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Protocol
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
  1. Brodie M Sakakibara1,2,
  2. Elise Wiley3,
  3. Ruth Barclay4,
  4. Mark Bayley5,
  5. Jennifer C Davis6,
  6. Janice J Eng7,8,
  7. Anne Harris9,
  8. Elizabeth L Inness10,
  9. Marilyn MacKay-Lyons11,
  10. Jennifer Monaghan2,
  11. Courtney Pollock7,8,
  12. Sepideh Pooyania12,
  13. Amy Schneeberg13,
  14. Robert Teasell14,15,
  15. Jennifer Yao9,
  16. Ada Tang3
  1. 1Department of Occupational Science and Occupational Therapy, The University of British Columbia, Vancouver, British Columbia, Canada
  2. 2Centre for Chronic Disease Prevention and Management, The University of British Columbia Okanagan, Kelowna, British Columbia, Canada
  3. 3School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada
  4. 4College of Rehabilitation Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
  5. 5Division of Physical Medicine and Rehabilitation, University of Toronto, Toronto, Ontario, Canada
  6. 6Faculty of Management, The University of British Columbia Okanagan, Kelowna, British Columbia, Canada
  7. 7Department of Physical Therapy, The University of British Columbia, Vancouver, British Columbia, Canada
  8. 8GF Strong Rehabilitation Research Program, Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada
  9. 9GF Strong Rehabilitation Centre, Vancouver Coastal Health Authority, Vancouver, British Columbia, Canada
  10. 10Mobility Innovations Centre, Toronto Rehabiltiation Institute, Toronto, Ontario, Canada
  11. 11School of Physiotherapy, Dalhousie University, Halifax, Nova Scotia, Canada
  12. 12Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
  13. 13Consultant, The University of British Columbia, Vancouver, British Columbia, Canada
  14. 14Lawson Health Research Unit, Parkwood Hospital, London, Ontario, Canada
  15. 15Physical Medicine and Rehabiliation, University of Western Ontario, London, Ontario, Canada
  1. Correspondence to Dr Brodie M Sakakibara; brodie.sakakibara{at}ubc.ca

Abstract

Introduction Telerehabilitation is an accessible service delivery model that may support innovative lower extremity rehabilitation programmes that extend the stroke recovery continuum into the community. Unfortunately, there is limited evidence on the provision of exercises for lower extremity recovery after stroke delivered using telerehabilitation. In response, we developed the TeleRehabilitation with Aims to Improve Lower extremity recovery poststroke (TRAIL) programme, a 4-week progressive exercise and self-management intervention delivered synchronously using video-conferencing technology. Our primary hypothesis is that individual within 1-year poststroke who participate in TRAIL will experience significantly greater improvements in functional mobility than individuals in an attention-controlled education programme (EDUCATION).

Methods and analysis In this multisite, parallel group, assessor-blinded randomised attention-controlled trial, 96 community-living stroke survivors within 1-year poststroke will be recruited from five sites (Vancouver, Winnipeg, Toronto, London and Halifax, Canada) from the CanStroke Recovery Trials Platform which is a network of Canadian hospital sites that are affiliated with academic institutions to facilitate participant recruitment and quality trial practices. Participants will be randomised on a 1:1 basis to TRAIL or EDUCATION. Participants randomised to TRAIL will receive eight telerehabilitation sessions where they will perform exercises and receive self-management support to improve lower extremity recovery from a TRAIL physical therapist. The primary outcome will be measured using the Timed Up and Go. Secondary outcomes include lower extremity muscle strength, functional balance, motor impairment, balance self-efficacy, health-related quality of life and health service use for our economic evaluation. Measurements will be taken at baseline, immediately after the intervention, 3-month and 6-month postintervention.

Ethics and dissemination Ethics approval for this research has been obtained by all participating sites. All study participants will provide their informed consent prior to enrolling them in the study. Findings from this trial will be disseminated in peer-reviewed journals and presentations at international scientific meetings.

Trial registration number ClinicalTrials.gov, NCT04908241.

  • stroke
  • telemedicine
  • rehabilitation medicine
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2023-076723

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    Strengths and limitations of this study

    • This randomised controlled trial studies the effect of TeleRehabilitation with Aims to Improve Lower extremity recovery (TRAIL) in community-dwelling individuals who have had a stroke, compared with an attention-controlled education programme.

    • In addition to examining the effect of TRAIL on lower extremity clinical outcomes, including functional mobility, strength and balance, our cost-utility analysis will examine the incremental costs and effects generated by using the TRAIL intervention compared with education.

    • This is a multisite national trial on the CanStroke Recovery Trials Platform.

    • Our volunteer sample may contribute to selection bias among participants, as the individuals who choose to participate may have greater interest to exercise and partake in rehabilitation programmes or have the necessary resources to participate in a virtual programme.

    • Study recruitment is primarily from larger hospitals affiliated with academic institutions which may limit the number of participants from rural and remote locations.

    Introduction

    Much has been done to improve survival rates after stroke1 and return individuals to independent community living.2 Longer-term care and rehabilitation after hospital discharge remain underdeveloped,3 with stroke survivors receiving minimal to no follow-up rehabilitation after returning to the community.4 Increasing demands on the limited service capacity of our healthcare system have led to suboptimal recovery of lower extremity function among individuals with stroke. This has resulted in greater disability and higher systemic costs.

    Telerehabilitation is an accessible service delivery model that may be able to support innovative lower extremity rehabilitation programmes that extend the stroke recovery continuum into the community.5 Unfortunately, there is limited evidence on the provision of exercises for lower extremity recovery delivered using telerehabilitation,6 primarily due to the unique safety challenges. Exercise via physical rehabilitation is the gold standard for lower extremity recovery after stroke.7 A large body of literature indicates that lower extremity exercises delivered in-person and face-to-face improve independence, walking, mobility and balance in stroke survivors.8–10 Moreover, exercise improves psychosocial outcomes after stroke, such as self-efficacy related to balance and falls,11 participation in social and community activities,12 and quality of life. Typically, exercise programmes for lower-extremity recovery that focus on mobility and balance have been delivered in-person to manage safety issues and risks of falls. Thus, while telerehabilitation interventions have been used effectively for check-in sessions, education and counselling after stroke,13 there is minimal evidence on the use of telerehabilitation for lower extremity recovery poststroke.

    In response, we developed the TeleRehabilitation with Aims to Improve Lower extremity recovery poststroke (TRAIL) programme.14 TRAIL is a 4-week progressive exercise and self-management intervention delivered synchronously using video-conferencing technology in a ≤2:1 participant to physical therapist ratio. In our single-group pre-post feasibility study (n=32), we observed high participant satisfaction with TRAIL, treatment fidelity and adherence, no serious adverse events or dropouts. We also observed positive trends in clinical outcomes, including mobility (Timed Up and Go (TUG)), lower extremity impairment (Fugl-Meyer Assessment) and strength (30 s sit to stand), and balance confidence (Activity-specific Balance Confidence scale).14 In this paper, we report on the study protocol evaluating TRAIL in a phase 3, multisite randomised controlled trial. Our primary hypothesis is that individuals within 1-year poststroke who participate in TRAIL will experience greater improvements (p<0.05) in functional mobility of the lower extremity (measured using TUG) immediately following the intervention than individuals in an attention-controlled education programme (EDUCATION) focusing on stroke risk factor control. Our secondary hypotheses are that TRAIL participants will improve lower extremity muscle strength, functional balance, motor impairment, balance self-efficacy and reduce health service use compared with participants in EDUCATION over 3 and 6 months postintervention.

    Methods and analysis

    The reporting of this protocol follows the Standard Protocol Items: Recommendations for Intervention Trials15 guidelines. The study has received ethics from all participating sites and is registered with ClinicalTrials.gov (NCT04908241). Study recruitment started on 2 June 2021. As of 19 June 2023, we have recruited 42 participants.

    Trial design

    We will use a multisite, parallel group, assessor-blinded randomised attention-controlled trial to address our study hypotheses. Figure 1 provides an overview of trial procedures, outcomes and programmes.

    Figure 1
    Figure 1

    Trial flowchart.

    Patient population

    Volunteer participants will be recruited from five sites (Vancouver, Winnipeg, Toronto, London and Halifax, Canada) from the CanStroke Recovery Trials Platform which is a network of Canadian hospital sites that are affiliated with academic institutions to facilitate participant recruitment and quality trial practices. Individuals will be included if they: are at least 19 years of age and within 12 months poststroke (we have revised this criteria from our previous feasibility study from 18 months to 12 months to capture window of opportunity for neuroplasticity); have lower extremity hemiparesis; can walk at least 10 m; can tolerate 50 min of activity; and have cognitive-communicative ability to participate. Individuals will be excluded if they: are currently participating in formal in-patient or out-patient rehabilitation for lower extremity recovery; live in long-term care; have severe vision or hearing loss; have significant musculoskeletal or other neurological conditions; are not medically stable; or have comorbid conditions that influence their lower extremity function.

    Randomisation

    Stratified permuted block randomisation will occur with random block sizes of 4 and 6 stratified by sex (man or woman). Participants will be randomised (1:1 allocation) to either TRAIL or EDUCATION using a computer-generated sequence. Allocation concealment will be in place, and randomisation will be completed by a researcher not involved with recruitment, data collection or intervention delivery.

    Interventions

    Experimental

    Participants randomised to TRAIL receive:

    • Virtual Intake Session and Home Assessment: Prior to starting TRAIL, therapists will conduct a 30-min 1:1 session to meet with participants, confirm health status and impairment level, ensure that the technology is functioning and that the home set-up is appropriate for the intervention.

    • Exercise: Participants will receive two synchronous telerehabilitation sessions (60–90 min) each week for 4 weeks, at ≤2:1 participant-to-physical therapist ratio. Each week has a specific focus for lower extremity rehabilitation: Week 1, building a base; Week 2, increasing repetitions; Week 3, building exercise tolerance; and Week 4, maximising repetitions. The protocol is standardised, but exercises are adaptable to accommodate individual abilities. Preparticipation checklists are completed prior to every session to verify participants’ health and well-being, ensure that technology is working and confirm emergency contact information.

    • Self-management support: At the end of the second exercise session each week, the therapist and participants will work collaboratively to develop an independent exercise action plan to be completed before the first session of the next week. The self-managed plans include exercises selected from TRAIL, agreed on by the participant and therapist, that are safe to perform without therapist oversight. The aims of the exercise action plan are to: (1) add exercise volume without using programme resources (eg, therapist time) and (2) build capacity for self-management for long-term health and well-being after TRAIL has ended.

    TRAIL therapists are registered physical therapists who have experience working with people with stroke. They will complete a 3-hour training curriculum on: (1) telerehabilitation; (2) exercise for lower-extremity recovery poststroke; (3) self-management support; (4) the TRAIL protocol, including training on the comprehensive safety protocol and (4) practice. Therapists also receive a comprehensive TRAIL Therapist Manual, Exercise Guide, videos and other resources, as well as the Participant Manual. Fidelity of TRAIL will be enhanced by our detailed protocols, close supervision, recording and auditing of TRAIL sessions, and monthly therapist meetings with the study research team for support, dialogue and information sharing.

    Attention control

    Participants randomised too EDUCATION receive:

    • Two synchronous educational sessions (60–90 min) each week for 4 weeks with a trained educator at ≤2:1 participant-to-educator ratio, that controls for attention and expectancy of improvement resulting from TRAIL. EDUCATION has a specific focus on: Week 1, what is stroke; Week 2, what is self-management; Week 3, self-management for poststroke complications (eg, activities of daily living); and Week 4, self-management for secondary prevention (eg, blood pressure, diet and stress management).

    • A manual that provides information about stroke, self-management, poststroke complication, stroke risk factors and secondary prevention, as well as homework.

    Educators are professionals with experience working with individuals with stroke, knowledge of chronic disease self-management, and who have completed study-specific training on the EDUCATION programme. Similar to TRAIL, fidelity of EDUCATION will be enhanced by our detailed protocols, close supervision, auditing of EDUCATION sessions and monthly meetings with the study research team for support, dialogue and information sharing.

    Assessments

    Participants will be followed for 7 months. After receiving informed consent (online supplemental file 1), all outcome measures will be administered virtually at baseline (T1), the end of the 4-week intervention period (T2) to determine training-associated changes in outcomes; 3 months postintervention (T3) to evaluate retention of benefits; and 6 months postintervention (T4) to ensure a robust economic evaluation.16 We have established the safety, feasibility and test-retest reliability of the virtual outcomes assessments.17 During assessments, we may require a helper (eg, family and friend) to be present to help with set-up, safety and supervision. All assessors will be physical therapists who are not involved in administering TRAIL or EDUCATION, and blinded to group allocation. They will receive a 2-hour training workshop, comprehensive Assessor Manual, videos and other resources.

