Neurology International 2009; volume 1:e10

[page 36] [Neurology International 2009; 1:e10]

Effectiveness of home rehabilitation for ischemicstrokePakaratee Chaiyawat, KongkiatKulkantrakorn, Paskorn SritipsukhoFaculty of Medicine, ThammasatUniversity, Pathumtanee, Thailand

Abstract

The objective of this study was to developand examine the effectiveness of an individualhome rehabilitation program for patients withischemic stroke. This was a randomized con-trolled trial in 60 patients with recent middlecerebral artery infarction. After hospital dis-charge for acute stroke care, they were ran-domly assigned to receive either a home reha-bilitation program for three months (interven-tion group) or usual care (control group). Wecollected outcome data over three months aftertheir discharge from the hospital. The BarthelIndex (BI), the Modified Rankin Scale (MRS),the health-related quality-of-life index (EQ-5D), the Hospital Anxiety and Depression score(HADs), and the Thai Mental State Exam -ination (TMSE) were used to analyze the out-comes. In the intervention group, all outcomeswere significantly better (p<0.05) than in thecontrol group, except in the case of TMSE. Afavorable outcome, which was defined as mini-mal or no disability as measured by BI (score95-100), was achieved by 93.33% of patients inthe intervention group, and 90% had favorablescores (0 or 1) on the MRS. This showed a ben-efit in reducing disability, with two being thenumber of patients considered as needed-to-treat (NNT) (95% CI, 1.0-1.2). All dimensionsof EQ-5D in the intervention group were signif-icantly better for quality of life and generichealth status than in the control group(p=0.001). Depression was found in onepatient (3.33%) in the intervention group andin two patients (6.67%) in the control group.Dementia was found in three patients (10%) inthe intervention group and in four patients(13.33%) in the control group. We concludedthat an early home rehabilitation program forpatients with ischemic stroke in the first three-month period provides significantly better out-comes in improving function, reducing disabil-ity, increasing quality of life, and reducingdepression than a program of usual care does.

Introduction

Stroke is the leading cause of disability in

adults around the world, including Thailand.1

Ischemic stroke caused by large artery athero-sclerosis and cardioembolism is found in 20%and 15% of stroke patients, respectively.2

Individuals who have a stroke also endure agreat deal of suffering; for example, physicallimitations, emotional trauma, job loss andfamilial rejection because of the burden.3 Mostmotor and functional recovery usually occursin the first three months after a stroke.4

Moreover, depression and dementia signifi-cantly affect the quality of life and physicalability of stroke patients.5-8 The duration ofhospital stays for rehabilitation of acute strokepatients has decreased, so recovery often is notcomplete at the time of discharge.9 The conse-quences after discharge may involve not onlypersistent neurological impairment, but alsolifetime disability. An attempt to solve thisproblem may require a novel rehabilitationprogram to maximize patients’ function inovercoming their disabilities.

Many studies have been conducted to exam-ine rehabilitation of stroke patients, but theresults have been inconsistent. Previous stud-ies have documented that patients usuallyhave significant residual physical disability,functional impairment, and reduced quality oflife.10 Some studies have shown that motorfunction gradually returns only as a result ofspontaneous recovery. Therefore, stroke reha-bilitation programs may not improve out-comes.11,12

Several studies10,11,13-15 have suggested thathome rehabilitation is more effective andcheaper than usual care. Rehabilitation begunearly in the acute stage optimizes the patient’spotential for functional recovery. Early mobi-lization prevents or minimizes the harmfuleffects of deconditioning and the potential forsecondary impairments. Recovery from strokeand relearning is based on the brain’s capacityfor reorganization and adaptation. An effectiverehabilitation plan capitalizes on this potentialand encourages functional use of the involvedparts of the body. Activities are selected thatare meaningful and important to the patient.Optimal motor learning can be ensuredthrough attention to a number of factors: mostimportantly, strategy development, feedback,and practice. Rehabilitation can begin as soonas the patient is stabilized medically, typicallywithin 72 hours of insult. Patients may beadmitted to a specific stroke unit or neurologi-cal unit with rehabilitation services. Evidencesupports the benefits of such services in sig-nificantly improving functional outcomeswhen compared to patients not receiving thoseservices.

In most developed countries there is a heavyreliance on hospitals for acute care, whereashome rehabilitation of stroke patients is limit-ed.13,14 Because inpatient rehabilitation pro-grams in Thailand are not widely available, the

demand for home rehabilitation is increasing.Therefore, a model for effective home rehabil-itation for stroke patients will help improvestroke care, and could be applied to other coun-tries. To date, no randomized controlled trialhas assessed the effectiveness of a home reha-bilitation program for victims of ischemicstroke from middle cerebral artery infarction.

