Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke (ARTHE)
2012年12月10日 更新者：Lore Van de Perre、Thomas More Kempen
Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.
研究概览
详细说明
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.
研究类型
介入性
注册 (预期的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Lore Van de Perre, MSc
- 电话号码：+32 14 56 23 10
- 邮箱：lore.van.de.perre@khk.be
学习地点
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-
Antwepen
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Geel、Antwepen、比利时、2440
- Thomas More Kempen
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接触：
- Lore Van de Perre, MSc
- 电话号码：+32 14 56 23 10
- 邮箱：lore.van.de.perre@khk.be
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接触：
- Peter Karsmakers, PhD
- 电话号码：+32 14 56 23 10
- 邮箱：peter.karsmakers@khk.be
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首席研究员：
- Lore Van de Perre, MSc
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副研究员：
- Roy Sevit, MSc
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副研究员：
- Koen Janssens, MSc
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副研究员：
- Peter Karsmakers, PhD
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副研究员：
- Louis Peeraer, Prof.PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with stroke, more than three months post onset
- No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
- Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
- Able to sit on a chair with adequate trunk stability
- Able to follow verbal instructions
- Able to communicate verbal information to the researchers
Exclusion Criteria:
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 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：Training with the device
Training with new upper limb robot assisted therapy device
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During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
其他名称：
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无干预：Control group
The control group is treated with conventional therapy.
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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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Fugl-Meyer test upper limb section
大体时间：Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Stroke specific, performance based impairment index.
Applied to determine disease severity and describe motor recovery.
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Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
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Medical research council score
大体时间：Change from baseline Medical research council score at 8 weeks and 12 weeks
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Muscle strength assessment
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Change from baseline Medical research council score at 8 weeks and 12 weeks
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Active range of motion of the elbow joint
大体时间：Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
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Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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Passive range of motion of the elbow joint
大体时间：Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
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Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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Modified Ashworth Scale
大体时间：Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
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Spasticity measurement
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Change from baseline Modified Ashworth Scale at 8 weeks and 12 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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ABILHAND questionnaire
大体时间：Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Questionnaire-based assessment of manual ability
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Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
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Functional independence measure
大体时间：Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Assessment of physical and cognitive disability, focusing on the burden of care.
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Change from baseline Functional independence measure score at 8 weeks and 12 weeks
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Stroke impact scale
大体时间：Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Questionnaire evaluating how stroke has impacted the person's health and life.
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Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
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Intrinsic motivation inventory
大体时间：Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
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Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Lore Van de Perre, MSc、Thomas More Kempen
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年2月1日
初级完成 (预期的)
2014年7月1日
研究完成 (预期的)
2014年9月1日
研究注册日期
首次提交
2012年10月30日
首先提交符合 QC 标准的
2012年11月5日
首次发布 (估计)
2012年11月7日
研究记录更新
最后更新发布 (估计)
2012年12月11日
上次提交的符合 QC 标准的更新
2012年12月10日
最后验证
2012年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.