    At T1, we will also collect demographic data including age, sex, details of stroke (type and location), gender-related factors such as gender identity, employment, partner status, living arrangements, caregiving, household roles, social support, independence and education, comorbidities (Functional Comorbidity Index),18 stroke severity (modified Rankin Scale19 and NIH Stroke Severity Scale),20 and cognition (Montreal Cognitive Assessment-Short).21 At T2, we will also administer a user acceptability survey to assess participants’ attitudes, satisfaction. For participants who deviate from intervention protocols, we will continue with follow-up data collection on all study outcomes.

    Primary and secondary outcomes

    Primary clinical outcome

    Our primary outcome is the between-group difference in functional mobility at postintervention, measured using the TUG.22 The time (seconds) to rise from a standard armchair, walk 3 m at a comfortable pace, turn and return to sitting in the chair is the primary outcome of the test. The test has excellent test-retest reliability (Intraclass Correlation Coefficient (ICC) = 0.96)23 and high convergent validity with the Berg Balance Scale (rho=−0.70) and Community Balance and Mobility Scale (rho=−0.75).24

    Secondary clinical outcomes

    (1) Lower extremity strength will be assessed using a 30 s Sit-to-Stand test25 where participants begin by sitting in a standard chair with their arms crossed, and complete as many repetitions of sitting to standing as possible within 30 s. The number of completed repetitions is the primary outcome of this test. This measure has excellent test-retest reliability among older adults (r=0.89).25 (2) Functional balance is assessed using Functional Reach and Tandem Stand. Functional Reach assesses balance through maximum distance of forward reach (in cm) from a fixed base. It has been validated with walking speed, tandem walk and 1-footed stand, and has excellent test-retest reliability.26 27 We will also measure the ability to hold a tandem stance position (up to 10 s; alternate positions: semitandem or feet together).28 (3) Motor impairment is evaluated using a modified 12-item Fugl-Meyer Assessment which rates lower extremity impairment, coordination and speed on a three-point scale (0=cannot perform, 1=performs partially and 2=performs fully).29 The maximum score is 24, with higher scores indicating less impairment. (4) Balance self-efficacy is assessed using the 16-item Activities-specific Balance Confidence Scale, a self-report questionnaire that measures an individual’s self-efficacy in performing various activities without losing balance.30 Item responses range between 0 and 100, where a mean score is derived, with higher scores indicating higher balance self-efficacy. (5) Health-related quality of life is assessed using the 60-item Stroke Impact Scale.31 Participants rate the level of difficulty for strength, hand function, basic and instrumental activities of daily living, mobility, communication, emotion, memory and thinking, and participation on a five-point Likert scale. The scale has excellent concurrent validity with the Functional Independence Measure (r=0.83), Barthel Index (r=0.82) and the SF-36 (r=0.84).32

    Health economic outcomes

    Health resource use will be collected using a healthcare resource utilisation questionnaire.33 On a per participant basis, costs will be assigned using hospital costing models and the provincial guides to medical fees. Health-related quality of life will be evaluated using the EuroQol-5D-5 Level,34 a generic preference-based utility instrument comprises five domains related to health (mobility, self-care, usual activities, pain and anxiety/depression), each with five levels (1=no problems and 5=major problems); a health state utility value will be calculated from the scores on each of these five domains. Lower scores indicate poorer health-related quality of life; a score lower than zero indicates a health state considered worse than death. We will use Canadian conversion tariffs for transforming health state profiles into utility scores.35

    Feasibility indicators

    Data on process (recruitment rate, retention rate and perceived satisfaction), resources (treatment fidelity and adherence, blinding, randomisation, study criteria, participant and assessor burden), management (equipment and processing time) and scientific (safety) parameters will be collected throughout the study, beginning at baseline.36

    Data management and monitoring

    All participating sites will use REDCap to collect the study outcomes. Any adverse events related to the intervention will be reported by the study coordinators and followed up by the research steering committee (RSC). The RSC will perform day-to-day trial management and meet on a weekly basis and will provide overall supervision, monitor trial progress and advise on scientific credibility.

    Sample size estimate

    Based on our feasibility study with an SD of 9.6 s of the virtual/online TUG as our primary clinical outcome, we require a sample size of 74 participants to detect a clinically important difference of 5 s37 between groups, at a level of significance of 0.05 (two-sided), with 80% power (G*Power, V.3.1.9.7, Düsseldorf GER). To account for 20% attrition, we will recruit 93 participants, plus another 3 participants to ensure the 2:1 participant-to-therapist ratio for each of the TRAIL and EDUCATION groups, for a total of 96 participants (48 per study arm). Our previous work has found very low ICCs (<0.01) for walking and mobility outcomes across six Canadian stroke rehabilitation centres.38 Thus, clustering by site was not considered in the sample size calculation.

    Statistical analysis

    Means and SDs (continuous variables) and frequencies and proportions (categorical variables) will be used to summarise all variables at baseline.

    Clinical outcomes

    Intervention effects postintervention (T2) will be estimated using linear regression including baseline measures and the sex stratification variable as covariates. Linear mixed effects models will be used for the secondary endpoints (T3 and T4) with time by treatment group as an interaction term and ID as a random effect. Interaction of treatment group with baseline will also be explored. All analyses will be intention-to-treat. Analyses will be performed using R software (R Foundation, Vienna) with significance at 0.05.

    Health economic outcome

    Our cost-utility analysis will examine the incremental costs and effects generated by using the TRAIL intervention compared with EDUCATION. The outcome of the cost-utility analysis is the incremental cost-utility ratio (ICUR).39 The ICUR represents the difference between the mean costs of providing the intervention compared with the control divided by the difference in mean effectiveness, where the ICUR = ∆ Cost/∆ Utility (eg, ∆ Quality Adjusted Life Year (QALY)).39 The QALY is calculated based on the quality of life of a participant (ie, estimated from the EQ-5D-5L health state utility values) in a given health state and the time spent in that health state.

    Feasibility indicators

    Feasibility indicators will be treated as binary, with ‘success’ indicating that the indicator is sufficient with only small or no adaptations required and ‘revise’ indicating a need for changes prior to implementing TRAIL.

    Patient and public involvement

    An individual with lived experience of stroke (JM) is a member of our RSC, has advised on the development of TRAIL, this trial protocol and outcome measures, and meets weekly with the research team.

    Ethics and dissemination

    Ethics approval for this research has been obtained by all participating sites (University of British Columbia Clinical Research Ethics Board (H21-01317); University of Manitoba Health Research Ethics Board (HS25245); Toronto and London via Clinical Trials Ontario (3786); and Nova Scotia Health Research Ethics Board (1 027 411)). Prior to enrolling individuals into the study, a research coordinator will detail the study procedures to potential participants and answer any questions. After providing informed consent (online supplemental file 1), individuals will be enrolled into the study. This article describes protocol V.1.7. Any amendment to this protocol will be sent to the ethics committee for approval. Findings from this trial will be disseminated in peer-reviewed journals and presentations at international scientific meetings.

    Ethics statements

    Patient consent for publication

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    Footnotes

    • Twitter @DocMarkBayley

    • Contributors BMS and AT conceived the study concept and design and will provide overall oversight of trial progress, data management and analyses, and knowledge translation. EW, RB, MB, JCD, JJE, AH, ELI, MM-L, JM, CP, SP, AS, RT and JY will contribute to the study protocol implementation, patient screening, and data acquisition and analyses. AS will provide statistical expertise. EW will handle the configuration of the database and data collection management. All authors provided critical review and approved the final version of this manuscript.

    • Funding This work is supported by: Canadian Institutes of Health Research Project Grant (PJT-178201); Michael Smith Health Research BC Scholar Award (BMS, JCD, CP); Ontario Heart & Stroke Foundation Clinician-Scientist Award (Phase II) (AT); AGEWELL/McMaster Institute for Research on Aging scholarship (EW); Tier 1 Canada Research Chair (CRC) in Neurological Rehabilitation (JJE); Tier 2 CRC in Applied Health Economics (JCD). We also thank the CanStroke Recovery Trials Platform for supporting the recruitment of this trial and the Brain Canada Foundation for their support of the Platform. Study funders had no role in the study design, collection, management, analysis, or interpretation of data.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.