Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT)

NCT04908241 | Unknown

• 1 other identifier: TRAIL-RCT
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

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; Brain Diseases; Central Nervous System Diseases; Cerebral Vascular Accident; Cerebral Vascular Disorder; Brain Ischemia; Brain Infarction; Cardiovascular Diseases; Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Stroke Impact Scale (SIS)

  Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months

• Activities-Specific Balance (ABC) Scale

  Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months

• Functional Reach

  Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months

• Modified Virtual Fugl-Meyer Assessment

  Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months

• 30 second Sit to Stand

  Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months

Other Outcomes (13)

• Feasibility Indicator: Recruitment Rate

  Study Completion (Post-Intervention, immediately following study completion)

• Feasibility Indicator: Retention Rate

  Study Completion (Post-Intervention, immediately following study completion)

• Feasibility Indicator: Perceived Benefit of Telerehabilitation

  Post-Intervention (immediately following 4 weeks of intervention)

Study Arms (2)

TRAIL

EXPERIMENTAL

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

EDUCATION

ACTIVE COMPARATOR

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

Interventions

TRAIL OTHER

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.

TRAIL

EDUCATION OTHER

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.

EDUCATION

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• McMaster University: collaborator

Study Sites (5)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

RECRUITING

Dalhousie University

Nova Scotia, Halifax, B3H 4R2, Canada

RECRUITING

Riverview Health Centre

Winnipeg, Manitoba, R3L 2P4, Canada

RECRUITING

Parkwood Institute

London, Ontario, N6C 5J1, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (1)

• Sakakibara BM, Wiley E, Barclay R, Bayley M, Davis JC, Eng JJ, Harris A, Inness EL, MacKay-Lyons M, Monaghan J, Pollock C, Pooyania S, Schneeberg A, Teasell R, Yao J, Tang A. TeleRehabilitation with Aims to Improve Lower extremity recovery in community-dwelling individuals who have had a stroke: protocol for a multisite, parallel group, assessor-blinded, randomised attention-controlled trial. BMJ Open. 2023 Jul 19;13(7):e076723. doi: 10.1136/bmjopen-2023-076723.

  PMID: 37474180 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Brain Injuries; Cerebral Infarction; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Brain Ischemia; Brain Infarction; Cardiovascular Diseases; Infarction; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Nervous System Diseases; Vascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Brodie Sakakibara, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Ada Tang, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise A Wiley, MSc

CONTACT

(289) 214-1569; wileye@mcmaster.ca

Brodie Sakakibara, PhD

CONTACT

(250) 807-8505; brodie@mail.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participants' group allocation, whereby they will not be involved with delivering the TRAIL or EDUCATION programs. Participants are informed of their group assignment, however they will not know if they are in the experimental or control program, and instructed to withhold it from the assessors to ensure proper blinding and minimize internal bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Following baseline assessment, participants will be randomized into the TRAIL or EDUCATION arm. Following randomization, participants will remain in their allocated group until the completion of the study. A central research coordinator that is not involved in recruitment, assessments or study intervention, will be responsible for randomization of study participants, and will advise the participant and site coordinator of the group allocation. There will be four timepoints where outcome assessments will be conducted, which include baseline (T0), 1-month (T1), 3-months (T2), and 6-months (T3) follow-up.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 1, 2021
• Study Start: November 8, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study end.
• Access Criteria: Please contact the research team.

Locations

CA (5)