Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke

Stroke Clinical Trial

— TRAIL  

Official title:

Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265664
• Other study ID #: TRAIL
• Status: Completed
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Infarction
• Brain Ischemia
• Cardiovascular Diseases
• Central Nervous System Diseases
• Cerebral Infarction
• Cerebral Vascular Disorder
• Cerebrovascular Disorders
• Hemorrhagic Stroke
• Infarction
• Ischemic Stroke
• Nervous System Diseases
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	Parkwood Institute	London	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Canada	Riverview Health Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility Indicator: Recruitment Rate	Number of participants recruited.	Post-Intervention (immediately following 4 weeks of intervention)
Other	Feasibility Indicator: Retention Rate	Percentage of participants with post-intervention data.	Post-Intervention (immediately following 4 weeks of intervention)
Other	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)
Other	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)
Other	Feasibility Indicator: Participant Burden	Percentage of participants with pre- and post-assessments.	Post-Intervention (immediately following 4 weeks of intervention)
Other	Feasibility Indicator: Participant Burden 2	Duration to complete the assessments.	Post-Intervention (immediately following 4 weeks of intervention)
Other	Feasibility Indicator: Assessor Burden	Duration to complete the assessments.	Post-Intervention (immediately following 4 weeks of intervention)
Other	Feasibility Indicator: Therapist Burden	Time spent administering the telerehabilitation session.	Post-Intervention (immediately following 4 weeks of intervention)
Other	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)
Other	Feasibility Indicator: Processing Time	Time from initial contact to enrolment.	Post-Intervention (immediately following 4 weeks of intervention)
Other	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)
Other	Feasibility Indicator: Treatment Response	Paired sample t-test.	Post-Intervention (immediately following 4 weeks of intervention)
Other	Feasibility Indicator: Treatment Effect	Estimate of effect size and variance for future sample size calculations.	Post-Intervention (immediately following 4 weeks of intervention)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	modified virtual Fugl-Meyer Assessment	Performance measure to assess lower extremity impairment.	Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Secondary	30 second Sit to Stand	Performance measure used to assess lower extremity strength.	Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Secondary	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)