Exoskeleton for Post-Stroke Recovery of Ambulation (ExStRA)

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

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.

Study Overview

• Status: Completed
• Conditions: Conditions
• Intervention / Treatment: Device: Exoskeleton Program; Other: Usual Care Program

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5B0b7
      • Glenrose Rehabilitation Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2G9
      • GF Strong Rehab Centre
  • Ontario
    • London, Ontario, Canada, N6C0A7
      • Parkwood Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Exoskeleton Program; Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.
Active Comparator: 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.	Other: Usual Care Program; Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Heart and Stroke Foundation of Canada
• Investigators: Principal Investigator: Janice J Eng, PhD, Department of Physical Therapy, University of British Columbia

Publications and helpful links

General Publications

• Louie DR, Mortenson WB, Durocher M, Schneeberg A, Teasell R, Yao J, Eng JJ. Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial. J Neuroeng Rehabil. 2021 Oct 10;18(1):149. doi: 10.1186/s12984-021-00942-z.
• Louie DR, Mortenson WB, Durocher M, Teasell R, Yao J, Eng JJ. Exoskeleton for post-stroke recovery of ambulation (ExStRA): study protocol for a mixed-methods study investigating the efficacy and acceptance of an exoskeleton-based physical therapy program during stroke inpatient rehabilitation. BMC Neurol. 2020 Jan 28;20(1):35. doi: 10.1186/s12883-020-1617-7.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): February 8, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Walking; Exoskeleton
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H15-01339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes