientes preguntas basadas en las 10 dias previas al uso de su aparato ambulatorio asignado. El entrevistador esta disponible para clarificar cualquier pregunta, si es necesario
1. jCuantos dias en las a m a s 10 dias ha usado el aparato? Cuantos horas cada dia?
2. Mencione tres actividades que usted realiza todos los dias. Describa como el aparato ha aféctado el desernpefio de cada una de estas actividades (Por ejemplo actividades relacionadas con el trabajo, cuidado de ninos, etc)
3. Nombre tres actividades que durante su tiempo libre guste realizar. Descnba como el uso del aparato ha afectado cada ma d e estas actividades.
4. Por favor, evalie el nive1 de dificuitad tuvo mientras usaba el aparato ambulatorio de las siguientes actividades: "Marcar el recuadro O por cada actividad"
No Difidtad Muy Iacapaz No Problemas Moderada Dificil (Intentado) Intentado
II .... .................. ................... ...................... Carninar despacio.. Cl u 0 ................. 0 r - ............ ....................... Caminar rapido ti ..................El ....... ..... Ci ...................LI
Subirescaleras.. ............ CI .................. 17 ................... O................ ....... U....................17 bajar escalaas ............ .. U .................. U ............... I7 ....................... O .................... 0 subir col inas.... ............. U.........., .... ,..[7... ................ O.....,.......... ....... ti .................. ..O
.................... ................... ................ .................. ................ bapc<& 0 G ..a..; 13 Q .........**.....*.* .....*................. .......,.......,.. *................... terreno desnivelado ...... 0 0 El C! U
....................... subirhajar del autobh il .................. U ................... O 0 .................... Q .. ................ subirhajar del cm... 0 U ................. U ....................... il .................... D
sentarselpmede ma silla sin brazos: ............ ~............... ...CI ............ .......O: ....................... U ................ ....Cl
.................... BaiIo ............................ O .................. O O....... ................ Ei .................. ..Cl Cornentar las tareas mis dificila que usted ha reaiizado, explique por qué ellas fueron difides (Por favor sea muy especinco):
5. Escriba cuatro caracteristicas que le interesan de ni aparato asignado en la siguiente lista. Por favor, indique su p d o de satisfaccih por cada una de estas caracten'sticas:
"Marcar el recuadro O de acuerdo a cada caracteristica" Nada Moderadamente Considerab lemente
Cornpietamente Satisfecho Satisfecho Satisfecho Satisfecho
n n n ................................. ............. ....... ....................... ............. a)Comodidaa - - ... - ' b)Apariencia - -
................... ........................... .............................. de su apanito ............. .Q .... O O .O @Peso .................... *..a ....................... cl ................... .........O ............................ ....O d)El modo en que usted camina con e1
................................. aparato ....................... ff ............ 1 Cl
Cornentarios sobre su criterio con el cual usted estuvo moderadamente O no satisfecho. (Por favor sea muy especinco, por ejemplo si el comodidad es uno de estos aiterios favor indicar mmto tiempo en cade zreti\ridd Ltim use de4 eparato antes de eowe*e incornodo para usted)
Q DuPan~las10~initrsdiapis~~~t~teniequet~,viEizaFseWSU~ASA, aproximadamente que porcentaje de su movilizacih fue reaiizado ...
"Marcar el lecuadro O por cada fuw" Cas1 Un.... ..................*...................................*............... C l un
0% 25% 50% 75% 100% ... a) caminando - con SUS
..................... .................... aparatos ...................................... 0 ................ O 0 Cl ............... 0
b) ... caminando - sin SUS ..................... .................... aparatos ................... ... ......... O ................ O O ...............Cl
7.- Si usted no utiliza su amrato el 100% del tiempo para movilizarse EN SU CASA, podna decirnos por que? Aquellus que utilicen su uparuto el 100% del tiempo paru moverse, favor de pusar a ia pregunta 8.
"Maque O todos los recuadros apropiados"
a) Por que no es suficientemente riipido ............................ .... ................................... 0 b) Por que esta muy cansado ............................................................................... D c) Por que mis manos no se encuentran libres ................... .... ........................... Q 6) Por 10s problemas con mi pierna no amputada / herida
(For ejemplo fatiga, dolor de mriscu10,etc.) .......................................................... Cl ~ Q u é problemas?
e) Por los problemas causados por mi aparato (Por ejemplo incornodidad, dolor, sudoracion, etc) ...................................... ... .. 0 ~ Q u é problemas?
f) Por que me siento inestable con mi aparato ................. .... ........................ O iEn cusles circunstancias?
g) Por que mi aparato necesita ajuste (Por ejemplo muy corto (alto), amplio(flojo), etc.) ............... .... ...................... 0 ~ Q u é problemas?
h) Otras tazones (especifique) CI
8. h a n t e los 10 ultimas dias, cuando usted tiene que desplazarse, FUERA, aprmimadamenteqtté porcentaje demi despWentos es d i z a d o . .
