Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke

NCT ID: NCT04265664

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2021-09-30

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.

Conditions

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

Keywords

Telerehabilitation; Lower extremity; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telerehabilitation

Receives the telerehabilitation protocol

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Brodie Sakakibara

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ada Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Brodie Sakakibara, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Riverview Health Centre

Winnipeg, Manitoba, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

Parkwood Institute

London, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

TRAIL

Identifier Type: -

Identifier Source: org_study_id