Exoskeleton for Post-Stroke Recovery of Ambulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Exoskeleton Program

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Usual Care Program

Intervention Type 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.

Interventions

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Exoskeleton Program

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

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No