Therefore, our study evaluates the effective-ness of a home rehabilitation program forpatients with ischemic stroke. We postulatedthat the program would be able to improve theactivities of daily living (ADL) of strokepatients who had suffered middle cerebralartery infarction, as well as decrease disability,increase quality of life, reduce depression, andalleviate dementia.

Materials and methods

DesignThis was a randomized controlled trial

(RCT). All eligible subjects gave their informedconsent, and the study was approved by theThammasat University Institutional ReviewBoard.

Patient population – inclusion andexclusion criteria

Patients with stroke as a result of middlecerebral artery infarction were recruited frominpatient wards at Thammasat UniversityHospital from May 2007 to June 2008. Theywere screened for eligibility around three daysafter onset of the stroke. Screening was either

Correspondence: Kongkiat Kulkantrakorn, Neurology Division, Department of InternalMedicine, Faculty of Medicine, ThammasatUniversity, Pathumtanee 12120, ThailandE-mail: kongkiat1@gmail.com

Key words: effectiveness, home rehabilitation,ischemic stroke

Acknowledgements: this study was supported byfunds from Thammasat University. The authorsgreatly appreciate the cooperation of the physi-cians and staff at Thammasat University, as wellas the caregivers of the patients.

Received for publication: 6 April 2009.Revision received: 29 July 2009.Accepted for publication: 24 August 2009.

This work is licensed under a Creative CommonsAttribution 3.0 License (by-nc 3.0).

©Copyright P. Chaiyawat et al., 2009Licensee PAGEPress, ItalyNeurology International 2009; 1:e10doi:10.4081/ni.2009.e10

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[Neurology International 2009; 1:e10] [page 37]

based on a clinical diagnosis, or was performedexclusively with or aided by magnetic reso-nance image (MRI) or computer tomography(CT) scanning. The main inclusion criteria ofthe trial were: stroke from middle cerebralartery infarction, patient’s and caregiver’s will-ingness to participate, ability to provideinformed consent, and living within 50 milesof the hospital. Patients were excluded if theyhad uncontrolled hypertension, had severedysphasia or cognitive impairment, hadalready been discharged to residential care,had demonstrated previous disability in self-care, or had been living in a nursing homeprior to the stroke.

RandomizationEligible patients were stratified by gender

and age (≤40 years, >40 years). Hence, theparticipants were divided into the followingfour categories: males aged less than or equalto 40 years, females less than or equal to 40years, males more than 40 years, and femalesmore than 40 years. In each stratum, eachindividual was numbered consecutively. Thesenumbers had previously been randomizedequally between the intervention group andthe control group. After giving informed con-sent, patients were randomly allocated toreceive either a home rehabilitation program(intervention group) or usual care (controlgroup). This method was used to regulate thenumber of patients who were allocated to theintervention group, which otherwise wouldhave resulted in a significant bias in the study.In addition, block randomization allowed fairallocation of independent persons against thepotential bias because of changing practicesover the three-month duration of the study,which could have resulted from unevenrecruitment between intervention and controlgroups at the beginning and the end of thestudy. Randomization was performed by asequence of sealed envelopes in which thetreatment assignment was given, using a ran-dom number table and block randomization ina fixed box of each strata.

Intervention groupIntervention consisted of an individual’s

home-based exercise program provided by aphysical therapist once a month for threemonths. The physical therapist evaluated arange of functions related to indoor and out-door mobility, as well as some basic ADL,before providing a home rehabilitation pro-gram for the stroke patient. Individual counsel-ing, which focused on education, applyinginformation learned in practical situations,and solving problems occurring at home, wasoffered to the caregiver if needed. The inter-vention strategy was based on principles ofexercise physiology and motor learning, and

had been developed with the combined input ofexperts, stroke patients, physical therapists,occupational therapists, and speech therapists.It consisted of standardized rehabilitation pro-cedures on an audiovisual CD: passive exer-cise, active exercise, resistance exercise, andADL, including putting on and taking off shoes,how to use a cane or wheelchair, etc. The dura-tion and type of therapy were recorded on acase report form by the therapist. Each homeprogram lasted approximately one hour.Patients or caregivers were asked to keepdiaries between therapy sessions on the timeand type of training. Caregivers were instruct-ed on how to assist patients in ways thatallowed patients to use their functional skillsas much as possible.

Control groupPatients in the control group and their fam-

ily members were given instructions for homerehabilitation prior to discharge from the hos-pital. The usual care after discharge mayinclude outpatient rehabilitation at the discre-tion of the patients’ physicians. Other treat-ments were to be recorded in the case reportform. The control group did not have follow-uphome visits.

Usual care1. Patients received services as prescribed by

their physicians.2. All patients had physical therapy when they

were admitted to the hospital.3. Patients and family members were given

instruction for home rehabilitation prior todischarge from the hospital.

4. Patients may receive outpatient rehabilita-tion at the discretion of their physicians.

OutcomesThe Barthel index (BI) is a weighted scale

of 10 items of basic ADL. The possible range ofBI scores is 0 to 100; a score equal to or morethan 95 is considered as indicative of the abil-ity of independent self-care.15

The Modified Rankin Scale (MRS) providesan assessment of the degree of disability.Minor strokes are considered as grades 0 to 2;major strokes are grades 3 to 5; while fatalitiesare grade 6.15

Categorizing patients into different out-come groups by the BI or MRS has been usedin major clinical trials.15,16 This method is animportant measure of showing the meaningfulbenefits of stroke intervention in clinical prac-tice. The health-related quality-of-life index(EQ-5D with five distinct dimensions) con-cerns mobility, self-care, usual activities,pain/discomfort, and anxiety/depression. TheEQ-5D can be informative in describing thedynamics of health-related quality of life dur-ing treatment and follow-up.17 Depression out-

come was assessed by Hospital Anxiety andDepression scores (HADs). Depression wasdefined as scores equal to or more than 11(range of scores: 0 to 21).8 Dementia outcomewas assessed by the Thai Mental StateExamination (TMSE). Dementia was definedas scores lower than 23 out of 30.8 EQ-5D andHADs have been translated into Thai and vali-dated according to international standards.

Follow-upFollow-up visits at patients’ residences were

scheduled at one, two, and three months afterdischarge from the hospital. All patients andcaregivers were interviewed and evaluated attheir residences. Systematic assessments fol-lowed a case report from only one assessor.However, a blind study including patient andassessor was not practical for this study. Theassessor had adequate training and wasaccredited in using the National Institute ofHealth Stroke Scale (NIHSS) and the MRSscale.

Sample sizeThis study, with 30 patients per group, had

an 80% probability of achieving a statisticallysignificant result at a two-sided 5% level if themean differences between the BI scores for thegroups and the standard deviation were 4.8and 6.7, respectively.10

Statistical analysisData were analyzed by STATA for Windows

version 10 software. Descriptive statisticswere used to characterize demographics, per-formance, and clinical characteristics for eachgroup. All analyses were performed on anintention-to-treat (ITT) basis. The continuousoutcomes of the BI and utility index were ana-lyzed by analysis of covariance (ANCOVA),with the baseline as a covariate and age anddepression as factors in the model. The level ofsignificance was set to 0.05. Outcomes wereclassified into one of four categories: minimalor no disability (BI score of 95-100, or MRSscore of 0 or 1); moderate disability (BI: 55-94,or MRS: 2 or 3); severe disability (BI: 0-54, orMRS: 4 or 5); and death. A favorable outcomewas defined as minimal or no disability, asmeasured by scores of 95 to 100 on the BI, and0 or 1 on the MRS, HADs less than 11, or TMSEequal to or more than 23.17

Results

Sixty-eight subjects were approached andscreened for their eligibility to enroll in thisstudy; 60 patients met the inclusion/exclusioncriteria (Figure 1). All gave their informed con-

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sent for participation. Eight patients wereexcluded because of severe aphasia, severecognitive impairment, living outside the area,or being discharged to residential care. Twopatients in the usual care group died becauseof a cardiovascular problem before the secondevaluation at home. There was no significantdifference in baseline characteristics andinpatient hospital days between the two groups(Table 1). However, there was a major differ-ence in the proportion of patients with righthemisphere stroke (20%).

In the intervention group, all outcomes weresignificantly better (p<0.05), except in thecase of TMSE, than in the control group (Table2). At three months, the BI showed more sig-nificant improvement in the interventiongroup than in the usual care group: 96.33±1.04 vs. 66.25±1.58, p=0.001 (Figure 2). Afavorable outcome, which was defined as min-imal or no disability as measured by scores of95-100 on the BI, was achieved by 93.33% ofpatients in the intervention group; 90% hadfavorable scores of 0 or 1 on the MRS (Figure3). There was a benefit in reducing disability,with a needed-to-treat (NNT) number of two(95% CI, 1.0 to 1.2). The utility index compari-son was 0.88±0.02 vs. 0.53±0.02, p=0.06. Inaddition, when we compared the mean out-comes for the five dimensions (mobility, self-care, usual activities, pain/discomfort, anxi-ety/depression) of the EQ-5D at three months,all dimensions of the EQ-5D in the interven-tion group were significantly better for qualityof life and generic health status than in thecontrol group (p=0.001). HADs were also sig-nificantly different between the interventionand control groups. There was an improvementin HADs for both groups, but the interventiongroup improved more. Depression was foundin 20 patients (66.67%) at baseline and one(3.33%) patient at three months in the inter-vention group; while it was found in 25(83.33%) patients and two (6.67%) patients,respectively, in the control group. TMSE scoreswere not significantly different between theintervention group and the control group. Atthree months, dementia was found in threepatients (10%) in the intervention group andin four patients (13.33%) in the control group.There were no serious adverse events in eithergroup. Compliance with the intervention,based on daily records, was 95%.

Discussion

The present study has provided additionaldata supporting the remarkable benefits of ahome rehabilitation program. After threemonths, home rehabilitation intervention pro-duced greater gains and higher rates of func-tional independence, ability, and quality of life

than did usual care. Intervention appears tohave accelerated recovery within three monthscompared to usual care. The factors responsi-ble for this superiority of organized strokerehabilitation may include support from thefamily system, the initiation of earlier rehabil-itation, the home environment of rehabilita-tion, an individually tailored program withaudiovisual materials, and close follow-up.10,12,14,18 An assessor evaluated each patienton four separate occasions, and a physicaltherapist provided three home rehabilitationvisits all of which contributed to reducing non-response. The patients received the physicaltherapist’s telephone number for consultation

about the home rehabilitation program.Compliance with the intervention (as indicat-ed by daily records) at one, two, and threemonths was 94%, 95%, and 95%, respectively.The response rate achieved was 100%. Thesuccess of rehabilitation also depends on per-sonal factors of stroke patients, such as age,education, socioeconomic status, medical his-tory, and family relationships.10,19 Moreover,audiovisual materials (video CDs) may aid inrecovery, which could be explained by the mir-ror neuron theory. Buccino et al. (2006)20 pro-posed the mirror neuron theory in the recoveryof motor function and the reorganization ofneural network integration, involving both the

Table 1. Subject characteristics and baseline measures.

Intervention Group Control Group(n=30) (n=30)

Age (yrs), mean (SD) 67 (10) 66 (11)Male, n (%) 14 (47) 13 (43)BMI, mean (SD) 24.8 (1.6) 24.6 (2.4)Elementary education, n (%) 28 (93) 28 (93)Length of stay in hospital before 10 (1.7) 10.9 (2.3)discharge, mean (SD)Right hemisphere stroke, n (%) 18 (60) 12 (40)Medical historyHypertension 17 (57) 17 (57)Diabetes 16 (53) 18 (60)High cholesterol 8 (27) 6 (20)Atrial fibrillation/Ischemic heart disease 7 (23) 8 (27)

National Institute of Health Stroke 16.4 (4.1) 17.8 (3.9)Scale (NIHSS), mean (SD) Thai Mental State Examination (TMSE), mean (SD) 24.4 (2.0) 23.8 (1.9)Hospital Anxiety and Depression Scale (HADs), mean (SD) 16.1 (7.6) 16.4 (4.9)Barthel Index, mean (SD) 31.7 (5.9) 33.2 (4.8)Modified Rankin scale, n (%):Minor strokes (Grades 0-2) 0 0Major strokes (Grades 3-5) 30 (100) 30 (100)

Utility index, mean (SD) - 0.14 (0.08) -0.11 (0.13)

* p by independent sample t-test and Fisher's exact test, significant at p<0.05.

Table 2. Results of ANCOVA adjusted for age, depression, dementia, and baseline meas-urement of outcome at three months.

Intervention group Control group Mean difference(n=30) (n=28) 95% CI

Barthel index, mean (SE) 96.3 (1.0) 66.3 (1.6) 56.32(25.59,87.04)

Modified Rankin scale, n (%)Minor strokes (Grades 0-2) 28 (93.33) 3 (10)Major strokes (Grades 3-5) 2 (6.66) 25 (83.33)

Utility index, mean (SE) 0.88 (0.02) 0.53 (0.02) 0.57(0.17,0.97)

Thai Mental State Examination 24.63 (0.35) 24.07 (0.33) 1.97(TMSE), mean (SE) (-0.12,4.05)Hospital Anxiety and Depression 5.1 (0.72) 9.07 (0.32) 15.33Scale (HADs), mean (SE) (2.88,27.79)

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[Neurology International 2009; 1:e10] [page 39]

motor and sensory systems. Motor imitation isa complex cognitive function that incorporatesseveral stages, including motor observation(i.e., visual perception of ecologically validmovements), motor imagery, and motor execu-tion. Moreover it has been suggested thatmotor imagery might be beneficial to therecovery of motor functions after a stroke.

Most patients and caregivers prefer homerehabilitation, because of the opportunity to becloser to their families. This might reflect thestrong bonds of the extended family system,which could improve their quality of life.19 Paststudies have shown that rehabilitation inter-vention for stroke patients in the early phaseof recovery appears to accelerate gains in func-tion and quality of life.21 Additionally, well-organized rehabilitation services initiatedimmediately after a stroke can improve long-term outcomes. Prior studies have demonstrat-ed an improvement of function based on six toeight hours/day of constraint-induced exer-cise.22 On the contrary, our protocol had onehour/day only, with encouragement to practiceindependently. Additionally, the availability ofaudiovisual material is helpful as a resourcefor an intensive, motivated, and progressiveprogram.23

Neuropsychiatric disorders such as depres-sion and dementia after a stroke becomeincreasingly important in stroke survivors.24

The interaction between depression and neu-rological disease is complex. When depressionprecedes the onset of neurological disease, itis often unclear whether depression is the firstmanifestation of the illness or coincidentallypreceded the onset of an ensuring brain dis-ease. Previous studies on the prevalence ofdepression suggest that it varies widely, rang-ing from 7-76%.25 In Thailand, a one-yearcumulative incidence of depression after astroke was reported in 12% of patients.26 In ourstudy, at three months depression was foundin one patient (3.33%) in the interventiongroup, and in two patients (6.67%) in the con-trol group. This variation perhaps is due toinconsistent methodology.25 In our study, therewas an improvement in the Hospital Anxietyand Depression scores (HADs) in both groups,but the intervention group improved more. Thereason for this is not yet clear. The psychologi-cal support from home visits and family sur-roundings may have helped reduce depressionin the intervention group more than in thecontrol group. A previous study has reported acorrelation between improved quality of life,improved self-care ability, and decreaseddepression. In our study, depression is associ-ated also with low health-related quality of life.

A considerable decline in cognitive function,which can occur shortly after a stroke, hasbeen reported by several studies.27,28 In a recentstudy, about 30% of stroke patients developeddementia; stroke increased the risk of demen-

Figure 1. Study flow chart.

Figure 2. Post-treatment effects of the intervention for three months, adjusted for age,depression, and baseline measurement of outcome by the Barthel index.*p=0.001 (ANCOVA, significant at p<0.05).

Figure 3. Outcome of the modified rankin scale at three months, according to treatmentgroup.

68 subjects in registry (Thammasat University Hospital) were approached and screened for eligibility to enroll

60 consented and were eligible for study

30 randomizedto

intervention group

30 completed baselineand 3 months evaluation 2 died at home

after baseline assessment(cardiovascular causes)

28 completed baselineand 3 months evaluation

The Barthel index

Intervention group

Intervention group

Modified Rankin scale

Percentage of patients

Control group

Control group

Severe disability (4 or 5) Moderate disability (2 or 3) Minimum or no disability (0 or 1)

0 10 20 30 40 50 60 70 80 90 100

35.7164.29

906.673.33

0 1 2 3 4 months

1009080706050403020100

30 randomizedto usual care (control group)

- 4 severe aphasics or cognitive impairment- 3 lived outside area- 1 discharged to residential care

tia by 4-12 times. In our study, TMSE was notsignificantly different between the controlgroup and the intervention group. The reasonfor this is not yet clear. Dementia might havecommenced before the stroke. Barba et al.(2000)29 found a prevalence of dementia in11% of the elderly; but this study could havebeen for too short of a term for a thoroughanalysis. However, our study also has somelimitations. It was an efficacy study targeted atischemic stroke from middle cerebral arteryinfarction, and so the result may not be appli-cable to all stroke rehabilitation. In addition,patients with severe stroke were excluded. Theevaluation and intervention was done afterpatients had been discharged from the hospi-tal; therefore, each evaluation time point wasnot measured directly from the stroke onset.However, the average inpatient stay for eachgroup was approximately 10 days after acutestroke. Thus, the results are still applicable tothe time point in this study.

Our study demonstrated that early homerehabilitation service during the first three-month period in patients with ischemic strokeprovides a better outcome for improving func-tion and reducing disability compared to theusual rehabilitation practice.

The implementation of this program willcertainly enhance stroke survivors’ recoveryand quality of life. Further studies on the long-term outcomes and cost-effectiveness of thisintervention should be explored, however.

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