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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | Receives the telerehabilitation protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Post-Intervention (immediately following 4 weeks of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Indicator: Recruitment Rate | Number of participants recruited. | Post-Intervention (immediately following 4 weeks of intervention) |
| Feasibility Indicator: Retention Rate | Percentage of participants with post-intervention data. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ada Tang, PhD | McMaster University | Principal Investigator |
| Brodie Sakakibara, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | V6T 1Z4 | Canada | ||
| Riverview Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38051660 | Derived | Park S, Tang A, Barclay R, Bayley M, Eng JJ, Mackay-Lyons M, Pollock C, Pooyania S, Teasell R, Yao J, Sakakibara BM. Investigating the Telerehabilitation With Aims to Improve Lower Extremity Recovery Poststroke Program: A Feasibility Study. Phys Ther. 2024 Mar 1;104(3):pzad165. doi: 10.1093/ptj/pzad165. |
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Single-group, pre-post study design
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| 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. | 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). | 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. | Baseline, Post-Intervention (immediately following 4 weeks of intervention) |
| modified virtual Fugl-Meyer Assessment | Performance measure to assess lower extremity impairment. | Baseline, Post-Intervention (immediately following 4 weeks of intervention) |
| 30 second Sit to Stand | Performance measure used to assess lower extremity strength. | 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. | Baseline, Post-Intervention (immediately following 4 weeks of intervention) |
| 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. | 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. | Post-Intervention (immediately following 4 weeks of intervention) |
| Feasibility Indicator: Participant Burden | Percentage of participants with pre- and post-assessments. | Post-Intervention (immediately following 4 weeks of intervention) |
| Feasibility Indicator: Participant Burden 2 | Duration to complete the assessments. | Post-Intervention (immediately following 4 weeks of intervention) |
| Feasibility Indicator: Assessor Burden | Duration to complete the assessments. | Post-Intervention (immediately following 4 weeks of intervention) |
| Feasibility Indicator: Therapist Burden | Time spent administering the telerehabilitation session. | 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. | Post-Intervention (immediately following 4 weeks of intervention) |
| Feasibility Indicator: Processing Time | Time from initial contact to enrolment. | 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. | Post-Intervention (immediately following 4 weeks of intervention) |
| Feasibility Indicator: Treatment Response | Paired sample t-test. | Post-Intervention (immediately following 4 weeks of intervention) |
| Feasibility Indicator: Treatment Effect | Estimate of effect size and variance for future sample size calculations. | Post-Intervention (immediately following 4 weeks of intervention) |
| Winnipeg |
| Manitoba |
| R3L 2P4 |
| Canada |
| Dalhousie University | Halifax | Nova Scotia | B3H 4R2 | Canada |
| Parkwood Institute | London | Ontario | N6C 5J1 | Canada |
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D002544 | Cerebral Infarction |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D002545 | Brain Ischemia |
| D020520 | Brain Infarction |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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