StrokeTRAIL-RCTNCT04908241
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT)
A study testing TRAIL and EDUCATION in people with Stroke and Stroke, Ischemic, run by University of British Columbia at 5 sites in Canada.
Trial summary
The purpose of this study is to compare the effectiveness of a 4-week lower extremity telerehabilitation protocol with aims to improve lower extremity function to a 4-week attention-controlled education program on lower extremity clinical outcomes, quality of life, and healthcare resources utilization among community… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- TRAIL and EDUCATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 5 sitesCanada
- Study dates
- 8 Nov 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥19 years of age, ≤12 months post-stroke with lower extremity hemiparesis
- Able to walk ≥10 meters with or without a gait aid and without physical assistance of another person
- Can tolerate 50 minutes of activity (including rest breaks)
- Has cognitive-communicative ability to participate, per clinical judgement
- Able to provide consent
- Has a caregiver, friend, or family member available to provide physical support during the assessment sessions
Who cannot join
- Currently participating in formal in- or out-patient stroke rehabilitation focusing on lower extremity training
- Living in long-term care
- Severe vision or hearing loss
- Significant musculoskeletal or other neurological conditions
- Not medically stable
- Comorbidities (e.g. limb amputation), pain or other symptoms that significantly impact lower extremity function
- Planned surgery that would preclude or affect participation in the protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Parkwood Institute
London, Ontario, N6C 5J1
Alexandria Roa Agudelo, (519) 646-6100 ext. 42570, alexandria.roaagudelo@sjhc.london.on.ca
Arden Lawson, BMSc, (519) 646-6100 ext. 42570, arden.lawson@sjhc.london.on.ca
- Recruiting
Dalhousie University
Nova Scotia, Halifax, B3H 4R2
Melanie Dunlop, 905-473-1401, melanie.dunlop@nshealth.ca
Judy Lugar, 902-225-6003, judy@lugar.ca
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Olga Yaroslavtseva, 416-876-4823, olga.yaroslavtseva@uhn.ca
Mark Bayley, MD FRCPC
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
Elise A Wiley, MSc, (289) 214-1569, wileye@mcmaster.ca
Brodie Sakakibara, PhD, (250) 807-8505, brodie@mail.ubc.ca
- Recruiting
Riverview Health Centre
Winnipeg, Manitoba, R3L 2P4
Olayinka Akinrolie, akinrolo@myumanitoba.ca
Anuprita Kanitkar, 204-881-3112, Anuprita.Kanitkar@umanitoba.ca
About this study
Official title: Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial
The purpose of this study is to compare the effectiveness of a 4-week lower extremity telerehabilitation protocol with aims to improve lower extremity function to a 4-week attention-controlled education program on lower extremity clinical outcomes, quality of life, and healthcare resources utilization among community dwelling adults with stroke across Canada.
Read the detailed description
With an aging population, and survival rates now at 83% in Canada, the number of stroke survivors is expected to reach 720,000 by 2038. While 90% of individuals with stroke return to independent community living, 80% report residual motor impairment, such as loss or limitation in motor control, or mobility limitation. These limitations have profound effects on the ability to perform everyday activities and are associated with substantial economic strain on the healthcare system. Thus, a primary focus of stroke rehabilitation is on the recovery of motor function, walking and balance, using exercise via physical therapy.
The rapid growth in Internet use and personal mobile devices has opened an array of possibilities for stroke survivors to remotely access specialized rehabilitation from their homes and communities (i.e., telerehabilitation). Telerehabilitation interventions have been used effectively for check-in sessions, education, and counselling after stroke, but knowledge of the effectiveness of using telerehabilitation for the delivery of exercise interventions for lower extremity recovery is limited.
The investigators developed the TeleRehabilitation with Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL) to address the unmet needs for lower extremity rehabilitation after stroke, and the need for accessible rehabilitation in the face of the COVID-19 pandemic. TRAIL is an exercise program designed to promote lower extremity recovery using technology with real-time therapist instruction and guidance. The investigators recently conducted a proof-of-concept, single-group feasibility study of TRAIL (TRAIL-PROOF). From TRAIL-PROOF, there were have no reports of serious adverse events and 100% retention of participants. Preliminary analysis of 32 individuals completed also suggest improvements in the clinical outcomes, including increased lower extremity strength, functional balance, and balance self-efficacy. Thus, from TRAIL-PROOF, it is evident that the TRAIL protocol has potential to improve lower extremity function among community-dwelling adults with stroke experiencing lower extremity impairment. The investigators now propose a full-scaled randomized controlled trial to further study the TRAIL program (TRAIL-RCT).
The objectives for TRAIL-RCT are as follows:
- The primary objective is to compare functional mobility (Timed Up and Go, primary clinical outcome) after 4 weeks of TRAIL to a 4-week attention-controlled education program (EDUCATION) in individuals ≤12 months post-stroke;
- The secondary objective is to compare the 4-week TRAIL and EDUCATION programs on secondary outcomes of:
- Lower extremity strength (30-Second Sit-to Stand test);
- Functional balance (Tandem Stand and Functional Reach);
- Motor impairment (Virtual Fugl-Meyer Assessment);
- Balance self-efficacy (Activities-specific Balance Confidence Scale);
- The tertiary objective is to compare the 4-week TRAIL and EDUCATION programs on health economic outcomes:
- Health-related quality of life (Stroke Impact Scale, EuroQol-5D-5 Level); and
- Health resources and costs (Health Resource Utilization Questionnaire)
- The quaternary objective is to evaluate the feasibility of a subsequent larger multisite implementation stepped wedge randomized trial of TRAIL using pre-specified criteria related to process, resources, management, and scientific indicators.
It is hypothesized that:
The primary hypothesis is that the 4-week TRAIL program will lead to greater improvement in functional mobility, as measured by the Timed Up and Go, compared to the 4-week EDUCATION program in individuals ≤12 months post-stroke (Objective 1, primary clinical outcome).
The investigators also anticipate that greater improvements will be observed in the secondary clinical outcomes, in the areas of lower extremity muscle strength, motor impairment, functional balance, and balance self-efficacy, following TRAIL compared to EDUCATION (Objective 2).
The tertiary hypothesis is that the TRAIL intervention will demonstrate superior health economic outcomes compared to the EDUCATION group (Objective 3).
The quaternary hypothesis is that the protocol will demonstrate sufficient feasibility (e.g., rates of recruitment/retention, treatment fidelity and adherence, safety, treatment effects) to support a subsequent larger multi-site implementation stepped wedge randomized controlled trial (Objective 4).
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Cerebral Injury, Cerebral Infarction, Brain Diseases
- Being tested
- TRAIL, EDUCATION
- Keywords
- Telerehabilitation, Lower Extremity, Self-Management, Education, Secondary Prevention, Stroke, Exercise
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Brain Injuries, Cerebral Infarction, Brain Diseases, Central Nervous System Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAILOther
Each week has a specific focus for lower extremity rehabilitation:
Week 1) Building a base: 8 exercises, 10-15 repetitions x 2-3 sets
Week 2) Increasing repetitions: 8 exercises, 15-20 repetitions x 3 sets
Week 3) Building exercise tolerance:10 exercises, 15-20 repetitions x 3 sets
Week 4) Maximizing repetitions: 10 exercises, 30 seconds as many reps as possible x 2 sets
At the end of the second exercise session each week, the therapist and participants work collaboratively to develop an independent exercise action plan to be completed before the first session of the next week. The self-managed plans includes exercises selected from TRAIL, agreed upon by the participant and therapist, that are safe to perform without therapist oversight. The aims of the exercise action plan are to: i) Add exercise volume without using program resources (e.g., therapist time); and ii) Build capacity for self-management for long-term health and well-being after TRAIL has ended.
EDUCATIONOther
EDUCATION has a specific focus on:
Week 1) What is stroke (e.g., gaining an understanding of the function of the brain, types of stroke and how stroke affects physical function) and introduction to self-management;
Week 2) What is self-management;
Week 3) Self-management for post-stroke complications (e.g., activities of daily living);
Week 4) Self-management for secondary prevention (e.g., blood pressure, diet, medication, stress management).
Education therapists will be provided with lesson plans and manuals to be circulated with the participants, and will facilitate the educational session through interactive Powerpoint presentations. In addition, participants will be asked to complete 30-60 minutes of educational homework, which will be discussed at the commencement of the following session.
| Study group | Role | What they receive |
|---|---|---|
| TRAIL | Experimental | TRAIL is a 4-week progressive exercise and self-management intervention for lower extremity recovery delivered by a trained registered physical therapist, in a 2:1 participant-to-therapist ratio. Each participant grouping will receive two telerehabilitation sessions (60-90 minutes) each week for 4 weeks (total 8-12 hours). Receives: Other: TRAIL |
| EDUCATION | Active comparator | The EDUCATION control arm is a 4-week education program focusing on stroke knowledge and risk factors. It will be delivered by health professionals who have experience working with individuals with stroke, knowledge of chronic disease self-management (e.g. physical or occupational therapists, nurses, kinesiologists), and who have completed study-specific training on the EDUCATION program
Participants will receive video conferencing sessions with the same schedule and 2:1 participant-to-coach ratio as TRAIL. Each participant grouping will receive two educational telerehabilitation sessions (60-90 minutes) each week for 4 weeks (total 8-12 hours). Receives: Other: EDUCATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Timed Up and Go (TUG) at 4 weeks
Performance walking test to assess functional mobility
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Secondary outcomes (8)
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 participant rates his/her difficulty completing the task from 1 to 5, where lower scores mean greater difficulty to complete the item.
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
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 participant to rate their confidence in performing the activity from 0% to 100%, where higher percentages indicate greater self-efficacy
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Functional Reach
Performance measure to assess balance through maximal forward reach (in cm) from a fixed base
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Modified Virtual Fugl-Meyer Assessment
Performance measure to assess lower extremity impairment
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
30 second Sit to Stand
Performance measure used to assess lower extremity strength
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Health Resource Utilization Questionnaire
Health care utilization calculated by assessing health professional visits, admissions to hospital, laboratory tests/ investigations, and use of medications
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Health-related quality of life (EuroQol-5D-5 Level)
A generic preference-based utility instrument composed of 5 domains of health (mobility, self-care, usual activities, pain, anxiety/depression), each with 5 levels (1=no problems, 5=major problems), which is often used to calculate cost-utility
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Tandem Stand
Performance measure to assess balance through holding a tandem stance position (up to 10 seconds; alternate positions: semi-tandem or feet together
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start8 Nov 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following baseline assessment, participants will be randomized into the TRAIL or EDUCATION arm. Following randomization, participants will remain in their allocated group until the completion of the study. A central research coordinator that is not involved in recruitment, assessments or study intervention, will be responsible for randomization of study participants, and will advise the participant and site coordinator of the group allocation. There will be four timepoints where outcome assessments will be conducted, which include baseline (T0), 1-month (T1), 3-months (T2), and 6-months (T3) follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Brodie Sakakibara, University of British Columbia
- Investigators
- Brodie Sakakibara, PhD, Principal investigator, University of British ColumbiaAda Tang, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908241
- Sponsor's protocol ID
- TRAIL-RCT
- Acronym
- TRAIL-RCT
- Status last verified
- Jun 2023
- First submitted
- 20 May 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form will be shared with qualified researchers engaging in independent scientific research, upon request to the research team.
Publications
Sakakibara BM, Wiley E, Barclay R, Bayley M, Davis JC, Eng JJ, Harris A, Inness EL, MacKay-Lyons M, Monaghan J, Pollock C, Pooyania S, Schneeberg A, Teasell R, Yao J, Tang A. TeleRehabilitation with Aims to Improve Lower extremity recovery in community-dwelling individuals who have had a stroke: protocol for a multisite, parallel group, assessor-blinded, randomised attention-controlled trial. BMJ Open. 2023 Jul 19;13(7):e076723. doi: 10.1136/bmjopen-2023-076723.
PubMed 37474180
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04908241
- Acronym / sponsor ID
- TRAIL-RCT / TRAIL-RCT
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Cerebral Injury, Cerebral Infarction, Brain Diseases
- Keywords
- Telerehabilitation, Lower Extremity, Self-Management, Education, Secondary Prevention, Stroke, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of a 4-week lower extremity telerehabilitation protocol with aims to improve lower extremity function to a 4-week attention-controlled education program on lower extremity clinical outcomes, quality of life, and healthcare resources utilization among community dwelling adults with stroke across Canada.
Detailed description
With an aging population, and survival rates now at 83% in Canada, the number of stroke survivors is expected to reach 720,000 by 2038. While 90% of individuals with stroke return to independent community living, 80% report residual motor impairment, such as loss or limitation in motor control, or mobility limitation. These limitations have profound effects on the ability to perform everyday activities and are associated with substantial economic strain on the healthcare system. Thus, a primary focus of stroke rehabilitation is on the recovery of motor function, walking and balance, using exercise via physical therapy.
The rapid growth in Internet use and personal mobile devices has opened an array of possibilities for stroke survivors to remotely access specialized rehabilitation from their homes and communities (i.e., telerehabilitation). Telerehabilitation interventions have been used effectively for check-in sessions, education, and counselling after stroke, but knowledge of the effectiveness of using telerehabilitation for the delivery of exercise interventions for lower extremity recovery is limited.
The investigators developed the TeleRehabilitation with Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL) to address the unmet needs for lower extremity rehabilitation after stroke, and the need for accessible rehabilitation in the face of the COVID-19 pandemic. TRAIL is an exercise program designed to promote lower extremity recovery using technology with real-time therapist instruction and guidance. The investigators recently conducted a proof-of-concept, single-group feasibility study of TRAIL (TRAIL-PROOF). From TRAIL-PROOF, there were have no reports of serious adverse events and 100% retention of participants. Preliminary analysis of 32 individuals completed also suggest improvements in the clinical outcomes, including increased lower extremity strength, functional balance, and balance self-efficacy. Thus, from TRAIL-PROOF, it is evident that the TRAIL protocol has potential to improve lower extremity function among community-dwelling adults with stroke experiencing lower extremity impairment. The investigators now propose a full-scaled randomized controlled trial to further study the TRAIL program (TRAIL-RCT).
The objectives for TRAIL-RCT are as follows:
- The primary objective is to compare functional mobility (Timed Up and Go, primary clinical outcome) after 4 weeks of TRAIL to a 4-week attention-controlled education program (EDUCATION) in individuals ≤12 months post-stroke;
- The secondary objective is to compare the 4-week TRAIL and EDUCATION programs on secondary outcomes of:
- Lower extremity strength (30-Second Sit-to Stand test);
- Functional balance (Tandem Stand and Functional Reach);
- Motor impairment (Virtual Fugl-Meyer Assessment);
- Balance self-efficacy (Activities-specific Balance Confidence Scale);
- The tertiary objective is to compare the 4-week TRAIL and EDUCATION programs on health economic outcomes:
- Health-related quality of life (Stroke Impact Scale, EuroQol-5D-5 Level); and
- Health resources and costs (Health Resource Utilization Questionnaire)
- The quaternary objective is to evaluate the feasibility of a subsequent larger multisite implementation stepped wedge randomized trial of TRAIL using pre-specified criteria related to process, resources, management, and scientific indicators.
It is hypothesized that:
The primary hypothesis is that the 4-week TRAIL program will lead to greater improvement in functional mobility, as measured by the Timed Up and Go, compared to the 4-week EDUCATION program in individuals ≤12 months post-stroke (Objective 1, primary clinical outcome).
The investigators also anticipate that greater improvements will be observed in the secondary clinical outcomes, in the areas of lower extremity muscle strength, motor impairment, functional balance, and balance self-efficacy, following TRAIL compared to EDUCATION (Objective 2).
The tertiary hypothesis is that the TRAIL intervention will demonstrate superior health economic outcomes compared to the EDUCATION group (Objective 3).
The quaternary hypothesis is that the protocol will demonstrate sufficient feasibility (e.g., rates of recruitment/retention, treatment fidelity and adherence, safety, treatment effects) to support a subsequent larger multi-site implementation stepped wedge randomized controlled trial (Objective 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Following baseline assessment, participants will be randomized into the TRAIL or EDUCATION arm. Following randomization, participants will remain in their allocated group until the completion of the study. A central research coordinator that is not involved in recruitment, assessments or study intervention, will be responsible for randomization of study participants, and will advise the participant and site coordinator of the group allocation. There will be four timepoints where outcome assessments will be conducted, which include baseline (T0), 1-month (T1), 3-months (T2), and 6-months (T3) follow-up.
