Clinical trial NCT04908241: Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT)
Official title: Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2021-06-01
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

1. 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 ≤12 months post-stroke;
2. The secondary objective is to compare the 4-week TRAIL and EDUCATION programs on secondary outcomes of:

   1. Lower extremity strength (30-Second Sit-to Stand test);
   2. Functional balance (Tandem Stand and Functional Reach);
   3. Motor impairment (Virtual Fugl-Meyer Assessment);
   4. Balance self-efficacy (Activities-specific Balance Confidence Scale);
3. The tertiary objective is to compare the 4-week TRAIL and EDUCATION programs on health economic outcomes:

   1. Health-related quality of life (Stroke Impact Scale, EuroQol-5D-5 Level); and
   2. Health resources and costs (Health Resource Utilization Questionnaire)
4. 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 ≤12 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Timed Up and Go (TUG) at 4 weeks
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary outcomes:
measure: Stroke Impact Scale (SIS)
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
measure: Activities-Specific Balance (ABC) Scale
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
measure: Functional Reach
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
measure: Modified Virtual Fugl-Meyer Assessment
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
measure: 30 second Sit to Stand
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
measure: Health Resource Utilization Questionnaire
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
measure: Health-related quality of life (EuroQol-5D-5 Level)
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
measure: Tandem Stand
timeFrame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Other outcomes:
measure: Feasibility Indicator: Recruitment Rate
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Retention Rate
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Perceived Benefit of Telerehabilitation
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Treatment Fidelity
timeFrame: Post-Intervention (immediately following 4 weeks of intervention)
measure: Feasibility Indicator: Blinding of Outcome Assessors
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Appropriateness of Randomization Process
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Number of Participants Excluded based on Eligibility Criteria
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Participant and Assessor Burden
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Participant Burden
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Ease of Using Equipment
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Safety
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: Feasibility Indicator: Processing Time
timeFrame: Study Completion (Post-Intervention, immediately following study completion)
measure: GENESIS-PRAXY Questionnaire
timeFrame: Baseline Assessment
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Nova Scotia
country: Canada
facility: Dalhousie University
state: Halifax
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Brodie Sakakibara, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Ada Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: