Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT)
NCT ID: NCT04908241
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
96 participants
INTERVENTIONAL
2021-11-08
2024-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke
NCT04265664
Optimizing Patient Adherence to Stroke Rehabilitation Treatment
NCT04440215
Ankle Tracking Training in Stroke
NCT01298583
Fitness Intervention Trial for Stroke
NCT00786045
A Comparison of Two Intensive Walking Training Interventions in Community Dwelling Individuals With History of Stroke
NCT00561405
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The rapid growth in Internet use and personal mobile devices has opened an array of possibilities for stroke survivors to remotely access specialized rehabilitation from their homes and communities (i.e., telerehabilitation). Telerehabilitation interventions have been used effectively for check-in sessions, education, and counselling after stroke, but knowledge of the effectiveness of using telerehabilitation for the delivery of exercise interventions for lower extremity recovery is limited.
The investigators developed the TeleRehabilitation with Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL) to address the unmet needs for lower extremity rehabilitation after stroke, and the need for accessible rehabilitation in the face of the COVID-19 pandemic. TRAIL is an exercise program designed to promote lower extremity recovery using technology with real-time therapist instruction and guidance. The investigators recently conducted a proof-of-concept, single-group feasibility study of TRAIL (TRAIL-PROOF). From TRAIL-PROOF, there were have no reports of serious adverse events and 100% retention of participants. Preliminary analysis of 32 individuals completed also suggest improvements in the clinical outcomes, including increased lower extremity strength, functional balance, and balance self-efficacy. Thus, from TRAIL-PROOF, it is evident that the TRAIL protocol has potential to improve lower extremity function among community-dwelling adults with stroke experiencing lower extremity impairment. The investigators now propose a full-scaled randomized controlled trial to further study the TRAIL program (TRAIL-RCT).
The objectives for TRAIL-RCT are as follows:
1. The primary objective is to compare functional mobility (Timed Up and Go, primary clinical outcome) after 4 weeks of TRAIL to a 4-week attention-controlled education program (EDUCATION) in individuals ≤12 months post-stroke;
2. The secondary objective is to compare the 4-week TRAIL and EDUCATION programs on secondary outcomes of:
1. Lower extremity strength (30-Second Sit-to Stand test);
2. Functional balance (Tandem Stand and Functional Reach);
3. Motor impairment (Virtual Fugl-Meyer Assessment);
4. Balance self-efficacy (Activities-specific Balance Confidence Scale);
3. The tertiary objective is to compare the 4-week TRAIL and EDUCATION programs on health economic outcomes:
1. Health-related quality of life (Stroke Impact Scale, EuroQol-5D-5 Level); and
2. Health resources and costs (Health Resource Utilization Questionnaire)
4. The quaternary objective is to evaluate the feasibility of a subsequent larger multisite implementation stepped wedge randomized trial of TRAIL using pre-specified criteria related to process, resources, management, and scientific indicators.
It is hypothesized that:
The primary hypothesis is that the 4-week TRAIL program will lead to greater improvement in functional mobility, as measured by the Timed Up and Go, compared to the 4-week EDUCATION program in individuals ≤12 months post-stroke (Objective 1, primary clinical outcome).
The investigators also anticipate that greater improvements will be observed in the secondary clinical outcomes, in the areas of lower extremity muscle strength, motor impairment, functional balance, and balance self-efficacy, following TRAIL compared to EDUCATION (Objective 2).
The tertiary hypothesis is that the TRAIL intervention will demonstrate superior health economic outcomes compared to the EDUCATION group (Objective 3).
The quaternary hypothesis is that the protocol will demonstrate sufficient feasibility (e.g., rates of recruitment/retention, treatment fidelity and adherence, safety, treatment effects) to support a subsequent larger multi-site implementation stepped wedge randomized controlled trial (Objective 4).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TRAIL
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).
TRAIL
Each week has a specific focus for lower extremity rehabilitation:
Week 1) Building a base: 8 exercises, 10-15 repetitions x 2-3 sets
Week 2) Increasing repetitions: 8 exercises, 15-20 repetitions x 3 sets
Week 3) Building exercise tolerance:10 exercises, 15-20 repetitions x 3 sets
Week 4) Maximizing repetitions: 10 exercises, 30 seconds as many reps as possible x 2 sets
At the end of the second exercise session each week, the therapist and participants work collaboratively to develop an independent exercise action plan to be completed before the first session of the next week. The self-managed plans includes exercises selected from TRAIL, agreed upon by the participant and therapist, that are safe to perform without therapist oversight. The aims of the exercise action plan are to: i) Add exercise volume without using program resources (e.g., therapist time); and ii) Build capacity for self-management for long-term health and well-being after TRAIL has ended.
EDUCATION
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).
EDUCATION
EDUCATION has a specific focus on:
Week 1) What is stroke (e.g., gaining an understanding of the function of the brain, types of stroke and how stroke affects physical function) and introduction to self-management;
Week 2) What is self-management;
Week 3) Self-management for post-stroke complications (e.g., activities of daily living);
Week 4) Self-management for secondary prevention (e.g., blood pressure, diet, medication, stress management).
Education therapists will be provided with lesson plans and manuals to be circulated with the participants, and will facilitate the educational session through interactive Powerpoint presentations. In addition, participants will be asked to complete 30-60 minutes of educational homework, which will be discussed at the commencement of the following session.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TRAIL
Each week has a specific focus for lower extremity rehabilitation:
Week 1) Building a base: 8 exercises, 10-15 repetitions x 2-3 sets
Week 2) Increasing repetitions: 8 exercises, 15-20 repetitions x 3 sets
Week 3) Building exercise tolerance:10 exercises, 15-20 repetitions x 3 sets
Week 4) Maximizing repetitions: 10 exercises, 30 seconds as many reps as possible x 2 sets
At the end of the second exercise session each week, the therapist and participants work collaboratively to develop an independent exercise action plan to be completed before the first session of the next week. The self-managed plans includes exercises selected from TRAIL, agreed upon by the participant and therapist, that are safe to perform without therapist oversight. The aims of the exercise action plan are to: i) Add exercise volume without using program resources (e.g., therapist time); and ii) Build capacity for self-management for long-term health and well-being after TRAIL has ended.
EDUCATION
EDUCATION has a specific focus on:
Week 1) What is stroke (e.g., gaining an understanding of the function of the brain, types of stroke and how stroke affects physical function) and introduction to self-management;
Week 2) What is self-management;
Week 3) Self-management for post-stroke complications (e.g., activities of daily living);
Week 4) Self-management for secondary prevention (e.g., blood pressure, diet, medication, stress management).
Education therapists will be provided with lesson plans and manuals to be circulated with the participants, and will facilitate the educational session through interactive Powerpoint presentations. In addition, participants will be asked to complete 30-60 minutes of educational homework, which will be discussed at the commencement of the following session.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
McMaster University
OTHER
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Brodie Sakakibara
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brodie Sakakibara, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Ada Tang, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of British Columbia
Vancouver, British Columbia, Canada
Dalhousie University
Nova Scotia, Halifax, Canada
Riverview Health Centre
Winnipeg, Manitoba, Canada
Parkwood Institute
London, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Sakakibara BM, Wiley E, Barclay R, Bayley M, Davis JC, Eng JJ, Harris A, Inness EL, MacKay-Lyons M, Monaghan J, Pollock C, Pooyania S, Schneeberg A, Teasell R, Yao J, Tang A. TeleRehabilitation with Aims to Improve Lower extremity recovery in community-dwelling individuals who have had a stroke: protocol for a multisite, parallel group, assessor-blinded, randomised attention-controlled trial. BMJ Open. 2023 Jul 19;13(7):e076723. doi: 10.1136/bmjopen-2023-076723.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TRAIL-RCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.