Clinical trial NCT02995265: Exoskeleton for Post-Stroke Recovery of Ambulation
Official title: Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditions
Keywords: Exoskeleton
Stroke
Walking
Rehabilitation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2016-12-16
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Walking ability - Functional Ambulation Category
timeFrame: Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)
Secondary outcomes:
measure: 5-Metre Walk Test (5MWT)
timeFrame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: 6-Minute Walk Test (6MWT)
timeFrame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Berg Balance Scale (BBS)
timeFrame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Health-related Quality of Life (SF-36)
timeFrame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Depressive Symptoms (PHQ-9)
timeFrame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Days to independent walking
timeFrame: Discharge (generally 4-6 weeks, up to 8 weeks)
measure: Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)
timeFrame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Cognition - Montreal Cognitive Assessment (MoCA)
timeFrame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
measure: Functional Ambulation Category
timeFrame: 6 Months from admission
measure: Daily step count
timeFrame: 6 months from admission
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation hospital
state: Alberta
city: Vancouver
country: Canada
facility: GF Strong Rehab Centre
state: British Columbia
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
Study officials:
affiliation: Department of Physical Therapy, University of British Columbia
name: Janice J Eng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.