New Technology for Individualised, Intensive Training of Gait After Stroke Study I

Study Overview
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Brief Summary
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The overall purpose of this project is to establish the added value of training with the Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention programs after stroke. The aim of this study is to explore if HAL training when combined with conventional training in the subacute stage after stroke may accelerate the recovery of independence in walking when compared to conventional training only and if recovery is related to stroke lateralization?

Detailed Description
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Patients will be randomized using a block randomization by a nurse, who is not otherwise involved in the study, into either 1) HAL training in addition to the conventional program or 2) evidence based conventional gait training only. The block randomization will be designed so that an even number of patients with left and right sided hemiparesis will have been included in each group at the end of the study. Conventional training (including gait practice) will be performed according to current best practice (approximately 30-60 min per day, 5 days per week) and may include stepping, weight shifting, over ground walking as well as the use of a treadmill with/without body weight support (BWS). HAL training will be performed 4 days a week for 4 weeks (i.e. 16 sessions) with the single-leg version of HAL, primarily by use of the voluntary HAL-mode (CVC mode), on a treadmill with BWS. The therapist(s) educated in the HAL method will optimize the HAL settings for each individual during each session, in order to obtain a symmetrical gait pattern as close to normal gait as possible. Outcomes The primary outcome will be changes in the FAC-score during the intervention. FAC assesses activity in terms of independence in walking on a six-grade-ordinal-scale ranging from non-functional walking to independent walking outside. During the intervention assessments with the FAC will be performed weekly by the patients' physiotherapist responsible for conventional rehabilitation. This therapist will otherwise not be involved in the study. Secondary outcomes include aspects of body functions assessed by use of the NIH Stroke Scale, Albert's test, Fugl-Meyer Assessment(FMA-LE) and the Modified Ashworth Scale for the lower extremities. Activities and Participation will be assessed by use of Functional Ambulation Categories, 2 minutes walk test in self-preferred speed, Berg Balance Scale, Barthel Index and EQ5D. Patients' perception of training will be assessed by a study specific questionnaire. Adverse events (such as irritated skin, pain, falls) will be documented continuously in the study protocol according to a specific study form. Assessments will be performed 1) before and 2) after the intervention with 3) a follow up at 6 months.

Official Title
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New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study I

Conditions
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Stroke, Ambulation Difficulty, Hemiparesis

Intervention / Treatment
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* Device: Hybrid Assistive Limb (HAL)
* Other: Conventional gait training


Participation Criteria
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Eligibility Criteria
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Patients aged 18-67 will be recruited from 1) the University Department of Rehabilitation Medicine at Danderyd Hospital in Stockholm and 2) Sahlgrenska University Hospital in Gothenburg, where they are admitted to inpatient rehabilitation early after stroke. Inclusion criteria will be: less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. Functional Ambulation Categories (FAC) score 0-1), able to sit on a bench with or-without supervision at least 5 minutes; sufficient postural control to allow upright position in standing with aids and/or manual support; ability to understand training instructions as well as written and oral study information and to express informed consent; body size compatible with the HAL suit. Exclusion criteria include: contracture restricting gait movements at any lower limb joint; cardiovascular or other somatic condition incompatible with intensive gait training; and severe, contagious infections.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Assistive Limb (HAL)<br> | Device: Hybrid Assistive Limb (HAL)<br>* Intensive gait training with Hybrid Assistive Limb (HAL) is performed, 1 session/day, 4 days/week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective walking time with HAL).<br>|
| Active Comparator: Conventional gait training<br> | Other: Conventional gait training<br>* The conventional gait training is performed according to current best evidence based practice and may include over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support and training of gait function in activities of daily living.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Ambulation Categories (FAC) | Level of independence in walking, range 0-5 | Assessed at baseline, weekly, after 4 weeks of intervention and at 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) |  | At baseline | 
| Fugl-Meyer for Lower extremities | Sensory and motor function in lower extremities | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | 
| Albert's test | Spatial negelct | Assessed at baseline | 
| 2 Minutes Walk Test (MWT) | Walking | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | 
| Berg Balance scale | Balance | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | 
| Barthel Index | Independence in mobility and personal care | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | 
| Perception of the intervention | Interview, Study group using Hybrid Assistive Limb (HAL) only. | after 4 weeks of intervention | 
| Stroke Impact Scale (SIS) | Functioning and disability, Interview | Assessed at 6 months after intervention | 
| EQ-5D | Health Outcome | Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotics, Rehabilitation