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

Exoskeleton for Post-Stroke Recovery of Ambulation

Sponsors

Lead sponsor: University of British Columbia

Collaborator: Heart and Stroke Foundation of Canada

Source University of British Columbia
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.

Overall Status Recruiting
Start Date May 1, 2017
Completion Date December 31, 2020
Primary Completion Date May 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Walking ability - Functional Ambulation Category Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)
Secondary Outcome
Measure 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 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
Blood pressure Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Functional Ambulation Category 6 Months from admission
Enrollment 40
Condition
Intervention

Intervention type: Device

Intervention name: Exoskeleton Program

Description: Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.

Arm group label: Exoskeleton Program

Intervention type: Other

Intervention name: Usual Care Program

Description: Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.

Arm group label: Usual Care Program

Eligibility

Criteria:

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

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Janice J Eng, PhD Principal Investigator Department of Physical Therapy, University of British Columbia
Overall Contact

Last name: Chihya Hung, MScPT

Phone: 604-714-4108

Email: [email protected]

Location
facility status
Glenrose Rehabilitation hospital | Edmonton, Alberta, T5B0b7, Canada Terminated
GF Strong Rehab Centre | Vancouver, British Columbia, V5Z 2G9, Canada Recruiting Chihya Hung, MScPT 604-714-4108 [email protected]
Parkwood Institute | London, Ontario, N6C0A7, Canada Recruiting Mitch Longval, BSc [email protected] Robert Teasell, PhD Principal Investigator
Location Countries

Canada

Verification Date

December 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of British Columbia

Investigator full name: Janice Eng

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Exoskeleton Program

Arm group type: Experimental

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.

Arm group label: Usual Care Program

Arm group type: Active Comparator

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.

Acronym ExStRA
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov