Exoskeleton for Post-Stroke Recovery of Ambulation

NCT02995265 | Completed DMC FDA Device

• 1 other identifier: H15-01339
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Conditions

Keywords

Exoskeleton; Stroke; Walking; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Walking ability - Functional Ambulation Category

  Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)

Secondary Outcomes (10)

• 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

Study Arms (2)

Exoskeleton Program

EXPERIMENTAL

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

Usual Care Program

ACTIVE COMPARATOR

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

Interventions

Exoskeleton Program DEVICE

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

Exoskeleton Program

Usual Care Program OTHER

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

Usual Care Program

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been admitted to a hospital unit for stroke treatment
• Stroke within last 3 months
• One-sided hemiparesis
• years or older
• Requires 2-person assist to walk
• Able to communicate and follow instructions
• Prescribed to receive physiotherapy care

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (3)

Glenrose Rehabilitation hospital

Edmonton, Alberta, T5B0b7, Canada

Location

GF Strong Rehab Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Parkwood Institute

London, Ontario, N6C0A7, Canada

Location

Related Publications (3)

• Louie DR, Mortenson WB, Lui M, Durocher M, Teasell R, Yao J, Eng JJ. Patients' and therapists' experience and perception of exoskeleton-based physiotherapy during subacute stroke rehabilitation: a qualitative analysis. Disabil Rehabil. 2022 Dec;44(24):7390-7398. doi: 10.1080/09638288.2021.1989503. Epub 2021 Oct 25.

  PMID: 34694189 DERIVED

• 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.

  PMID: 34629104 DERIVED

• 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.

  PMID: 31992219 DERIVED

MeSH Terms

Conditions

Disease; Stroke

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Janice J Eng, PhD

  Department of Physical Therapy, University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 16, 2016
• Study Start: May 1, 2017
• Primary Completion: February 8, 2020
• Study Completion: June 30, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)