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

Stroke Clinical Trial

— TRAIL-RCT  

Official title:

Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908241
• Other study ID #: TRAIL-RCT
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2023
• Source: University of British Columbia
• Contact: Elise A Wiley, MSc
• Phone: (289) 214-1569
• Email: wileye[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Infarction
• Brain Ischemia
• Cardiovascular Diseases
• Central Nervous System Diseases
• Cerebral Infarction
• Cerebral Injury
• Cerebral Vascular Accident
• Cerebral Vascular Disorder
• Cerebrovascular Disorders
• Hemorrhagic Stroke
• Infarction
• Ischemic Stroke
• Nervous System Diseases
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic
• Vascular Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Parkwood Institute	London	Ontario
Canada	Dalhousie University	Nova Scotia	Halifax
Canada	University Health Network	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Canada	Riverview Health Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility Indicator: Recruitment Rate	Number of participants recruited	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Retention Rate	Number of participants with post-intervention data	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Perceived Benefit of Telerehabilitation	Satisfaction survey administered at the end of post-intervention visit	Post-Intervention (immediately following 4 weeks of intervention)
Other	Feasibility Indicator: Treatment Fidelity	Percentage of telerehabilitation sessions attended, exercise completed during telerehabilitation sessions, and self-management sessions completed	Post-Intervention (immediately following 4 weeks of intervention)
Other	Feasibility Indicator: Blinding of Outcome Assessors	Percentage of outcome assessors remaining blinded to group allocation throughout duration of study	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Appropriateness of Randomization Process	Number of participants per group and baseline differences in outcomes between groups; Baseline differences between groups	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Number of Participants Excluded based on Eligibility Criteria	Number of individuals excluded from potential participant list (referrals from inpatient stroke rehabilitation and community outreach)	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Participant and Assessor Burden	Duration (measured in minutes) to complete the assessments.	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Participant Burden	Percentages of participants with pre- and post-assessments	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Ease of Using Equipment	Downtime due to technical issues of tablet and video-conferencing platform (measured in minutes)	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Safety	Number of adverse events from the program sessions or assessments	Study Completion (Post-Intervention, immediately following study completion)
Other	Feasibility Indicator: Processing Time	Time from initial contact to enrolment	Study Completion (Post-Intervention, immediately following study completion)
Other	GENESIS-PRAXY Questionnaire	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.	Baseline Assessment
Primary	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	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.	Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary	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	Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary	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), 3-months, 6-months
Secondary	Modified Virtual Fugl-Meyer Assessment	Performance measure to assess lower extremity impairment	Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary	30 second Sit to Stand	Performance measure used to assess lower extremity strength	Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary	Health Resource Utilization Questionnaire	Health care utilization calculated by assessing health professional visits, admissions to hospital, laboratory tests/ investigations, and use of medications	Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary	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	Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary	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), 3-months, 6-months