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

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 main specific aims are: (i) to compare potential effects on functioning and disability of gait and mobility training long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation interventions to B) conventional rehabilitation interventions without HAL and to C) no intervention.

Detailed Description
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The effectiveness of the interventions will be assessed in terms aspects of body function, walking ability and endurance as well as level of activity in daily living and participation assessed at the end of intervention and at a 6 and 12 months follow-up. Intensive gait training with HAL is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time. To standardize the training procedure, training with HAL is performed on a treadmill and to enable body weight support. Body weight support is used to prevent falls and to unburden the weight of the suit (9 kg). The training program is performed by physiotherapists, trained in the HAL method and the study procedures. At the end of the 6 weeks, the physiotherapist that has been engaged in the patient's conventional training will perform 1-2 home visits to inform/educate the patient and those who are providing assistance to the patient in how the patient can make use of any gains in gait function during activities of daily living. The 1st control group will receive conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time. The 2nd control group will not receive an intervention. 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

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

Conditions
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Stroke, Ambulation Difficulty, Hemiparesis

Intervention / Treatment
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* Device: Hybrid Assistive Limb (HAL)
* Other: 1st control group
* Other: 2nd control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-10 years since stroke onset Able to walk but not independently, i.e. need of manual support or close supervision due to lower extremity paresis, FAC score 2-3 or FAC 4 combined with gait speed <0.8m/s according to 10 meter walk test, which corresponds to limitations in community ambulation (Bowden et al 2008) Ability to understand training instructions as well as written and oral study information and to express informed consent or by proxy Body size compatible with the HAL suit. Exclusion Criteria: Contracture restricting gait movements at any lower limb joint Cardiovascular or other somatic condition incompatible with intensive gait training Severe, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Study group Hybrid Assistive Limb (HAL)<br> | Device: Hybrid Assistive Limb (HAL)<br>* Intensive gait training with Hybrid Assistive Limb (HAL) is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time.<br>|
| Active Comparator: 1st control group<br> | Other: 1st control group<br>* Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.<br>|
| Active Comparator: 2nd control group<br> | Other: 2nd control group<br>* The 2nd control group will not receive an intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 min walk test | walking ability and endurance | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Scale for lower extremities | Sensory and motor function in lower extremities | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Modified Ashworth Scale | Spasticity | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Spasticity measured with Neuroflexor foot module | Spasticity | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Berg Balance Scale | Balance | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| 10 meters walk test | Walking | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| 2 minutes walk test | Walking | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Functional Ambulation Categories | Walking | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Borg Rating of Perceived Exertion Scale (RPE) | Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Montreal Cognitive Assessment |  | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Hospital anxiety and Depression Scale | Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Barthel Index | Independence in mobility and personal care | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Stroke Impact Scale | Functioning and disability, Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Physical activity in everyday life using SenseWear | Registers physical activity in everyday life | Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) | Stroke severity | Assessment at baseline | 
| Modified Ranking Scale | Interview | Assessment at baseline | 
| Body Mass Index |  | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Weight |  | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Height |  | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Blood pressure | Registered in everyday life | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| HbA1c | Blood test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Plasma lipid profile | Blood test | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Perception of the intervention | Interview. Study group using Hybrid Assistive Limb (HAL) only. | after 6 weeks of intervention | 
| Smoking | Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Alcohol | Interview | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Drug use | From medical records | Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention | 
| Health care consumption | From County Council | 12 month post intervention | 
| Stroke type and localization | From medical records | At baseline | 
| Dysexecutive Questionnaire | Filled in by significant other | At baseline | 

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