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Clinical Trials/NCT04265664
NCT04265664CompletedNot Applicable

Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke

University of British Columbia5 sites in 1 country32 target enrollmentStarted: July 28, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
5
Primary Endpoint
Change from baseline Timed Up and Go (TUG) at 4 weeks

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Telerehabilitation

Experimental

Receives the telerehabilitation protocol

Intervention: Telerehabilitation (Behavioral)

Outcomes

Primary Outcomes

Change from baseline Timed Up and Go (TUG) at 4 weeks

Time Frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)

Performance walking test to assess functional mobility.

Secondary Outcomes

  • Stroke Impact Scale (SIS)(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • Activities-Specific Balance (ABC) Scale(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • Functional Reach(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • Goal Attainment Scale(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • Tandem Stand(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • modified virtual Fugl-Meyer Assessment(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • 30 second Sit to Stand(Baseline, Post-Intervention (immediately following 4 weeks of intervention))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brodie Sakakibara

Assistant Professor

University of British Columbia

Study Sites (5)

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