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Exoskeleton for Post-Stroke Recovery of Ambulation (ExStRA)

Primary Purpose

Conditions

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exoskeleton Program
Usual Care Program
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conditions focused on measuring Exoskeleton, Stroke, Walking, Rehabilitation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Glenrose Rehabilitation hospital
  • GF Strong Rehab Centre
  • Parkwood Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exoskeleton Program

Usual Care Program

Arm 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.

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.

Outcomes

Primary Outcome Measures

Walking ability - Functional Ambulation Category

Secondary Outcome Measures

5-Metre Walk Test (5MWT)
6-Minute Walk Test (6MWT)
Berg Balance Scale (BBS)
Health-related Quality of Life (SF-36)
Depressive Symptoms (PHQ-9)
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.
Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)
Cognition - Montreal Cognitive Assessment (MoCA)
Functional Ambulation Category
Daily step count
ActivPAL recording over 4 days

Full Information

First Posted
December 7, 2016
Last Updated
August 27, 2020
Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02995265
Brief Title
Exoskeleton for Post-Stroke Recovery of Ambulation
Acronym
ExStRA
Official Title
Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 8, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conditions
Keywords
Exoskeleton, Stroke, Walking, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton Program
Arm Type
Experimental
Arm 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 Title
Usual Care Program
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Exoskeleton Program
Intervention Description
Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.
Intervention Type
Other
Intervention Name(s)
Usual Care Program
Intervention 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.
Primary Outcome Measure Information:
Title
Walking ability - Functional Ambulation Category
Time Frame
Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)
Secondary Outcome Measure Information:
Title
5-Metre Walk Test (5MWT)
Time Frame
Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Title
6-Minute Walk Test (6MWT)
Time Frame
Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Title
Berg Balance Scale (BBS)
Time Frame
Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Title
Health-related Quality of Life (SF-36)
Time Frame
Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Title
Depressive Symptoms (PHQ-9)
Time Frame
Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Title
Days to independent walking
Description
The number of days from admission until the participant is able to walk without any manual assistance from a therapist will be recorded.
Time Frame
Discharge (generally 4-6 weeks, up to 8 weeks)
Title
Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)
Time Frame
Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Title
Cognition - Montreal Cognitive Assessment (MoCA)
Time Frame
Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Title
Functional Ambulation Category
Time Frame
6 Months from admission
Title
Daily step count
Description
ActivPAL recording over 4 days
Time Frame
6 months from admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice J Eng, PhD
Organizational Affiliation
Department of Physical Therapy, University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glenrose Rehabilitation hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5B0b7
Country
Canada
Facility Name
GF Strong Rehab Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C0A7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34629104
Citation
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.
Results Reference
derived
PubMed Identifier
31992219
Citation
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.
Results Reference
derived

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Exoskeleton for Post-Stroke Recovery of Ambulation

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