"Remind-to-move" Using Wearable Devices in Home-based Treatment for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Fugl-Meyer Assessment-Upper Extremity Score
研究概览
简要总结
This is a multi-centered randomized controlled trial to investigate the effects of "Remind-to-Move" (RTM) using wearable devices at home for promoting upper extremity recovery in stroke patients after discharge from subacute hospitals.
详细描述
This is a proof-of-principle study to investigate the effects of "Remind-to-Move" (RTM) using wearable devices at home for promoting upper extremity recovery in stroke patients after discharge from subacute hospitals.
A multi-center, parallel-group, randomized controlled trial with blinded assessment was carried out in four hospitals. Eighty-four eligible participants who had suffered from stroke with less than 6 months and could slightly move their arms were randomly allocated to either an experimental, sham, or control group stratified by hemiplegic arm functional levels. Patients in the experimental group were treated by RTM using wearable devices, 3 consecutive hours daily, for 4 weeks. The sham group used sham devices. The control group received the usual care. A masked assessor evaluated the participants at 0, 4th, 8th and 12th weeks. Outcome measures included arm function tests, motor activity log, movement amount and percentage recorded by wearable devices. All patients allocated to treatment were included in intention-to-treat analysis.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frst-time ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging or X-ray computed tomography
- •Unilateral hemispherical involvement
- •Aged 18 or above
- •Time since onset less than 6 months
- •Functional Test for Hemiplegic Upper Extremity Hong Kong version (FTHUE-HK) ≥ 3 (maximum 7)
- •Able to understand verbal instruction and follow one-step commands
- •Modified Ashworth Scale (MAS) ≤ 2
- •Mini-mental State Examination (MMSE) ≥ 19
- •No complaint of excessive pain or swelling over hemiplegic arm
- •Sensation on the affected wrist intact or with mild impairment only (National Institute of Health Stroke Scale=0 or 1).
排除标准
- •Participating in any experimental or drug study
- •Unable to give consent to participate
- •Of inadequate balance as indicated by the inability to stand for at least 2 minutes with or without arm support
- •Having history of botulinum toxin injection in 3 months.
结局指标
主要结局
Fugl-Meyer Assessment-Upper Extremity Score
时间窗: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Hemiplegic arm motor impairment scale
次要结局
- Functional Independence Measure(Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week)
- Motor Activity Log(Change from 4-week to follow-ups at 8-week and 12-week)
- Accelerometry in wristwatch devices(Change from Baseline to 4-week)
- Box and Block Test(Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week)
- Action Research Arm Test(Change from Baseline to 4-week, and follow-ups at 8-week and 12-week)