ConditionsExStRANCT02995265
Exoskeleton for Post-Stroke Recovery of Ambulation
A study testing Exoskeleton Program in people with Conditions, run by University of British Columbia at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Conditions
- What is being tested?
- Exoskeleton Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesCanada
- Study dates
- 1 May 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Glenrose Rehabilitation hospital
Edmonton, Alberta, T5B0b7
Parkwood Institute
London, Ontario, N6C0A7
GF Strong Rehab Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2
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.
Read the 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.
- Conditions
- Conditions
- Being tested
- Exoskeleton Program, Usual Care Program
- Keywords
- Exoskeleton, Stroke, Walking, Rehabilitation
- Medical subject headings
- Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton ProgramDevice
Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.
Usual Care ProgramOther
Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking ability - Functional Ambulation Category
Measured: Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)
Secondary outcomes (10)
5-Metre Walk Test (5MWT)
Measured: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
6-Minute Walk Test (6MWT)
Measured: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Berg Balance Scale (BBS)
Measured: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Health-related Quality of Life (SF-36)
Measured: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Depressive Symptoms (PHQ-9)
Measured: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
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.
Measured: Discharge (generally 4-6 weeks, up to 8 weeks)
Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower)
Measured: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Cognition - Montreal Cognitive Assessment (MoCA)
Measured: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Functional Ambulation Category
Measured: 6 Months from admission
Daily step count
ActivPAL recording over 4 days
Measured: 6 months from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start1 May 2017
- Primary completion8 Feb 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ConditionsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Janice Eng, University of British Columbia
- Investigators
- Janice J Eng, PhD, Principal investigator, Department of Physical Therapy, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995265
- Sponsor's protocol ID
- H15-01339
- Acronym
- ExStRA
- Status last verified
- Aug 2020
- First submitted
- 7 Dec 2016
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34694189Louie 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.
PubMed 34629104Louie 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.
PubMed 31992219
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Robotic Exoskeleton to Promote Walking Recovery After Stroke - Phase 2
- ClinicalTrials.gov ID
- NCT02995265
- Acronym / sponsor ID
- ExStRA / H15-01339
- Conditions
- Conditions
- Keywords
- Exoskeleton, Stroke, Walking, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 1 May 2017 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton Program | Experimental | Device: Exoskeleton ProgramExoskeleton-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. |
| Usual Care Program | Active comparator | Other: Usual Care ProgramStandard 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exoskeleton ProgramSubjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability. | Device | Exoskeleton Program |
| Usual Care ProgramSubjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist. | Other | Usual Care Program |
Primary outcome
Walking ability - Functional Ambulation Category
Time frame: Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)
10 secondary outcomes
5-Metre Walk Test (5MWT)
Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
6-Minute Walk Test (6MWT)
Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Berg Balance Scale (BBS)
Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Health-related Quality of Life (SF-36)
Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Depressive Symptoms (PHQ-9)
Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Days to independent walking
Time frame: Discharge (generally 4-6 weeks, up to 8 weeks)
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
Cognition - Montreal Cognitive Assessment (MoCA)
Time frame: Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission
Functional Ambulation Category
Time frame: 6 Months from admission
Daily step count
Time frame: 6 months from admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Derived from this study: PubMed 34694189Louie 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.
- Derived from this study: PubMed 34629104Louie 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.
- Derived from this study: PubMed 31992219Louie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice J Eng, PhD principal investigator
Department of Physical Therapy, University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton Program in people with Conditions, run by University of British Columbia at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking ability - Functional Ambulation Category (time frame: Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995265, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.