TRAIL-RCTTRAIL: Telerehabilitation for Lower Extremity Recovery Post-Stroke
TRAIL
+ EDUCATION
Ischemic Stroke+20
+ Hemorrhagic Stroke
+ Behavior
Treatment Study
Summary
Study start date: November 8, 2021
Actual date on which the first participant was enrolled.Stroke survival rates are high, but many survivors experience motor impairments that affect their daily activities and put a strain on healthcare resources. To help improve lower extremity recovery post-stroke, a telerehabilitation program called TRAIL has been developed. TRAIL is an exercise program that uses technology to provide real-time therapist instruction and guidance. A previous feasibility study showed potential for TRAIL to improve lower extremity function in stroke survivors. Now, a full-scaled randomized controlled trial, TRAIL-RCT, is proposed to further study the program's effectiveness. This study is important as it aims to address the unmet needs for lower extremity rehabilitation after stroke and provide accessible rehabilitation, especially in light of the COVID-19 pandemic. The TRAIL-RCT study compares the TRAIL program to an attention-controlled education program (EDUCATION) for individuals within 12 months post-stroke. The primary goal is to evaluate functional mobility improvement after 4 weeks, measured by the Timed Up and Go test. Secondary goals include assessing lower extremity strength, functional balance, motor impairment, and balance self-efficacy. The study also evaluates health economic outcomes, such as health-related quality of life and health resources and costs. It is hypothesized that the TRAIL program will lead to greater improvements in all these areas compared to the EDUCATION program. Additionally, the study will evaluate the feasibility of a subsequent larger multisite implementation of the TRAIL program.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.96 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 19 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Dalhousie University
Nova Scotia, CanadaRiverview Health Centre
Winnipeg, CanadaParkwood Institute
London, Canada