Encouragement-induced Movement Therapy in Daily Life (ISEAR)
Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device
Stroke places a major burden on health care and society. It often leads to a hemiparesis. Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. Applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. Up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage.
The primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. The secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. It is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up.
ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Vitznau、瑞士
- Cereneo, Center For Neurology and Rehabilitation
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Wald、瑞士
- Zürcher RehaZentrum Wald
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Zürich、瑞士
- University Hospital Zurich
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke)
- Ability to lift arm against gravity (>30 degrees flexion or abduction)
- Ability to don/doff the devices on both wrists independently or with assistance of a caregiver
- Ability to give informed consent as documented by signature
Exclusion Criteria:
- Major untreated depression
- Severe cognitive impairment
- Suffering from comprehensive aphasia
- Severely impaired sensation (unable to feel a soft touch on the dorsal side of their paretic wrist with closed eyes)
- Other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic dysfunction, orthopedic disorders, etc.)
- Expected hospitalization during study period
- Known intolerance to device material
- Known or suspected non-compliance, drug or alcohol abuse
- The investigator, his/her family members, employees, and other dependent persons
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Monitoring and Feedback
Subjects will use two wrist-worn wearables over a period of 6 weeks.
Patients will receive multimodal (vibrotactile and visual) feedback.
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See arm/group description.
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安慰剂比较：Monitoring
Study subjects will use identical devices over a period of 6 weeks.
Patients will *not* receive multimodal feedback.
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See arm/group description.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Motor Activity Log - 14, Amount of Use sub scale
大体时间：Post-intervention (6 weeks)
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Self-reported amount of upper limb use in daily life
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Post-intervention (6 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fugl-Meyer Assessment, Upper Extremity sub scale
大体时间：Post-intervention (6 weeks)
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Upper limb motor function
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Post-intervention (6 weeks)
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Fugl-Meyer Assessment, Upper Extremity sub scale
大体时间：Follow-up (12 weeks)
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Upper limb motor function
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Follow-up (12 weeks)
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Action Research Arm Test
大体时间：Post-intervention (6 weeks)
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Upper limb capacity
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Post-intervention (6 weeks)
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Action Research Arm Test
大体时间：Follow-up (12 weeks)
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Upper limb capacity
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Follow-up (12 weeks)
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Modified Rankin Scale
大体时间：Post-intervention (6 weeks)
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Global Disability
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Post-intervention (6 weeks)
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Modified Rankin Scale
大体时间：Follow-up (12 weeks)
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Global Disability
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Follow-up (12 weeks)
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EuroQol five dimensions five levels questionnaire
大体时间：Post-intervention (6 weeks)
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Quality of Life
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Post-intervention (6 weeks)
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EuroQol five dimensions five levels questionnaire
大体时间：Follow-up (12 weeks)
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Quality of Life
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Follow-up (12 weeks)
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Motor Activity Log - 14, Quality of Movement sub scale
大体时间：Post-intervention (6 weeks)
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Self-reported quality of upper limb use in daily life
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Post-intervention (6 weeks)
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Motor Activity Log - 14, Quality of Movement sub scale
大体时间：Follow-up (12 weeks)
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Self-reported quality of upper limb use in daily life
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Follow-up (12 weeks)
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Motor Activity Log - 14, Amount of Use sub scale
大体时间：Follow-up (12 weeks)
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Self-reported amount of upper limb use in daily life
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Follow-up (12 weeks)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Global Rating of Perceived Change
大体时间：Post-intervention (6 weeks)
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Post-intervention (6 weeks)
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Global Rating of Perceived Change
大体时间：Follow-up (12 weeks)
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Follow-up (12 weeks)
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Concomitant movement therapy
大体时间：Post-intervention (6 weeks)
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Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)
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Post-intervention (6 weeks)
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Concomitant movement therapy
大体时间：Follow-up (12 weeks)
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Follow-up (12 weeks)
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Adverse Events
大体时间：Baseline (0 week)
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Safety
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Baseline (0 week)
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Adverse Events
大体时间：Post-intervention (6 weeks)
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Safety
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Post-intervention (6 weeks)
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Adverse Events
大体时间：Follow-up (12 weeks)
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Safety
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Follow-up (12 weeks)
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合作者和调查者
调查人员
- 首席研究员：Andreas R Luft, Prof. MD、University of Zurich
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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