Conditions
Conditions
Keywords
Exoskeleton, Stroke, Walking, Rehabilitation
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.
Interventions
DEVICEExoskeleton Program
Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.
OTHERUsual 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.
Sponsors
Heart and Stroke Foundation of Canada
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Walking ability - Functional Ambulation Category | Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | 6 months from admission | ActivPAL recording over 4 days |
| Days to independent walking | Discharge (generally 4-6 weeks, up to 8 weeks) | The number of days from admission until the participant is able to walk without any manual assistance from a therapist will be recorded. |
Countries
Canada
Outcome results
None listed