An interventional study of TRAIL and EDUCATION in Stroke, Stroke, Ischemic and Stroke Hemorrhagic, sponsored by University of British Columbia. Recruiting at 5 sites in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the effectiveness of a 4-week lower extremity telerehabilitation protocol with aims to improve lower extremity function to a 4-week attention-controlled education program on lower extremity clinical outcomes, quality of life, and healthcare resources utilization among community dwelling adults with stroke across Canada.
With an aging population, and survival rates now at 83% in Canada, the number of stroke survivors is expected to reach 720,000 by 2038. While 90% of individuals with stroke return to independent community living, 80% report residual motor impairment, such as loss or limitation in motor control, or mobility limitation. These limitations have profound effects on the ability to perform everyday activities and are associated with substantial economic strain on the healthcare system. Thus, a primary focus of stroke rehabilitation is on the recovery of motor function, walking and balance, using exercise via physical therapy.
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:
The secondary objective is to compare the 4-week TRAIL and EDUCATION programs on secondary outcomes of:
The tertiary objective is to compare the 4-week TRAIL and EDUCATION programs on health economic outcomes:
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).
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 96 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
Other: TRAIL
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).
Other: EDUCATION
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 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.
Change from baseline Timed Up and Go (TUG) at 4 weeks
Performance walking test to assess functional mobility
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Stroke Impact Scale (SIS)
Stroke specific, self-reported health status measure. There are 8 domains assessed in this version and each item is rated using a 5-point Likert scale. The participant rates his/her difficulty completing the task from 1 to 5, where lower scores mean greater difficulty to complete the item.
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Activities-Specific Balance (ABC) Scale
Self-reported questionnaire measuring self-efficacy in performing activities without losing balance. The ABC Scale consists of 16 questions that require the participant to rate their confidence in performing the activity from 0% to 100%, where higher percentages indicate greater self-efficacy
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Functional Reach
Performance measure to assess balance through maximal forward reach (in cm) from a fixed base
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Modified Virtual Fugl-Meyer Assessment
Performance measure to assess lower extremity impairment
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
30 second Sit to Stand
Performance measure used to assess lower extremity strength
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Health Resource Utilization Questionnaire
Health care utilization calculated by assessing health professional visits, admissions to hospital, laboratory tests/ investigations, and use of medications
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Health-related quality of life (EuroQol-5D-5 Level)
A generic preference-based utility instrument composed of 5 domains of health (mobility, self-care, usual activities, pain, anxiety/depression), each with 5 levels (1=no problems, 5=major problems), which is often used to calculate cost-utility
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Tandem Stand
Performance measure to assess balance through holding a tandem stance position (up to 10 seconds; alternate positions: semi-tandem or feet together
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Feasibility Indicator: Recruitment Rate
Number of participants recruited
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Retention Rate
Number of participants with post-intervention data
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Perceived Benefit of Telerehabilitation
Satisfaction survey administered at the end of post-intervention visit
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Treatment Fidelity
Percentage of telerehabilitation sessions attended, exercise completed during telerehabilitation sessions, and self-management sessions completed
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Blinding of Outcome Assessors
Percentage of outcome assessors remaining blinded to group allocation throughout duration of study
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Appropriateness of Randomization Process
Number of participants per group and baseline differences in outcomes between groups Baseline differences between groups
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Number of Participants Excluded based on Eligibility Criteria
Number of individuals excluded from potential participant list (referrals from inpatient stroke rehabilitation and community outreach)
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Participant and Assessor Burden
Duration (measured in minutes) to complete the assessments.
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Participant Burden
Percentages of participants with pre- and post-assessments
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Ease of Using Equipment
Downtime due to technical issues of tablet and video-conferencing platform (measured in minutes)
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Safety
Number of adverse events from the program sessions or assessments
Time frame: Study Completion (Post-Intervention, immediately following study completion)
Feasibility Indicator: Processing Time
Time from initial contact to enrolment
Time frame: Study Completion (Post-Intervention, immediately following study completion)
GENESIS-PRAXY Questionnaire
Questionnaire used to assess gender-related measures encompassing gender roles, relations and identity. A composite score is calculated to determine whether an individual has primarily masculine, neutral or feminine gender characteristics.
Time frame: Baseline Assessment
Plan to share: Yes — The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form will be shared with qualified researchers engaging in independent scientific research, upon request to the research team.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: After the study end.
Access criteria: Please contact the research team.
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Aug 2024, 32 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 32 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
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