Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
2014年1月3日 更新者：US Department of Veterans Affairs
The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME.
A control group receives additional occupational therapy without the use of MIME.
研究概览
详细说明
This study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke.
These hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with MIME in the initial phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention.
Research Plan - A multi-site clinical trial is in progress at the Houston VA Medical Center (VAMC), the VA Greater Los Angeles Health Care System (GLAHCS), the VA Palo Alto Rehabilitation Research and Development Center (RR&DC), and the Central Texas Veterans Health Care System (CTVHCS).
CTVHCS serves as the coordinating site.
The RR&DC provides training and technical assistance for the other sites.
Methods - Subjects with hemiparesis due to a stroke are randomly assigned to 3 groups.
Group 1 receives 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy.
Group 2 receives a total of 2 hours/day of robot-assisted therapy.
Group 3 receives 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot.
Outcome measures include assessment of strength, motor control, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.
研究类型
介入性
注册 (实际的)
71
阶段
- 第三阶段
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
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California
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Palo Alto、California、美国、94304-1290
- VA Palo Alto Health Care System
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West Los Angeles、California、美国、90073
- VA Greater Los Angeles Healthcare System, West LA
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Texas
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Houston、Texas、美国、77030
- Michael E. DeBakey VA Medical Center (152)
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Temple、Texas、美国、76504
- Central Texas Veterans Health Care System
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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
21年 及以上 (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:
- Over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. Subjects are inpatients at one of the participating VA hospitals.
Exclusion Criteria:
Unable to follow instructions; medically unstable.
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Robot-Low
low-dose mechanically-assisted upper limb therapy
|
1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
|
|
实验性的：Robot-High
high-dose mechanically-assisted upper limb therapy
|
2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
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|
有源比较器：Control
additional traditional therapy
|
1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
|
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 |
|---|---|---|
|
Fugl-Meyer Score Change Immediately Following Study Intervention.
大体时间：After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
|
Change in Fugl-Meyer Assessment (FMA) score.
The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score.
It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke.
Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain.
Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully.
Subscales can be administered without the using the full test.
For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66.
A greater increase in the score represents a greater improvement in upper limb motor function.
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After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
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Fugl-Meyer Score Change at 6 Months
大体时间：FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.
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Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline.
Maximum score = 66.
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FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in FIM Score Immediately Following Study Intervention.
大体时间：After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
|
Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL).
The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL.
It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task).
Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63).
A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.
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After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
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Change in FIM Score at 6-months
大体时间：Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.
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Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63 . |
Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.
|
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：Charles Burgar, MD、Central Texas Veterans Health Care System
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2002年1月1日
初级完成 (实际的)
2008年7月1日
研究完成 (实际的)
2008年7月1日
研究注册日期
首次提交
2005年9月14日
首先提交符合 QC 标准的
2005年9月14日
首次发布 (估计)
2005年9月22日
研究记录更新
最后更新发布 (估计)
2014年2月17日
上次提交的符合 QC 标准的更新
2014年1月3日
最后验证
2014年1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.
Robot-Low的临床试验
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Cook Research Incorporated完全的
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University of PittsburghPatient-Centered Outcomes Research Institute招聘中
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Mitsubishi Tanabe Pharma CorporationThe Research Foundation for Microbial Diseases of Osaka University完全的