Exoskeleton for Post-Stroke Recovery of Ambulation

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Usual Care Program	Usual Care Program	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.
Exoskeleton Program	Exoskeleton Program	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.

Primary Outcome Measures

Name	Time	Method
Walking ability - Functional Ambulation Category	Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)

Secondary Outcome Measures

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

Locations (3): Parkwood Institute
🇨🇦
London, Ontario, Canada
Glenrose Rehabilitation hospital
🇨🇦
Edmonton, Alberta, Canada
GF Strong Rehab Centre
🇨🇦
Vancouver, British Columbia, Canada