| Arm | Type | Receives |
|---|---|---|
| TRAIL | Experimental | Other: TRAILTRAIL is a 4-week progressive exercise and self-management intervention for lower extremity recovery delivered by a trained registered physical therapist, in a 2:1 participant-to-therapist ratio. Each participant grouping will receive two telerehabilitation sessions (60-90 minutes) each week for 4 weeks (total 8-12 hours). |
| EDUCATION | Active comparator | Other: EDUCATIONThe EDUCATION control arm is a 4-week education program focusing on stroke knowledge and risk factors. It will be delivered by health professionals who have experience working with individuals with stroke, knowledge of chronic disease self-management (e.g. physical or occupational therapists, nurses, kinesiologists), and who have completed study-specific training on the EDUCATION program Participants will receive video conferencing sessions with the same schedule and 2:1 participant-to-coach ratio as TRAIL. Each participant grouping will receive two educational telerehabilitation sessions (60-90 minutes) each week for 4 weeks (total 8-12 hours). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥19 years of age, ≤12 months post-stroke with lower extremity hemiparesis
- Able to walk ≥10 meters with or without a gait aid and without physical assistance of another person
- Can tolerate 50 minutes of activity (including rest breaks)
- Has cognitive-communicative ability to participate, per clinical judgement
- Able to provide consent
Key exclusion criteria (7 listed)
- Currently participating in formal in- or out-patient stroke rehabilitation focusing on lower extremity training
- Living in long-term care
- Severe vision or hearing loss
- Significant musculoskeletal or other neurological conditions
- Not medically stable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAILEach week has a specific focus for lower extremity rehabilitation: Week 1) Building a base: 8 exercises, 10-15 repetitions x 2-3 sets Week 2) Increasing repetitions: 8 exercises, 15-20 repetitions x 3 sets Week 3) Building exercise tolerance:10 exercises, 15-20 repetitions x 3 sets Week 4) Maximizing repetitions: 10 exercises, 30 seconds as many reps as possible x 2 sets At the end of the second exercise session each week, the therapist and participants work collaboratively to develop an independent exercise action plan to be completed before the first session of the next week. The self-managed plans includes exercises selected from TRAIL, agreed upon by the participant and therapist, that are safe to perform without therapist oversight. The aims of the exercise action plan are to: i) Add exercise volume without using program resources (e.g., therapist time); and ii) Build capacity for self-management for long-term health and well-being after TRAIL has ended. | Other | TRAIL |
| EDUCATIONEDUCATION has a specific focus on: Week 1) What is stroke (e.g., gaining an understanding of the function of the brain, types of stroke and how stroke affects physical function) and introduction to self-management; Week 2) What is self-management; Week 3) Self-management for post-stroke complications (e.g., activities of daily living); Week 4) Self-management for secondary prevention (e.g., blood pressure, diet, medication, stress management). Education therapists will be provided with lesson plans and manuals to be circulated with the participants, and will facilitate the educational session through interactive Powerpoint presentations. In addition, participants will be asked to complete 30-60 minutes of educational homework, which will be discussed at the commencement of the following session. | Other | EDUCATION |
Primary outcome
Change from baseline Timed Up and Go (TUG) at 4 weeks
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Performance walking test to assess functional mobility
8 secondary outcomes
Stroke Impact Scale (SIS)
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Activities-Specific Balance (ABC) Scale
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Functional Reach
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Modified Virtual Fugl-Meyer Assessment
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
30 second Sit to Stand
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Health Resource Utilization Questionnaire
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Health-related quality of life (EuroQol-5D-5 Level)
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Tandem Stand
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 37474180Sakakibara BM, Wiley E, Barclay R, Bayley M, Davis JC, Eng JJ, Harris A, Inness EL, MacKay-Lyons M, Monaghan J, Pollock C, Pooyania S, Schneeberg A, Teasell R, Yao J, Tang A. TeleRehabilitation with Aims to Improve Lower extremity recovery in community-dwelling individuals who have had a stroke: protocol for a multisite, parallel group, assessor-blinded, randomised attention-controlled trial. BMJ Open. 2023 Jul 19;13(7):e076723. doi: 10.1136/bmjopen-2023-076723.
- Individual participant dataSharing planned: Yes. The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form will be shared with qualified researchers engaging in independent scientific research, upon request to the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brodie Sakakibara, PhD principal investigator
University of British Columbia
Ada Tang, PhD principal investigator
McMaster University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAIL and EDUCATION in people with Stroke and Stroke, Ischemic, run by University of British Columbia at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise A Wiley, MSc ((289) 214-1569, wileye@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Timed Up and Go (TUG) at 4 weeks (time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.