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

Primary Purpose

Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TRAIL
EDUCATION
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Telerehabilitation, Lower Extremity, Self-Management, Education, Secondary Prevention, Stroke, Exercise

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • โ‰ฅ19 years of age, โ‰ค12 months post-stroke with lower extremity hemiparesis
  • Able to walk โ‰ฅ10 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

Sites / Locations

  • University of British ColumbiaRecruiting
  • Dalhousie UniversityRecruiting
  • Riverview Health CentreRecruiting
  • Parkwood InstituteRecruiting
  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRAIL

EDUCATION

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change from baseline Timed Up and Go (TUG) at 4 weeks
Performance walking test to assess functional mobility

Secondary Outcome Measures

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.
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
Functional Reach
Performance measure to assess balance through maximal forward reach (in cm) from a fixed base
Modified Virtual Fugl-Meyer Assessment
Performance measure to assess lower extremity impairment
30 second Sit to Stand
Performance measure used to assess lower extremity strength
Health Resource Utilization Questionnaire
Health care utilization calculated by assessing health professional visits, admissions to hospital, laboratory tests/ investigations, and use of medications
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
Tandem Stand
Performance measure to assess balance through holding a tandem stance position (up to 10 seconds; alternate positions: semi-tandem or feet together

Full Information

First Posted
May 20, 2021
Last Updated
June 19, 2023
Sponsor
University of British Columbia
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04908241
Brief Title
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT)
Acronym
TRAIL-RCT
Official Title
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
With an aging population, and survival rates now at 83% in Canada, the number of stroke survivors is expected to reach 720,000 by 2038. While 90% of individuals with stroke return to independent community living, 80% report residual motor impairment, such as loss or limitation in motor control, or mobility limitation. These limitations have profound effects on the ability to perform everyday activities and are associated with substantial economic strain on the healthcare system. Thus, a primary focus of stroke rehabilitation is on the recovery of motor function, walking and balance, using exercise via physical therapy. The rapid growth in Internet use and personal mobile devices has opened an array of possibilities for stroke survivors to remotely access specialized rehabilitation from their homes and communities (i.e., telerehabilitation). Telerehabilitation interventions have been used effectively for check-in sessions, education, and counselling after stroke, but knowledge of the effectiveness of using telerehabilitation for the delivery of exercise interventions for lower extremity recovery is limited. The investigators developed the TeleRehabilitation with Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL) to address the unmet needs for lower extremity rehabilitation after stroke, and the need for accessible rehabilitation in the face of the COVID-19 pandemic. TRAIL is an exercise program designed to promote lower extremity recovery using technology with real-time therapist instruction and guidance. The investigators recently conducted a proof-of-concept, single-group feasibility study of TRAIL (TRAIL-PROOF). From TRAIL-PROOF, there were have no reports of serious adverse events and 100% retention of participants. Preliminary analysis of 32 individuals completed also suggest improvements in the clinical outcomes, including increased lower extremity strength, functional balance, and balance self-efficacy. Thus, from TRAIL-PROOF, it is evident that the TRAIL protocol has potential to improve lower extremity function among community-dwelling adults with stroke experiencing lower extremity impairment. The investigators now propose a full-scaled randomized controlled trial to further study the TRAIL program (TRAIL-RCT). The objectives for TRAIL-RCT are as follows: The primary objective is to compare functional mobility (Timed Up and Go, primary clinical outcome) after 4 weeks of TRAIL to a 4-week attention-controlled education program (EDUCATION) in individuals โ‰ค12 months post-stroke; The secondary objective is to compare the 4-week TRAIL and EDUCATION programs on secondary outcomes of: Lower extremity strength (30-Second Sit-to Stand test); Functional balance (Tandem Stand and Functional Reach); Motor impairment (Virtual Fugl-Meyer Assessment); Balance self-efficacy (Activities-specific Balance Confidence Scale); The tertiary objective is to compare the 4-week TRAIL and EDUCATION programs on health economic outcomes: Health-related quality of life (Stroke Impact Scale, EuroQol-5D-5 Level); and Health resources and costs (Health Resource Utilization Questionnaire) The quaternary objective is to evaluate the feasibility of a subsequent larger multisite implementation stepped wedge randomized trial of TRAIL using pre-specified criteria related to process, resources, management, and scientific indicators. It is hypothesized that: The primary hypothesis is that the 4-week TRAIL program will lead to greater improvement in functional mobility, as measured by the Timed Up and Go, compared to the 4-week EDUCATION program in individuals โ‰ค12 months post-stroke (Objective 1, primary clinical outcome). The investigators also anticipate that greater improvements will be observed in the secondary clinical outcomes, in the areas of lower extremity muscle strength, motor impairment, functional balance, and balance self-efficacy, following TRAIL compared to EDUCATION (Objective 2). The tertiary hypothesis is that the TRAIL intervention will demonstrate superior health economic outcomes compared to the EDUCATION group (Objective 3). The quaternary hypothesis is that the protocol will demonstrate sufficient feasibility (e.g., rates of recruitment/retention, treatment fidelity and adherence, safety, treatment effects) to support a subsequent larger multi-site implementation stepped wedge randomized controlled trial (Objective 4).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRAIL
Arm Type
Experimental
Arm Description
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).
Arm Title
EDUCATION
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
TRAIL
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EDUCATION
Intervention Description
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 Information:
Title
Change from baseline Timed Up and Go (TUG) at 4 weeks
Description
Performance walking test to assess functional mobility
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary Outcome Measure Information:
Title
Stroke Impact Scale (SIS)
Description
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.
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Title
Activities-Specific Balance (ABC) Scale
Description
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
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Title
Functional Reach
Description
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), 3-months, 6-months
Title
Modified Virtual Fugl-Meyer Assessment
Description
Performance measure to assess lower extremity impairment
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Title
30 second Sit to Stand
Description
Performance measure used to assess lower extremity strength
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Title
Health Resource Utilization Questionnaire
Description
Health care utilization calculated by assessing health professional visits, admissions to hospital, laboratory tests/ investigations, and use of medications
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Title
Health-related quality of life (EuroQol-5D-5 Level)
Description
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
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Title
Tandem Stand
Description
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), 3-months, 6-months
Other Pre-specified Outcome Measures:
Title
Feasibility Indicator: Recruitment Rate
Description
Number of participants recruited
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Retention Rate
Description
Number of participants with post-intervention data
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Perceived Benefit of Telerehabilitation
Description
Satisfaction survey administered at the end of post-intervention visit
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Treatment Fidelity
Description
Percentage of telerehabilitation sessions attended, exercise completed during telerehabilitation sessions, and self-management sessions completed
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Blinding of Outcome Assessors
Description
Percentage of outcome assessors remaining blinded to group allocation throughout duration of study
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Appropriateness of Randomization Process
Description
Number of participants per group and baseline differences in outcomes between groups Baseline differences between groups
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Number of Participants Excluded based on Eligibility Criteria
Description
Number of individuals excluded from potential participant list (referrals from inpatient stroke rehabilitation and community outreach)
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Participant and Assessor Burden
Description
Duration (measured in minutes) to complete the assessments.
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Participant Burden
Description
Percentages of participants with pre- and post-assessments
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Ease of Using Equipment
Description
Downtime due to technical issues of tablet and video-conferencing platform (measured in minutes)
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Safety
Description
Number of adverse events from the program sessions or assessments
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
Feasibility Indicator: Processing Time
Description
Time from initial contact to enrolment
Time Frame
Study Completion (Post-Intervention, immediately following study completion)
Title
GENESIS-PRAXY Questionnaire
Description
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.
Time Frame
Baseline Assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: โ‰ฅ19 years of age, โ‰ค12 months post-stroke with lower extremity hemiparesis Able to walk โ‰ฅ10 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise A Wiley, MSc
Phone
(289) 214-1569
Email
wileye@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Brodie Sakakibara, PhD
Phone
(250) 807-8505
Email
brodie@mail.ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brodie Sakakibara, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ada Tang, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise A Wiley, MSc
Phone
(289) 214-1569
Email
wileye@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Brodie Sakakibara, PhD
Phone
(250) 807-8505
Email
brodie@mail.ubc.ca
First Name & Middle Initial & Last Name & Degree
Brodie Sakakibara, PhD
First Name & Middle Initial & Last Name & Degree
Janice Eng, PT/OT PhD
First Name & Middle Initial & Last Name & Degree
Courtney Pollock, PT PhD
Facility Name
Dalhousie University
City
Nova Scotia
State/Province
Halifax
ZIP/Postal Code
B3H 4R2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Dunlop
Phone
905-473-1401
Email
melanie.dunlop@nshealth.ca
First Name & Middle Initial & Last Name & Degree
Judy Lugar
Phone
902-225-6003
Email
judy@lugar.ca
First Name & Middle Initial & Last Name & Degree
Marilyn MacKay-Lyons, MScPT PhD
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olayinka Akinrolie
Email
akinrolo@myumanitoba.ca
First Name & Middle Initial & Last Name & Degree
Anuprita Kanitkar
Phone
204-881-3112
Email
Anuprita.Kanitkar@umanitoba.ca
First Name & Middle Initial & Last Name & Degree
Ruth Barclay, PhD
First Name & Middle Initial & Last Name & Degree
Sepideh Pooyania, MD FRCPC
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandria Roa Agudelo
Phone
(519) 646-6100
Ext
42570
Email
alexandria.roaagudelo@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Arden Lawson, BMSc
Phone
(519) 646-6100
Ext
42570
Email
arden.lawson@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Robert Teasell, MD FRCP (C)
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Yaroslavtseva
Phone
416-876-4823
Email
olga.yaroslavtseva@uhn.ca
First Name & Middle Initial & Last Name & Degree
Mark Bayley, MD FRCPC

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form will be shared with qualified researchers engaging in independent scientific research, upon request to the research team.
IPD Sharing Time Frame
After the study end.
IPD Sharing Access Criteria
Please contact the research team.

Learn more about this trial

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

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