"Marque O por cada h e " cas1 un ..................................... 1 un 0% 25% 50% 75% 100%
... a) caminando con su .................... aparato .................................... û ................ [l.................. C! ................. El ..Ci
... b) canilnando su .............. aparato .................................. O... ........ .......... .. ...... CI ................. U ........ Ci
9L SCmteemuti~su~0~I~deCtiémpbpara~~~despiazamien~05 FERA, podria decirnos por que? Aquellos que utilicm su aparato el 100% del tiempo para moverse, favor de pasar a la pregunta 10.
"Marcar O todos los recuadros apropiados"
a) Porque no es suficientemente riipido ............. .. .................a...................-.......... tl ~ C U ~ O S minutos tarda en caminar 1 O k ?
0 b) Porque estoy muy cansado ............... ... ...................................................... u jDespués de qué distancia?
....................................................... c) Porque mis manos no se encuentran libres U d) For los problemas con mi piema no amputada / herida.
(Por ejemplo fatiga, dolor de miisculo, etc) ........................... ... ..................... t! ~Qué problemas?
e) Por los problemas causados por mi aparato (Por ejemplo incornodiciad, dolor, sudoracibn, etc.) ........................................ C3 j Q ~ é problemas?
............................... £) Por que me siento inestable con mi aparato O jEn qué circunstancias?
g) Otras razones (especifique) U
10. j D m t ê los 10 ultimas dias, se ha caido con su aparato? U No U Si, Wumero de caidas"
&Que sucedi0 para que se cayera?
11. jEn generd, cuales son sus impresiones de su aparato ambulatono asignado?
12. Si usted ha tratado ambos aparatos, mal de los dos prefiere:
CI 'Carnine libre' Cl muletas awciliares
Rendimiento del Aprrato de Asistencia para Las Extremidades [nferiores (ENFOQUE-P) Medida
Antes de intentar completar cada una de las siguientes actividades, los participantes deben recibir instrucciones verbales asi corno también una dernostracion fisica. A los participantes se les permitira una practica de prueba y una evaluaci6n de piueba Los evaluadores deben anotar el tipo de aparatos de asistencia utilizados.
4-Si, realizado sin dificultades
3 4 , realizado con un poco de dificultad (auto-correccion de perdida de equilibrio)
2-Si, realizado con mucha dificultad. (Requiere apoyo externo/apoyo para recuperar el equilibrio)
1-No, incapaz de completar la tarea.
Apatato hbado: O Camina Libre Cl Muletas Auxilares
I. Moviiizarse de estar de pie a una position sentada, y de ma posicih sentada a ponerse de pie de una siIla sin brazos .......................................................
............................................................. 2. Subir y bajar la acera. ................ .........
3. Cargar un vaso de agua por 5 rnetros ........................ ... ............................... 4. Subir y bajar las escaleras sin usar el pasamanos .......... ... ...............................
5. Subir y bajar una superficie inclinada de 10 metros con una superficie ............................................................................................................. desnivelada
...................................... 6. Caminar 10 mems por un temeno mojado y enlodado
................................. 7. Abrir la puerta, caminar a través de eiIa y luego cerrarIa..
8. Aicance una mano encima de la cabeza mientras mantiene un buen ...................................................... equilibrio (corno si esnMera en un autobiis)
9. De una posicih erguida inclinme y recoger una monda encontrada sobre el ...................................................................................................................... sue10
Nota Total:
Ankle # Ankle # T'TA Ankie # TTA Ankle # TTA TTA Foot # TTA Foot # TTA TTA Ankie # Ankle # Ankle # Foot # m4 Foot # TTA TTA M e #
Subject TTA or Gaidd Age Height Weight Home 1' Days Overall Fracturea (years) (cm) (kg) location Device using Device
test& AC? preference Urban HFC O AC U h m Uhan Utban Urban Urban Rural Rural Rural Urban R d Urban Urban Urban Rural Rural Urban Urban Urban Rural Urban Urban
AC HFC HFC HFC W C AC AC HFC AC KFC HFC AC AC AC AC W C AC AC AC HFC AC
W C AC KFC AC AC AC AC AC HFC AC HFC AC HFC HFC HFC AC AC HFC AC AC AC
- - - - 168 66 Rural AC 10 AC 'TTA = trans-tibia1 amputation; # = hcture M = male; F= female in some cases, subjects had aiready been using AC pnor to theu initiation into the study.
