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Exoskeleton for Post-Stroke Recovery of Ambulation (ExStRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02995265
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Janice Eng, 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.

Condition or disease Intervention/treatment Phase
Conditions Device: Exoskeleton Program Other: Usual Care Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

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.




Primary Outcome Measures :
  1. Walking ability - Functional Ambulation Category [ Time Frame: Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks) ]

Secondary Outcome Measures :
  1. 5-Metre Walk Test (5MWT) [ Time Frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission ]
  2. 6-Minute Walk Test (6MWT) [ Time Frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission ]
  3. Berg Balance Scale (BBS) [ Time Frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission ]
  4. Health-related Quality of Life (SF-36) [ Time Frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission ]
  5. Depressive Symptoms (PHQ-9) [ Time Frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission ]
  6. Days to independent walking [ Time Frame: 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.

  7. 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 ]
  8. Cognition - Montreal Cognitive Assessment (MoCA) [ Time Frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission ]
  9. Blood pressure [ Time Frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission ]
  10. Functional Ambulation Category [ Time Frame: 6 Months from admission ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995265


Contacts
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Contact: Chihya Hung, MScPT 604-714-4108 chihya.hung@ubc.ca
Contact: Riley Louie, MPT 604-714-4108 r.louie@alumni.utoronto.ca

Locations
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Canada, Alberta
Glenrose Rehabilitation hospital Terminated
Edmonton, Alberta, Canada, T5B0b7
Canada, British Columbia
GF Strong Rehab Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@ubc.ca   
Canada, Ontario
Parkwood Institute Recruiting
London, Ontario, Canada, N6C0A7
Contact: Mitch Longval, BSc       Mitch.Longval@sjhc.london.on.ca   
Principal Investigator: Robert Teasell, PhD         
Sponsors and Collaborators
University of British Columbia
Heart and Stroke Foundation of Canada
Investigators
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Principal Investigator: Janice J Eng, PhD Department of Physical Therapy, University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janice Eng, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02995265    
Other Study ID Numbers: H15-01339
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Janice Eng, University of British Columbia:
Exoskeleton
Stroke
Walking
Rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases