Exoskeleton for Post-Stroke Recovery of Ambulation

Study Overview
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Brief Summary
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To determine the effect of using a robotic exoskeleton to allow walking practice after stroke, compared to usual physiotherapy care, on recovery of walking ability and secondary outcomes.

Detailed Description
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Participants admitted to inpatient stroke rehabilitation for physiotherapy services will be randomly assigned to either the Exoskeleton Program or Usual Care Program. Individuals in the Exoskeleton Program will have their usual physiotherapy sessions replaced with the exoskeleton intervention. The exoskeleton will allow standing and walking from the first sessions in rehabilitation, as the exoskeleton provides the physical support to allow walking in full weight-bearing without being limited by therapist fatigue and lifting requirements. Individuals in the Usual Care Program will receive standard physiotherapy care, which is individualized and hands-on with their therapist to regain walking, mobility, and independent function. Both groups will be conducted 3-5 days a week, 30-60 minutes per session until discharge (to a maximum of 8 weeks). Participants will be assessed at baseline, discharge, and 6-months after starting rehabilitation.

Official Title
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Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2

Conditions
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Conditions

Intervention / Treatment
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* Device: Exoskeleton Program
* Other: Usual Care Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been admitted to a hospital unit for stroke treatment Stroke within last 3 months One-sided hemiparesis 19 years or older Requires 2-person assist to walk Able to communicate and follow instructions Prescribed to receive physiotherapy care Exclusion Criteria: Stroke of non-vascular origin (e.g. tumour, infection) Significant musculoskeletal or other neurological condition Co-morbidities that would preclude activity Pregnant Unable to walk prior to stroke <60 inches or >74 inches in height >220 pounds in weight Joint contractures or spasticity that would limit safe use of the Ekso exoskeleton

Ages Eligible for Study
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Minimum Age: 19 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: Exoskeleton Program<br>Exoskeleton-based walking rehabilitation until discharge (or to a maximum of 8 weeks), 3 - 5 days a week for 30-60 minutes per session. Participants will be assessed upon admission to the study, discharge, as well as at 6 months post-stroke. The exoskeleton will allow standing and walking with full weight bearing from the first sessions in rehabilitation. | Device: Exoskeleton Program<br>* Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.<br>|
| Active Comparator: Usual Care Program<br>Standard physiotherapy stroke rehabilitation which includes training for regaining walking as well as other functional tasks, 3 - 5 days a week for 30-60 minutes per session until discharge (or to a maximum of 8 weeks). Participants will be assessed upon admission to the study, discharge, as well as at 6 months post-stroke. | Other: Usual Care Program<br>* Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking ability - Functional Ambulation Category |  | Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-Metre Walk Test (5MWT) |  | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission | 
| 6-Minute Walk Test (6MWT) |  | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission | 
| Berg Balance Scale (BBS) |  | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission | 
| Health-related Quality of Life (SF-36) |  | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission | 
| Depressive Symptoms (PHQ-9) |  | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission | 
| Days to independent walking | The number of days from admission until the participant is able to walk without any manual assistance from a therapist will be recorded. | Discharge (generally 4-6 weeks, up to 8 weeks) | 
| Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower) |  | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission | 
| Cognition - Montreal Cognitive Assessment (MoCA) |  | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission | 
| Functional Ambulation Category |  | 6 Months from admission | 
| Daily step count | ActivPAL recording over 4 days | 6 months from admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exoskeleton, Stroke, Walking, Rehabilitation