Department of Occupational Science and Occupational Therapy, The University of British Columbia, Vancouver, British Columbia, Canada
Centre for Chronic Disease Prevention and Management, The University of British Columbia Okanagan, Kelowna, British Columbia, Canada.
BMJ Open. 2023 Jul 19;13(7):e076723. doi: 10.1136/bmjopen-2023-076723.
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).
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 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.
ClinicalTrials.gov, NCT04908241.
远程康复是一种可及的服务提供模式，它可以支持创新的下肢康复计划，将卒中康复连续体延伸到社区。不幸的是，关于使用远程康复提供的卒中后下肢恢复的运动治疗方案的证据有限。有鉴于此，我们开发了旨在改善卒中后下肢恢复的远程康复（TRAIL）计划，这是一个为期 4 周的渐进式运动和自我管理干预计划，通过视频会议技术同步进行。我们的主要假设是，在卒中后 1 年内接受 TRAIL 的个体在功能性移动能力方面的改善将明显大于接受注意力控制教育计划（EDUCATION）的个体。
在这项多中心、平行组、评估者盲法随机对照注意力控制试验中，96 名卒中后 1 年内居住在社区的幸存者将从加拿大 CanStroke Recovery Trials Platform 的五个地点（温哥华、温尼伯、多伦多、伦敦和哈利法克斯）招募，该平台是一个由加拿大医院组成的网络，这些医院与学术机构有关联，以促进参与者招募和高质量试验实践。参与者将按 1:1 的比例随机分配到 TRAIL 或 EDUCATION。随机分配到 TRAIL 的参与者将接受 8 次远程康复治疗，在治疗过程中，他们将进行运动治疗并接受自我管理支持，以改善下肢康复，由 TRAIL 物理治疗师进行治疗。主要结局将使用计时起立行走测试进行测量。次要结局包括下肢肌肉力量、功能平衡、运动障碍、平衡自我效能、健康相关生活质量和健康服务使用，以进行我们的经济评估。测量将在基线、干预结束时、3 个月和 6 个月后进行。
所有参与的地点都已获得这项研究的伦理批准。所有研究参与者将在参与研究之前提供他们的知情同意。这项试验的结果将在同行评议的期刊上发表，并在国际科学会议上展示。
ClinicalTrials.gov，NCT04908241。
