Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL)
Primary Purpose
Stroke, Stroke, Ischemic, Stroke Hemorrhagic
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Telerehabilitation, Lower extremity, Stroke
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
Sites / Locations
- University of British Columbia
- Riverview Health Centre
- Dalhousie University
- Parkwood Institute
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telerehabilitation
Arm Description
Receives the telerehabilitation protocol
Outcomes
Primary Outcome Measures
Change from baseline Timed Up and Go (TUG) at 4 weeks
Performance walking test to assess functional mobility.
Secondary Outcome Measures
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.
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.
Tandem Stand
Performance measure to assess balance through holding a tandem stance position (up to 10 seconds; alternate positions: semi-tandem or feet together).
Functional Reach
Performance measure to assess balance through maximal forward reach (in cm) from a fixed base.
modified virtual Fugl-Meyer Assessment
Performance measure to assess lower extremity impairment.
30 second Sit to Stand
Performance measure used to assess lower extremity strength.
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.
Full Information
NCT ID
NCT04265664
First Posted
January 28, 2020
Last Updated
December 21, 2022
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04265664
Brief Title
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke
Acronym
TRAIL
Official Title
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-group, pre-post study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Receives the telerehabilitation protocol
Intervention Type
Behavioral
Intervention Name(s)
Telerehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Timed Up and Go (TUG) at 4 weeks
Description
Performance walking test to assess functional mobility.
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Secondary Outcome Measure Information:
Title
Stroke Impact Scale (SIS)
Description
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.
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Title
Activities-Specific Balance (ABC) Scale
Description
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.
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Title
Tandem Stand
Description
Performance measure to assess balance through holding a tandem stance position (up to 10 seconds; alternate positions: semi-tandem or feet together).
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Title
Functional Reach
Description
Performance measure to assess balance through maximal forward reach (in cm) from a fixed base.
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Title
modified virtual Fugl-Meyer Assessment
Description
Performance measure to assess lower extremity impairment.
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Title
30 second Sit to Stand
Description
Performance measure used to assess lower extremity strength.
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Title
Goal Attainment Scale
Description
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.
Time Frame
Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Other Pre-specified Outcome Measures:
Title
Feasibility Indicator: Recruitment Rate
Description
Number of participants recruited.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Retention Rate
Description
Percentage of participants with post-intervention data.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Perceived Benefit of Telerehabilitation
Description
Satisfaction survey administered at the end of the post-intervention visit.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Treatment Fidelity
Description
Percentage of telerehabilitation sessions attended, exercise completed during telerehabilitation sessions, self-managed exercise plans completed.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Participant Burden
Description
Percentage of participants with pre- and post-assessments.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Participant Burden 2
Description
Duration to complete the assessments.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Assessor Burden
Description
Duration to complete the assessments.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Therapist Burden
Description
Time spent administering the telerehabilitation session.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Ease of Using Equipment
Description
Downtime due to technical issues of tablet and video-conferencing platform.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Processing Time
Description
Time from initial contact to enrolment.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Incidence of Treatment-Emergent Adverse Events (Safety)
Description
Adverse events from the telerehabilitation sessions or assessments.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Treatment Response
Description
Paired sample t-test.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
Title
Feasibility Indicator: Treatment Effect
Description
Estimate of effect size and variance for future sample size calculations.
Time Frame
Post-Intervention (immediately following 4 weeks of intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ada Tang, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brodie Sakakibara, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4R2
Country
Canada
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke
We'll reach out to this number within 24 hrs