Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton Program | Device | Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking ability - Functional Ambulation Category | Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janice J Eng, PhD | Department of Physical Therapy, University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenrose Rehabilitation hospital | Edmonton | Alberta | T5B0b7 | Canada | ||
| GF Strong Rehab Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34694189 | Derived | 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. | |
| 34629104 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004194 | Disease |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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 |
| 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. | Discharge (generally 4-6 weeks, up to 8 weeks) |
| Motor impairment/recovery of the lower extremity (Fugl-Meyer Lower) | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission |
| Cognition - Montreal Cognitive Assessment (MoCA) | Discharge (generally 4-6 weeks, up to 8 weeks), 6 months from admission |
| Functional Ambulation Category | 6 Months from admission |
| Daily step count | ActivPAL recording over 4 days | 6 months from admission |
| Vancouver |
| British Columbia |
| V5Z 2G9 |
| Canada |
| Parkwood Institute | London | Ontario | N6C0A7 | Canada |
| 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. |
| 31992219 | 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. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |