Telerehabilitation program to improve lower limb recovery after stroke
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial
This study is testing a new online rehabilitation program to see if it can help stroke survivors improve their leg function better than a standard education program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 5 sites (Vancouver, British Columbia and 4 other locations) |
| Trial ID | NCT04908241 on ClinicalTrials.gov |
What this trial studies
This study compares a 4-week telerehabilitation program aimed at enhancing lower extremity function in stroke survivors with a 4-week education program focused on attention control. The trial targets community-dwelling adults who have experienced a stroke within the last year and are experiencing lower extremity hemiparesis. By utilizing technology, the telerehabilitation approach seeks to provide accessible rehabilitation options, especially in light of the COVID-19 pandemic. The effectiveness of this intervention will be assessed through clinical outcomes, quality of life measures, and healthcare resource utilization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who are within 12 months post-stroke and can walk at least 10 meters with or without assistance.
Not a fit: Patients currently in formal rehabilitation programs or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve mobility and quality of life for stroke survivors.
How similar studies have performed: Previous studies have shown promise for telerehabilitation in stroke recovery, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥19 years of age, ≤12 months post-stroke with lower extremity hemiparesis * Able to walk ≥10 meters with or without a gait aid and without physical assistance of another person * Can tolerate 50 minutes of activity (including rest breaks) * Has cognitive-communicative ability to participate, per clinical judgement * Able to provide consent * Has a caregiver, friend, or family member available to provide physical support during the assessment sessions Exclusion Criteria: * Currently participating in formal in- or out-patient stroke rehabilitation focusing on lower extremity training * Living in long-term care * Severe vision or hearing loss * Significant musculoskeletal or other neurological conditions * Not medically stable * Comorbidities (e.g. limb amputation), pain or other symptoms that significantly impact lower extremity function * Planned surgery that would preclude or affect participation in the protocol
Where this trial is running
Vancouver, British Columbia and 4 other locations
- University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)
- Dalhousie University — Nova Scotia, Halifax, Canada (Recruiting)
- Riverview Health Centre — Winnipeg, Manitoba, Canada (Recruiting)
- Parkwood Institute — London, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Brodie Sakakibara, PhD — University of British Columbia
- Study coordinator: Elise A Wiley, MSc
- Email: wileye@mcmaster.ca
- Phone: (289) 214-1569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.