Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke

Not Applicable

Completed

• Conditions: Brain Diseases; Central Nervous System Diseases; Stroke; Brain Ischemia; Brain Infarction; Infarction; Stroke, Ischemic; Cerebral Vascular Disorder; Stroke Hemorrhagic; Cerebral Infarction
• Interventions: Behavioral: Telerehabilitation

• Registration Number: NCT04265664
• Lead Sponsor: University of British Columbia

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2020-07-28
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telerehabilitation	Telerehabilitation	Receives the telerehabilitation protocol

Primary Outcome Measures

Name	Time	Method
Change from baseline Timed Up and Go (TUG) at 4 weeks	Baseline, Post-Intervention (immediately following 4 weeks of intervention)	Performance walking test to assess functional mobility.

Secondary Outcome Measures

Name	Time	Method
Stroke Impact Scale (SIS)	Baseline, Post-Intervention (immediately following 4 weeks of intervention)	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.
Activities-Specific Balance (ABC) Scale	Baseline, Post-Intervention (immediately following 4 weeks of intervention)	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.
Functional Reach	Baseline, Post-Intervention (immediately following 4 weeks of intervention)	Performance measure to assess balance through maximal forward reach (in cm) from a fixed base.
Goal Attainment Scale	Baseline, Post-Intervention (immediately following 4 weeks of intervention)	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.
Tandem Stand	Baseline, Post-Intervention (immediately following 4 weeks of intervention)	Performance measure to assess balance through holding a tandem stance position (up to 10 seconds; alternate positions: semi-tandem or feet together).
modified virtual Fugl-Meyer Assessment	Baseline, Post-Intervention (immediately following 4 weeks of intervention)	Performance measure to assess lower extremity impairment.
30 second Sit to Stand	Baseline, Post-Intervention (immediately following 4 weeks of intervention)	Performance measure used to assess lower extremity strength.

Trial Locations

Locations (5)

Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Riverview Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Parkwood Institute; 🇨🇦 London, Ontario, Canada