Recruiting

Telerehabilitation

Sponsor:

University of British Columbia

Code:

NCT04908241

Conditions

Stroke

Stroke, Ischemic

Stroke Hemorrhagic

Cerebral Injury

Cerebral Infarction

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

TRAIL

EDUCATION

Study Details

Brief summary:

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.

Conditions

Stroke

Stroke, Ischemic

Stroke Hemorrhagic

Cerebral Injury

Cerebral Infarction

Study ID

NCT04908241

Start date

Nov 8, 2021

Status verified date

Jun, 2023

Completion date

Aug 1, 2024

Anticipated

Primary completion date

Aug 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

active comparator: 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).

Interventions

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.

Primary outcome measure

  • Change from baseline Timed Up and Go (TUG) at 4 weeks [ Time Frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months ]

Central Contacts and Locations

Central contacts

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z4

Contacts

Principal Investigator:

Brodie Sakakibara, PhD

Dalhousie University

Recruiting

Nova Scotia, Halifax, Canada, B3H 4R2

Contacts

Principal Investigator:

Marilyn MacKay-Lyons, MScPT PhD

Riverview Health Centre

Recruiting

Winnipeg, Manitoba, Canada, R3L 2P4

Contacts

Principal Investigator:

Ruth Barclay, PhD

Parkwood Institute

Recruiting

London, Ontario, Canada, N6C 5J1

Contacts

Principal Investigator:

Robert Teasell, MD FRCP (C)

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Principal Investigator:

Mark Bayley, MD FRCPC

More Information

Sponsor

University of British Columbia

Last update posted

Jun 22, 2023

Last verified

Jun, 2023

Keywords

  • Telerehabilitation
  • Lower Extremity
  • Self-Management
  • Education
  • Secondary Prevention
  • Stroke
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-06-22.