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

University of British Columbia

Status: Enrolling

Conditions: Brain Ischemia; Stroke; Brain Infarction; Central Nervous System Diseases; Stroke Hemorrhagic; Cardiovascular Diseases; Stroke, Ischemic; Cerebral Injury; Infarction; Cerebral Vascular Accident; Cerebral Infarction; Cerebral Vascular Disorder; Brain Diseases

Treatments: Other: TRAIL; Other: EDUCATION

Study type: Interventional

Funder types: Other

Identifiers

NCT04908241

TRAIL-RCT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 96 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

TRAIL

Experimental group

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).

Treatment:

Other: TRAIL

EDUCATION

Active Comparator group

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).

Treatment:

Other: EDUCATION