HAL FOR TRAINING OF GAIT EARLY AFTER STROKE

Anneli Wall, Reg. Physiotherapist, MSc, PhD student Karolinska Institutet , Department of Clinical Sciences, Danderyd Hospital, KI DS University Department of Rehabilitation Medicine Danderyd Hospital

Background

• Limited gait function is common after stroke

• To regain walking ability is often a main goal

• Early, intensive training improves the final outcome

• Electromechanical gait machines may provide this

Gait machines

Gait machines

HAL - Saftey and Feasibility

• 8 patients with stroke > 8 weeks

• 5 days per week

• Autonomous Control and Voluntary Control modes was used.

• No adverse events

• HAL was feasible and safe

Phase I

Nilsson,A.,Vreede,K.S.,Haglund,V.,Kawamoto,H.,Sankai,Y.,Borg,J. (2014). Gait training early after stroke with a new exoskeleton—the hybrid assistive limb: a study of safety and feasibility. J. Neuroeng.Rehabil. 11:92. Grants from: Tsukuba University, Promobilia and STROKE-riksförbundet, Robotdalen.

Authors Diagnosis Included (n) Completed (n)

Kawamoto et al, 2013 Stroke 16 16

Maeshima et al, 2011 Stroke 16 16

Nilsson et al, 2014 Stroke 8 8

Ueba et al, 2013 Stroke 22 6

Watanabe et al, 2014 Stroke 32 22 (11 in each group)

Aach et al, 2014 SCI 8 8

Kubota et al, 2013

Stroke (n= 2) SCI (n=8),

Musculoskeletal diseases (n=4)

Other diseases (n=14)

38 32

Wall A, Borg J and Palmcrantz S (2015). Clinical application of the Hybrid Assistive Limb (HAL) for gait training - a systematic review. Front. Syst. Neurosci. 9:48.

Systematic review confirms: feasibility and safety

Gait training early after stroke – a comparison between training with the exoskeleton Hybrid Assistive Limb and conventional gait training Anneli Wall, PT, MSc, PhD student Susanne Palmcrantz, PT, PhD Vera Häglund, MD Disa Sommerfeld, PT , Associate Professor Katarina Skough Vreede, PT , PhD Jörgen Borg, MD, Professor

Grants from: Tsukuba University, Promobilia, STROKE-riksförbundet, ALF

Phase II

Methods • Inclusion criteria: - less than 8 weeks since stroke onset - inability to walk independently due to lower extremity paresis (FAC 0-1) - sufficient postural control to allow upright position in standing - body size compatible with the HAL suit

Phase II

Methods • Inclusion criteria: - less than 8 weeks since stroke onset - inability to walk independently due to lower extremity paresis (FAC 0-1) - sufficient postural control to allow upright position in standing - body size compatible with the HAL suit • Exclusion criteria: - contractures, cardiovascular or other somatic condition restricting

intensive gait training

Phase II

Training program HAL group Control group

1 session per day 4 days per week 4 weeks Time for each session is individualised but does not exceed 60 min/session (effective time) Training with HAL is performed in combination with body-weight support system and on a treadmill

Conventional gait training, performed according to current practice 5 days a week Approximately 30-60 minutes/session May include use of a treadmill and body weight support

Conventional gait training is offered to both study groups

Phase II

Data Collection ICF* Components

Assessments Baseline Post

intervention 6 months

post stroke

Function • NIH Stroke Scale

• Albert’s test

• Fugl-Meyer Scale

• Modified Ashworth Scale

• Laboratory Gait analysis

- Gait Deviation Index (GDI) and the GDI-kinetic

• Study specific questionnaire

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Activities • Functional Ambulation Categories

• 2 minutes walk test in self-preferred speed

• Berg Balance Scale

• Barthel Index

X

X

X

X

X

X

X

X

X

X

X

X

Activities and participation

• Stroke Impact Scale X

Environmental factor

• Semi-structured interview X

* ICF - International Classification of Functioning, Disability and Health

Phase II

Laboratory gait analysis Phase II

Laboratory gait analysis -motion capture system, force plates

Phase II

Laboratory gait analysis - wireless surface electromyography

Phase II

Baseline Characteristics HAL group Control Group

Number of patients 8 11

Age in mean (SD) 52.1 (12.9) 57 (11.4)

Gender (men/women) 6/2 6/5

Diagnosis (infarct/hemorrhage) 6/2 6/5

Paretic side (left/right) 7/1 6/5

Days from stroke to baseline in mean 30 36

Presence of sensory loss in LE, according to Fugl-Meyer Assessment 8 9

Fugl-Meyer Assessment for LE, motor score, reflexes excluded, 0-28p median (IQR)

3.5 (1.5-8.25)

6.5 (0.75-15.5)

Phase II

Baseline Post

intervention

6 months

post stroke

HAL

(n=8)

Control

(n=11)

HAL

(n=8)

Control

(n=10)

HAL

(n=7)

Control

(n=6)

FAC median

(IQR)

0

(0-1)

0

(0-1)

2

(1.75-3)

2 ,5

(1.25-3)

5

(4-5)

4

(3.25-4.75)

Interim analysis Phase II

Baseline Post

intervention

6 months

post stroke

HAL

(n=8)

Control

(n=11)

HAL

(n=8)

Control

(n=10)

HAL

(n=7)

Control

(n=6)

FAC median

(IQR)

0

(0-1)

0

(0-1)

2

(1.75-3)

2 ,5

(1.25-3)

5

(4-5)

4

(3.25-4.75)

Interim analysis

Score 4

Independent, Level Surfaces Only Independent on level surfaces but requires

supervision/physical assistance in stairs, inclines, or unlevel surfaces.

Phase II

Score 5

Independent, Level and Non-Level Surfaces

Independent on unlevel and level surfaces, stairs, and inclines.

Baseline Post

intervention

6 months

post stroke

HAL

(n=8)

Control

(n=11)

HAL

(n=8)

Control

(n=10)

HAL

(n=7)

Control

(n=6)

FAC median

(IQR)

0

(0-1)

0

(0-1)

2

(1.75-3)

2 ,5

(1.25-3)

5

(4-5)

4

(3.25-4.75)

Interim analysis Phase II

Score 4

Independent, Level Surfaces Only Independent on level surfaces but requires

supervision/physical assistance in stairs, inclines, or unlevel surfaces.

Score 5

Independent, Level and Non-Level Surfaces

Independent on unlevel and level surfaces, stairs, and inclines.

Baseline Post

intervention

6 months

post stroke

HAL

(n=8)

Control

(n=11)

HAL

(n=8)

Control

(n=10)

HAL

(n=7)

Control

(n=6)

2 Minutes Walk Test (meters)

mean

(SD)

5.6

(5.2)

7.7

(13.4)

35.9

(27.4)

40.8

(42.7)

81.9

(56.6)

78.6

(58.5)

Interim analysis Phase II

Baseline Post

Intervention

6 months

post stroke

HAL

(n=8)

Control

(n=11)

HAL

(n=8)

Control

(n=10)

HAL

(n=7)

Control

(n=6)

Berg Balance scale (0-56 p)

median

(IQR)

7.5

(4.8-10.5)

8

(5-14)

18.5

(10-33.3)

20

(14-33.3)

49

(45-52.5)

40

(28-51.3)

Interim analysis Phase II

Baseline Post

intervention

6 months

post stroke

HAL

(n=8)

Control

(n=11)

HAL

(n=8)

Control

(n=10)

HAL

(n=7)

Control

(n=6)

Berg Balance scale (0-56 p)

median

(IQR)

7.5

(4.8-10.5)

8

(5-14)

18.5

(10-33.3)

20

(14-33.3)

49

(45-52.5)

40

(28-51.3)

Interim analysis Phase II

Score of < 45 indicates greater risk of falling

Conclusion Phase II

• HAL shows continued feasibility • HAL allows intensive gait training to start early after stroke • Indicates good results for HAL group and most so at 6 months • Data from the laboratory gait analysis will go in depth on patients walking characteristics

Future study- Phase III • A multicentre, randomized, controlled phase III

study to evaluate HAL training after stroke • Starting in late 2015 • 3 study sites in Sweden

- Danderyd University Hospital, Stockholm - Sahlgrenska University Hospital, Gothenburg - Norrland University Hospital, Umeå

• Two parts - Early after stroke (4-7 weeks), 108 pat - Late/chronic stage (12-48 months), 162 pat

Grants from the Swedish Research Council (VR)

Phase III

Thank you! Researchers Stockholm study group Anneli Wall, RPT, MSc, PhD student Susanne Palmcrantz, RPT, PhD Katarina Vreede, RPT, PhD Disa Sommerfeld, RPT, Associate Professor Lanie Gutierrez-Farewik,Associate Professor Vera Häglund, MD Jörgen Borg, Professor In collaboration with Professor Sankai’s group, Tsukuba Univerity, Japan

anneli.wall@ki.se