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Telerehabilitation for Stroke (TRAIL-RCT Trial)
N/A
Recruiting
Led By Brodie Sakakibara, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to walk ≥10 meters with or without a gait aid and without physical assistance of another person
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Awards & highlights
TRAIL-RCT Trial Summary
This trial will compare two programs to help improve lower extremity function for people with stroke in Canada.
Who is the study for?
This trial is for adults over 19, within a year of having a stroke that affected their leg movement. They must be able to walk at least 10 meters, handle 50 minutes of activity with breaks, and have someone to help during sessions. It's not for those in long-term care or currently in similar rehab.Check my eligibility
What is being tested?
The TRAIL-RCT compares a 4-week lower extremity telerehabilitation program aimed at improving leg function after stroke against an education program focusing on the same outcomes across Canada. The study measures clinical results, quality of life, and healthcare use.See study design
What are the potential side effects?
Since this trial involves rehabilitation exercises and educational programs rather than medication, side effects are minimal but may include typical exercise-related issues such as muscle soreness or fatigue.
TRAIL-RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk 10 meters or more by myself, with or without help from a device.
TRAIL-RCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline Timed Up and Go (TUG) at 4 weeks
Secondary outcome measures
30 second Sit to Stand
Activities-Specific Balance (ABC) Scale
Functional Reach
+5 moreOther outcome measures
Feasibility Indicator: Appropriateness of Randomization Process
Pregnancy Outcome
Feasibility Indicator: Ease of Using Equipment
+10 moreTRAIL-RCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TRAILExperimental Treatment1 Intervention
TRAIL is a 4-week progressive exercise and self-management intervention for lower extremity recovery delivered by a trained registered physical therapist, in a 2:1 participant-to-therapist ratio. Each participant grouping will receive two telerehabilitation sessions (60-90 minutes) each week for 4 weeks (total 8-12 hours).
Group II: EDUCATIONActive Control1 Intervention
The EDUCATION control arm is a 4-week education program focusing on stroke knowledge and risk factors. It will be delivered by health professionals who have experience working with individuals with stroke, knowledge of chronic disease self-management (e.g. physical or occupational therapists, nurses, kinesiologists), and who have completed study-specific training on the EDUCATION program
Participants will receive video conferencing sessions with the same schedule and 2:1 participant-to-coach ratio as TRAIL. Each participant grouping will receive two educational telerehabilitation sessions (60-90 minutes) each week for 4 weeks (total 8-12 hours).
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,920 Total Patients Enrolled
32 Trials studying Stroke
26,549 Patients Enrolled for Stroke
McMaster UniversityOTHER
880 Previous Clinical Trials
2,597,732 Total Patients Enrolled
21 Trials studying Stroke
41,641 Patients Enrolled for Stroke
Brodie Sakakibara, PhDPrincipal InvestigatorUniversity of British Columbia
4 Previous Clinical Trials
387 Total Patients Enrolled
1 Trials studying Stroke
32 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant condition affecting my muscles, bones, or nerves.I can be active for 50 minutes with breaks.I am 19 or older and had a stroke less than a year ago, affecting my leg.I have a condition or symptom that greatly affects my leg function.I have someone to help me during my assessment sessions.I have severe vision or hearing loss.I don't have any upcoming surgeries that would interfere with this study.I can walk 10 meters or more by myself, with or without help from a device.My health condition is not stable.I am in a stroke rehab program for leg training.I can understand and communicate about my health condition.
Research Study Groups:
This trial has the following groups:- Group 1: EDUCATION
- Group 2: TRAIL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are actively involved in this clinical trial?
"Participants are being accepted at Dalhousie University in Nova Scotia, Halifax, Riverview Health Centre in Winnipeg Manitoba and Parkwood Institute in London British Columbia as well as five other locations."
Answered by AI
What is the maximum number of participants accepted for this research endeavor?
"Affirmative. As per the information available on clinicaltrials.gov, this research project is actively seeking participants; it was first posted in November 8th 2021 and was most recently updated on March 1st 2022. Its goal is to enrol 96 patients from 5 separate medical centres."
Answered by AI
Is enrollment for this trial still available?
"Affirmative. As per clinicaltrials.gov, this research trial is currently enrolling participants, having been made available on the 8th of November 2021 and most recently updated in March 1st 2022. The protocol is looking for 96 patients to be recruited from 5 distinct sites."
Answered by AI
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