Suspended

TRAIL-RCTTRAIL: Telerehabilitation for Lower Extremity Recovery Post-Stroke

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What is being tested

TRAIL

+ EDUCATION

Other
Who is being recruted

Ischemic Stroke+20

+ Hemorrhagic Stroke

+ Behavior

Over 19 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2021
See protocol details

Summary

Principal SponsorUniversity of British Columbia
Study ContactElise A Wiley, MScMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTelerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial
NCT04908241
Principal SponsorUniversity of British Columbia
Study ContactElise A Wiley, MScMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

96 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Ischemic StrokeHemorrhagic StrokeBehaviorBrain DiseasesBrain InjuriesCardiovascular DiseasesCentral Nervous System DiseasesCerebral InfarctionBrain IschemiaCerebrovascular DisordersCraniocerebral TraumaInfarctionIschemiaMotor ActivityNecrosisNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesWounds and InjuriesTrauma, Nervous SystemBrain InfarctionStroke

Criteria

6 inclusion criteria required to participate
Has cognitive-communicative ability to participate, per clinical judgement

Has a caregiver, friend, or family member available to provide physical support during the assessment sessions

Able to provide consent

Can tolerate 50 minutes of activity (including rest breaks)

Show More Criteria

7 exclusion criteria prevent from participating
Not medically stable

Living in long-term care

Planned surgery that would preclude or affect participation in the protocol

Severe vision or hearing loss

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Active Comparator
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).

Study 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

Recruiting

University of British Columbia

Vancouver, CanadaOpen University of British Columbia in Google Maps
Recruiting

Dalhousie University

Nova Scotia, Canada
Recruiting

Riverview Health Centre

Winnipeg, Canada
Recruiting

Parkwood Institute

London, Canada
Suspended5 Study Centers