Exoskeleton for Post-Stroke Recovery of Ambulation (ExStRA)

University of British Columbia

Status: Completed

Conditions: Conditions

Treatments: Device: Exoskeleton Program; Other: Usual Care Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02995265

H15-01339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Exoskeleton Program

Experimental group

Description:

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.

Treatment:

Device: Exoskeleton Program

Usual Care Program

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care Program