StrokeTRAILNCT04265664
Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke
A study testing Telerehabilitation 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 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. 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?
- Telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesCanada
- Study dates
- 28 Jul 2020to 30 Sep 2021
- 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 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;
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Dalhousie University
Halifax, Nova Scotia, B3H 4R2
Parkwood Institute
London, Ontario, N6C 5J1
University Health Network
Toronto, Ontario, M5G 2C4
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
Riverview Health Centre
Winnipeg, Manitoba, R3L 2P4
About this study
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.
Read the 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.
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Cerebral Infarction, Brain Diseases, Central Nervous System Diseases
- Being tested
- Telerehabilitation
- Keywords
- Telerehabilitation, Lower extremity, Stroke
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Cerebral Infarction, Brain Diseases, Central Nervous System Diseases, Cerebrovascular Disorders, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Receives the telerehabilitation protocol Receives: Behavioral: Telerehabilitation |
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)
Secondary outcomes (7)
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.
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
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.
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
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)
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)
modified virtual Fugl-Meyer Assessment
Performance measure to assess lower extremity impairment.
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
30 second Sit to Stand
Performance measure used to assess lower extremity strength.
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
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.
Measured: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start28 Jul 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, pre-post study design
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brodie Sakakibara, University of British Columbia
- Investigators
- Ada Tang, PhD, Principal investigator, McMaster UniversityBrodie Sakakibara, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265664
- Sponsor's protocol ID
- TRAIL
- Acronym
- TRAIL
- Status last verified
- Dec 2022
- First submitted
- 28 Jan 2020
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park S, Tang A, Barclay R, Bayley M, Eng JJ, Mackay-Lyons M, Pollock C, Pooyania S, Teasell R, Yao J, Sakakibara BM. Investigating the Telerehabilitation With Aims to Improve Lower Extremity Recovery Poststroke Program: A Feasibility Study. Phys Ther. 2024 Mar 1;104(3):pzad165. doi: 10.1093/ptj/pzad165.
PubMed 38051660
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. 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
- ClinicalTrials.gov ID
- NCT04265664
- Acronym / sponsor ID
- TRAIL / TRAIL
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Cerebral Infarction, Brain Diseases, Central Nervous System Diseases
- Keywords
- Telerehabilitation, Lower extremity, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 11 Feb 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, pre-post study design
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Behavioral: TelerehabilitationReceives the telerehabilitation protocol |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| TelerehabilitationParticipants 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. | Behavioural | Telerehabilitation |
Primary outcome
Change from baseline Timed Up and Go (TUG) at 4 weeks
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Performance walking test to assess functional mobility.
7 secondary outcomes
Stroke Impact Scale (SIS)
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Activities-Specific Balance (ABC) Scale
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Tandem Stand
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Functional Reach
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
modified virtual Fugl-Meyer Assessment
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
30 second Sit to Stand
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Goal Attainment Scale
Time frame: Baseline, Post-Intervention (immediately following 4 weeks of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 38051660Park S, Tang A, Barclay R, Bayley M, Eng JJ, Mackay-Lyons M, Pollock C, Pooyania S, Teasell R, Yao J, Sakakibara BM. Investigating the Telerehabilitation With Aims to Improve Lower Extremity Recovery Poststroke Program: A Feasibility Study. Phys Ther. 2024 Mar 1;104(3):pzad165. doi: 10.1093/ptj/pzad165.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Ada Tang, PhD principal investigator
McMaster University
Brodie Sakakibara, PhD principal investigator
University of British Columbia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 22 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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)). 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 NCT04265664, 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 Dec 2022.