Evaluating Error Augmentation for Neurorehabilitation (VREA)
2015年9月23日 更新者：James Patton、Shirley Ryan AbilityLab
This is a sub-project of a larger NIDRR Grant.
One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation.
In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control.
Using the VRROOM, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results.
This project evaluates a practical approach of error augmentation, using therapist-driven trajectories.
The investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities.
The investigators will test two experimental treatments in a crossover design.
The investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery.
研究概览
研究类型
介入性
注册 (实际的)
40
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。
学习地点
-
-
Illinois
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Chicago、Illinois、美国、60611
- Rehabilitation Institute of Chicago
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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 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- adult (age >18)
- survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (MCA),
- demonstrated the presence of some active shoulder and elbow movement (characterized by Fugl-Meyer Assessment Upper Extremity scores ranging from 15-50 for ARM 1; 25-50 for ARM 2).
Exclusion Criteria:
- diffuse or multiple lesion sites or multiple stroke events
- bilateral paresis
- severe spasticity or contracture (Modified Ashworth ≥3
- severe concurrent medical problems
- severe sensory deficits
- cerebellar strokes resulting in severe ataxia
- significant shoulder pain
- focal tone management with Botulinim Toxin (Botox®) injection to the hemiparetic upper extremity (UE) within the previous four months,
- aphasia that would influence the ability to perform the experiment
- cognitive impairment (Mini Mental State Examination < 23/30)
- affective dysfunction that would influence the ability to perform the experiment
- depth perception impairment (< 3 on Stereo Circle Test)
- visual field cut or hemispatial neglect that would influence the ability to participate in the activity
- inability to provide informed consent
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：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Error Augmentation-Control
|
error augmentation for arm motor recovery in individuals with stroke
其他名称：
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实验性的：Control-Error Augmentation
|
error augmentation for arm motor recovery in individuals with stroke
其他名称：
|
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 |
|---|---|---|
|
Arm motor recovery scores on the Fugl-Meyer
大体时间：Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks for ARM 1; at start of week 1 (pre-eval), end of week 2 (post), and end of week 3 (1 week follow-up) for ARM 2)
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Change from baseline in arm motor recovery as measured by Fugl-Meyer
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Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks for ARM 1; at start of week 1 (pre-eval), end of week 2 (post), and end of week 3 (1 week follow-up) for ARM 2)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of blocks transferred in Box and Blocks Test
大体时间：same as primary
|
Change from baseline in number of blocks transferred during Box and Blocks Test
|
same as primary
|
|
Time and Quality of movement scores on the Wolf Motor Function Test
大体时间：same as primary
|
Change from baseline in arm motor recovery as measured by time scores and ability scores on the Wolf Motor Function test
|
same as primary
|
|
Time scores and Ability scores on the Assessment of Simple Functional Reach Test
大体时间：same as primary (not used for ARM 2)
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Change from baseline in arm motor recovery as measured by time scores and ability scores on the Assessment of Simple Functional Reach Test
|
same as primary (not used for ARM 2)
|
|
Quantity and Quality with Motor Activity Log
大体时间：same as primary but added for ARM 2
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Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity
|
same as primary but added for ARM 2
|
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：James Patton, PhD、Shirley Ryan Abilitylab
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
2008年1月1日
初级完成 (实际的)
2012年3月1日
研究完成 (实际的)
2012年3月1日
研究注册日期
首次提交
2012年2月28日
首先提交符合 QC 标准的
2012年4月8日
首次发布 (估计)
2012年4月10日
研究记录更新
最后更新发布 (估计)
2015年9月24日
上次提交的符合 QC 标准的更新
2015年9月23日
最后验证
2015年9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.