Reaching the Unreached: Randomized Trial of Home-Based Telerehabilitation for Stroke Without Outpatient Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE)
研究概览
简要总结
After a stroke, many people have trouble using their arms and hands. This can make daily tasks-like eating, dressing, or writing-very hard. In Alberta, especially in small towns and rural areas, many stroke survivors go home from the hospital without being referred to rehabilitation. As a result, they miss out on therapy that could help them get better.
This project will test a new way to bring rehabilitation directly into people's homes using telerehabilitation. We will work with 200 stroke survivors across Alberta who did not get regular outpatient rehab. Participants will use the clinically validated Tenzr system-a set of fun, game-like exercises with wearable sensors. Therapists will check in and guide them remotely.
When participants are enrolled in the study, they will be randomized (1:1) into two groups. The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline, while the Delayed group will receive 8 weeks of observation (usual care) followed by 8 weeks of the same telerehabilitation intervention. Everyone in the study will be tested at the baseline, 8 weeks, and 16 weeks. At 16 weeks, we will also interview them to gather their feedback on the telerehabilitation. We want to learn if this program helps people improve arm and hand movement, if it's easy to use, and if people like it. We also want to see if it could be offered more widely across Alberta in the future.
The goal is to give more people access to stroke rehabilitation, no matter where they live.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not currently referred to, or participating in, upper extremity outpatient rehabilitation.
- •A confirmed stroke diagnosis (ischemic or hemorrhagic)
- •Have moderate-to-severe upper limb impairment
- •Live at home
- •Have access to internet and appropriate devices to have a virtual assessment with clinicians.
- •≥ 18 years of age
排除标准
- •Referred to or currently participating in upper extremity outpatient rehabilitation.
- •Severe cognitive, communication, or medical comorbidities that would preclude safe home-based exercise
- •Don't have access to internet and appropriate devices to have a virtual assessment with clinicians.
- •< 18 years of age
研究组 & 干预措施
Immediate Group
The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline clinical assessments.
干预措施: Standard of Care (SOC) (Other)
Immediate Group
The Immediate group will receive 8 weeks of home-based telerehabilitation using the Tenzr platform immediately after baseline clinical assessments.
干预措施: Telerehabilitation with Tenzr (Other)
Delayed Group
Delayed group will receive 8 weeks of observation (usual care) following the baseline clinical assessment; followed by 8 weeks of the same telerehabilitation intervention.
干预措施: Standard of Care (SOC) (Other)
Delayed Group
Delayed group will receive 8 weeks of observation (usual care) following the baseline clinical assessment; followed by 8 weeks of the same telerehabilitation intervention.
干预措施: Telerehabilitation with Tenzr (Other)
结局指标
主要结局
Change in Upper Extremity Fugl-Meyer Assessment for Upper Extremity (FM-UE)
时间窗: Baseline, 8 weeks and 16 weeks.
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. We will be obtaining and reporting the Upper Extremity subscore. It is a score without units.
次要结局
- Change in Nine-hole Peg Test (NHPT) (sec)(Baseline, 8 weeks, 16 weeks)
- Change in Box and Blocks Test (number of blocks)(Baseline, 8 weeks, 16 weeks)
- Change in Stroke Impact Scale Score(Baseline, 8 weeks, 16 weeks)
- Change in PROMIS Upper Extremity Short Form(Baseline, 8 weeks, 16 weeks)