Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke

NCT04265664 | Completed

• 1 other identifier: TRAIL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• Tandem Stand

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

• Functional Reach

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

• modified virtual Fugl-Meyer Assessment

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

Other Outcomes (13)

• Feasibility Indicator: Recruitment Rate

  Post-Intervention (immediately following 4 weeks of intervention)

• Feasibility Indicator: Retention Rate

  Post-Intervention (immediately following 4 weeks of intervention)

• Feasibility Indicator: Perceived Benefit of Telerehabilitation

  Post-Intervention (immediately following 4 weeks of intervention)

Study Arms (1)

Telerehabilitation

EXPERIMENTAL

Receives the telerehabilitation protocol

Behavioral: Telerehabilitation

Interventions

Telerehabilitation 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.

Telerehabilitation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (5)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Riverview Health Centre

Winnipeg, Manitoba, R3L 2P4, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Parkwood Institute

London, Ontario, N6C 5J1, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Cerebral Infarction; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Brain Ischemia; Brain Infarction; Cardiovascular Diseases; Infarction

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Vascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ada Tang, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Brodie Sakakibara, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single-group, pre-post study design

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 11, 2020
• Study Start: July 28, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)