An interventional study of Telerehabilitation in Stroke, Stroke, Ischemic and Stroke Hemorrhagic, sponsored by University of British Columbia. Completed at 5 sites in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
The purpose of this study is to examine the feasibility and effectiveness of a lower extremity telerehabilitation protocol with aims to improve lower extremity recovery among community-living stroke survivors across Canada.
Eighty percent of stroke survivors experience some form of motor impairment, such as loss or limitation of function in muscle control or movement, or mobility limitation. Regaining walking ability is a priority for most and is achieved in approximately 80%. Unfortunately, the occurrence of falling while walking is as high as 73% of all people who recover the ability to walk post-stroke, with falls often occurring within the first few months of returning home from rehabilitation. This highlights the challenges with transitioning to the community for continued post-stroke rehabilitation. Unfortunately, due to increasing demand on our healthcare and rehabilitation systems and limited service capacity, stroke survivors receive minimal to no follow-up rehabilitation after returning to community-living. As a result, it is common for stroke survivors to report unmet lower extremity rehabilitation needs, and thus ongoing walking/mobility impairment, balance issues, high incidence of falls, and difficulties participating in desired social roles.
The rapid growth in the use of the Internet and personal mobile technologies, including computers, smartphones, and tablets has opened up an array of possibilities through which patients can remotely access specialized health services, such as telerehabilitation supports, while in their homes and communities. The use of technologies to facilitate optimal rehabilitation and recovery after stroke is under-utilized in Canada, despite being highly recommended in Canadian stroke guidelines, and positive beliefs about its potential among people with stroke.
Objectives:
Hypotheses:
The investigators expect that the the telerehabilitation protocol will demonstrate sufficient feasibility to support a larger, multisite randomized controlled trial (RCT). The investigators also hypothesize that stroke survivors will improve in functional mobility, lower extremity strength and motor impairment, functional balance, quality of life, balance self-efficacy, and goal attainment following 4-weeks of telerehabilitation with a trained therapist
This feasibility study will use a single group, pre- post- study design trial.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 32 is below 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives the telerehabilitation protocol
Behavioral: Telerehabilitation
Participants in the telerehabilitation program will receive a graded exercise and self-management intervention. This program will be delivered in a ≤2:1 participant:therapist ratio. Each participant grouping will receive two 60-90 minutes telerehabilitation sessions per week for 4 weeks focusing on lower extremity recovery (total 8-12 hours), with a therapist trained in the use of technology for the provision of rehabilitation. Participants will also be asked to complete at least one additional independent self-managed exercise session each week. This independent exercise session will include selected exercises from the telerehabilitation sessions that will be safe to perform without therapist oversight, and jointly agreed upon by the participant and therapist.
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)
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 patient rates his/her difficulty completing each item from 1 to 5, and lower scores mean greater difficulty to complete the item.
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
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 patient to rate their confidence on a scale from 0% to 100%. The higher the percentage, the higher level of physical functioning.
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
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)
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)
modified virtual Fugl-Meyer Assessment
Performance measure to assess lower extremity impairment.
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
30 second Sit to Stand
Performance measure used to assess lower extremity strength.
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Goal Attainment Scale
An individualized measure involving goal identification, prioritization, and scaling that is standardized to calculate the extent to which a participant's goals are met as a result of the intervention or therapy. Participants rate their goal attainment on a 5-point response scale, ranging from -2 (worse than expected outcome) to +2 (much better outcome), with higher scores indicating a higher degree of goal attainment.
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Recruitment Rate
Number of participants recruited.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Retention Rate
Percentage of participants with post-intervention data.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Perceived Benefit of Telerehabilitation
Satisfaction survey administered at the end of the 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, self-managed exercise plans completed.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Participant Burden
Percentage of participants with pre- and post-assessments.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Participant Burden 2
Duration to complete the assessments.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Assessor Burden
Duration to complete the assessments.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Therapist Burden
Time spent administering the telerehabilitation session.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Ease of Using Equipment
Downtime due to technical issues of tablet and video-conferencing platform.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Processing Time
Time from initial contact to enrolment.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Incidence of Treatment-Emergent Adverse Events (Safety)
Adverse events from the telerehabilitation sessions or assessments.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Treatment Response
Paired sample t-test.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Treatment Effect
Estimate of effect size and variance for future sample size calculations.
Time frame: Post-Intervention (immediately following 4 weeks of intervention)
Plan to share: No
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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