Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 10
- 主要终点
- Change from baseline Timed Up and Go (TUG) at 4 weeks
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to participants' group allocation, whereby they will not be involved with delivering the TRAIL or EDUCATION programs. Participants are informed of their group assignment, however they will not know if they are in the experimental or control program, and instructed to withhold it from the assessors to ensure proper blinding and minimize internal bias.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
结局指标
主要结局
Change from baseline Timed Up and Go (TUG) at 4 weeks
时间窗: Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months
Performance walking test to assess functional mobility
次要结局
- Activities-Specific Balance (ABC) Scale(Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months)
- Functional Reach(Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months)
- Stroke Impact Scale (SIS)(Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months)
- 30 second Sit to Stand(Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months)
- Modified Virtual Fugl-Meyer Assessment(Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months)
- Health Resource Utilization Questionnaire(Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months)
- Health-related quality of life (EuroQol-5D-5 Level)(Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months)
- Tandem Stand(Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months)
研究者
Brodie Sakakibara
Assistant Professor
University of British Columbia