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

The purpose of this study is to examine the feasibility and effectiveness of a lower extremity telerehabilitation protocol with aims to improve lower extremity recovery among community-living stroke survivors across Canada.

Study Overview

• Status: Completed
• Conditions: Infarction; Cardiovascular Diseases; Stroke; Brain Diseases; Central Nervous System Diseases; Brain Ischemia; Cerebral Infarction; Brain Infarction; Stroke, Ischemic; Stroke Hemorrhagic; Cerebral Vascular Disorder
• Intervention / Treatment: Behavioral: Telerehabilitation

Detailed Description

Eighty percent of stroke survivors experience some form of motor impairment, such as loss or limitation of function in muscle control or movement, or mobility limitation. Regaining walking ability is a priority for most and is achieved in approximately 80%. Unfortunately, the occurrence of falling while walking is as high as 73% of all people who recover the ability to walk post-stroke, with falls often occurring within the first few months of returning home from rehabilitation. This highlights the challenges with transitioning to the community for continued post-stroke rehabilitation. Unfortunately, due to increasing demand on our healthcare and rehabilitation systems and limited service capacity, stroke survivors receive minimal to no follow-up rehabilitation after returning to community-living. As a result, it is common for stroke survivors to report unmet lower extremity rehabilitation needs, and thus ongoing walking/mobility impairment, balance issues, high incidence of falls, and difficulties participating in desired social roles.

The rapid growth in the use of the Internet and personal mobile technologies, including computers, smartphones, and tablets has opened up an array of possibilities through which patients can remotely access specialized health services, such as telerehabilitation supports, while in their homes and communities. The use of technologies to facilitate optimal rehabilitation and recovery after stroke is under-utilized in Canada, despite being highly recommended in Canadian stroke guidelines, and positive beliefs about its potential among people with stroke.

Objectives:

1. To examine the feasibility (e.g. safety, recruitment rate, retention rate, fidelity and adherence, burden) of a lower extremity telerehabilitation protocol among community-living stroke survivors
2. To estimate the size of effect of TRAIL on clinical outcomes of functional mobility, lower extremity strength and motor impairment, functional balance, quality of life, balance self-efficacy, and goal attainment among community-living stroke survivors

Hypotheses:

The investigators expect that the the telerehabilitation protocol will demonstrate sufficient feasibility to support a larger, multisite randomized controlled trial (RCT). The investigators also hypothesize that stroke survivors will improve in functional mobility, lower extremity strength and motor impairment, functional balance, quality of life, balance self-efficacy, and goal attainment following 4-weeks of telerehabilitation with a trained therapist

This feasibility study will use a single group, pre- post- study design trial.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • University of British Columbia
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3L 2P4
      • Riverview Health Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4R2
      • Dalhousie University
  • Ontario
    • London, Ontario, Canada, N6C 5J1
      • Parkwood Institute
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 19 year of age or older;
• Within 18 months of the most recent stroke;
• Hemiparesis of the lower extremity;
• Able to walk 10m without physical assistance;
• Able to tolerate 50 minutes of activity (including rest breaks, as needed);
• Have cognitive-communicative ability to participate as per clinical judgement
• Able to provide informed consent;

Exclusion Criteria:

• Currently receiving in- or outpatient rehabilitation;
• Living in long-term care;
• Severe vision or hearing loss;
• Other neurological conditions, e.g. Parkinson's disease;
• Presence of significant comorbidities (e.g. severe osteoarthritis), pain or other symptoms that significantly impact lower extremity function;
• Planned surgery that would preclude or affect participation in the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Telerehabilitation; Receives the telerehabilitation protocol

Behavioral: Telerehabilitation; Participants in the telerehabilitation program will receive a graded exercise and self-management intervention. This program will be delivered in a ≤2:1 participant:therapist ratio. Each participant grouping will receive two 60-90 minutes telerehabilitation sessions per week for 4 weeks focusing on lower extremity recovery (total 8-12 hours), with a therapist trained in the use of technology for the provision of rehabilitation. Participants will also be asked to complete at least one additional independent self-managed exercise session each week. This independent exercise session will include selected exercises from the telerehabilitation sessions that will be safe to perform without therapist oversight, and jointly agreed upon by the participant and therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 patient rates his/her difficulty completing each item from 1 to 5, and lower scores mean greater difficulty to complete the item.	Baseline, Post-Intervention (immediately following 4 weeks of intervention)
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 patient to rate their confidence on a scale from 0% to 100%. The higher the percentage, the higher level of physical functioning.	Baseline, Post-Intervention (immediately following 4 weeks of intervention)
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)
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)
modified virtual Fugl-Meyer Assessment	Performance measure to assess lower extremity impairment.	Baseline, Post-Intervention (immediately following 4 weeks of intervention)
30 second Sit to Stand	Performance measure used to assess lower extremity strength.	Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Goal Attainment Scale	An individualized measure involving goal identification, prioritization, and scaling that is standardized to calculate the extent to which a participant's goals are met as a result of the intervention or therapy. Participants rate their goal attainment on a 5-point response scale, ranging from -2 (worse than expected outcome) to +2 (much better outcome), with higher scores indicating a higher degree of goal attainment.	Baseline, Post-Intervention (immediately following 4 weeks of intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Indicator: Recruitment Rate	Number of participants recruited.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Retention Rate	Percentage of participants with post-intervention data.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Perceived Benefit of Telerehabilitation	Satisfaction survey administered at the end of the post-intervention visit.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Treatment Fidelity	Percentage of telerehabilitation sessions attended, exercise completed during telerehabilitation sessions, self-managed exercise plans completed.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Participant Burden	Percentage of participants with pre- and post-assessments.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Participant Burden 2	Duration to complete the assessments.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Assessor Burden	Duration to complete the assessments.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Therapist Burden	Time spent administering the telerehabilitation session.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Ease of Using Equipment	Downtime due to technical issues of tablet and video-conferencing platform.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Processing Time	Time from initial contact to enrolment.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Incidence of Treatment-Emergent Adverse Events (Safety)	Adverse events from the telerehabilitation sessions or assessments.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Treatment Response	Paired sample t-test.	Post-Intervention (immediately following 4 weeks of intervention)
Feasibility Indicator: Treatment Effect	Estimate of effect size and variance for future sample size calculations.	Post-Intervention (immediately following 4 weeks of intervention)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Brodie Sakakibara, PhD, University of British Columbia; Principal Investigator: Ada Tang, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Telerehabilitation; Lower extremity
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Infarction; Stroke; Cardiovascular Diseases; Vascular Diseases; Ischemic Stroke; Brain Ischemia; Nervous System Diseases; Brain Diseases; Cerebral Infarction; Hemorrhagic Stroke; Cerebrovascular Disorders; Brain Infarction; Central Nervous System Diseases
• Other Study ID Numbers: TRAIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No