Stroke Clinical Trial
— TRAIL-RCTOfficial title:
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - =19 years of age, =12 months post-stroke with lower extremity hemiparesis - 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: - Currently participating in formal in- or out-patient stroke rehabilitation focusing on lower extremity training - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Parkwood Institute | London | Ontario |
Canada | Dalhousie University | Nova Scotia | Halifax |
Canada | University Health Network | Toronto | Ontario |
Canada | University of British Columbia | Vancouver | British Columbia |
Canada | Riverview Health Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | McMaster University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Feasibility Indicator: Recruitment Rate | Number of participants recruited | Study Completion (Post-Intervention, immediately following study completion) | |
Other | Feasibility Indicator: Retention Rate | Number of participants with post-intervention data | Study Completion (Post-Intervention, immediately following study completion) | |
Other | Feasibility Indicator: Perceived Benefit of Telerehabilitation | Satisfaction survey administered at the end of post-intervention visit | Post-Intervention (immediately following 4 weeks of intervention) | |
Other | Feasibility Indicator: Treatment Fidelity | Percentage of telerehabilitation sessions attended, exercise completed during telerehabilitation sessions, and self-management sessions completed | Post-Intervention (immediately following 4 weeks of intervention) | |
Other | Feasibility Indicator: Blinding of Outcome Assessors | Percentage of outcome assessors remaining blinded to group allocation throughout duration of study | Study Completion (Post-Intervention, immediately following study completion) | |
Other | Feasibility Indicator: Appropriateness of Randomization Process | Number of participants per group and baseline differences in outcomes between groups
Baseline differences between groups |
Study Completion (Post-Intervention, immediately following study completion) | |
Other | 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) | Study Completion (Post-Intervention, immediately following study completion) | |
Other | Feasibility Indicator: Participant and Assessor Burden | Duration (measured in minutes) to complete the assessments. | Study Completion (Post-Intervention, immediately following study completion) | |
Other | Feasibility Indicator: Participant Burden | Percentages of participants with pre- and post-assessments | Study Completion (Post-Intervention, immediately following study completion) | |
Other | Feasibility Indicator: Ease of Using Equipment | Downtime due to technical issues of tablet and video-conferencing platform (measured in minutes) | Study Completion (Post-Intervention, immediately following study completion) | |
Other | Feasibility Indicator: Safety | Number of adverse events from the program sessions or assessments | Study Completion (Post-Intervention, immediately following study completion) | |
Other | Feasibility Indicator: Processing Time | Time from initial contact to enrolment | Study Completion (Post-Intervention, immediately following study completion) | |
Other | 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. | Baseline Assessment | |
Primary | Change from baseline Timed Up and Go (TUG) at 4 weeks | Performance walking test to assess functional mobility | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months | |
Secondary | 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. | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months | |
Secondary | 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 | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months | |
Secondary | Functional Reach | Performance measure to assess balance through maximal forward reach (in cm) from a fixed base | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months | |
Secondary | Modified Virtual Fugl-Meyer Assessment | Performance measure to assess lower extremity impairment | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months | |
Secondary | 30 second Sit to Stand | Performance measure used to assess lower extremity strength | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months | |
Secondary | Health Resource Utilization Questionnaire | Health care utilization calculated by assessing health professional visits, admissions to hospital, laboratory tests/ investigations, and use of medications | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months | |
Secondary | 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 | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months | |
Secondary | Tandem Stand | Performance measure to assess balance through holding a tandem stance position (up to 10 seconds; alternate positions: semi-tandem or feet together | Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months |
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