Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke
2020年2月9日 更新者：Joon-Ho Shin、National Rehabilitation Center, Seoul, Korea
Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
研究概览
研究类型
介入性
注册 (实际的)
30
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
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-
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Seoul、大韩民国、142884
- National Rehabilitation Center
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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
19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:
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score 3
- 3 months ≤ Onset ≤ 12 months
- Korean Mini-Mental State Examination score > 24
Exclusion Criteria:
- History of surgery of affected lower limb
- Fracture of affected lower limb
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：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：Robot-assisted gait training
experimental group that applied the end-effector robot-assisted gait training
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intervention with robot-assisted gait training
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有源比较器：Treadmill gait training
control group that applied the treadmill gait training
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intervention with treadmill gait training
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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 |
|---|---|---|
|
oxygenated hemoglobin levels
大体时间：4 weeks from baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
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4 weeks from baseline
|
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Range of motion of ankle, knee, and hip joint
大体时间：4 weeks from baseline
|
ankle, knee, and hip joint motion of sagittal plane during gait
|
4 weeks from baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
oxygenated hemoglobin levels
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Range of motion of ankle, knee, and hip joint
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
ankle, knee, and hip joint motion of sagittal plane during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Berg Balance Scale
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life.
Each task is scored on a five-point scale (0-4) following the guidelines of the test developers, and the maximum score on this test is 56 which indicates balance ability within the normal range.
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Fugl-Meyer Assessment
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity.
It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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10m walk test
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Functional ambulation category
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Falls efficacy scale
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Beck depression inventory
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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21-question multiple-choice self-report inventory, one of the most widely used psychometric tests
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Stroke impact scale
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
health-related quality of life poststroke across 8 domains using a 5-point Likert scale, with the score ranging from 0 to 100 and a higher score indicating better health status
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Dynamic gait index
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
a clinical tool to assess gait, balance and fall risk
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Timed up and go test
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
a simple test used to assess a person's mobility and requires both static and dynamic balance
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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modified Barthel index
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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dual task - COWAT
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Controlled Oral Word Association Test, abbreviated COWA or COWAT, is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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dual task - digit span test
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
The digit span test is a way of measuring the storage capacity of a person's working memory.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Electromyography of lower extremities
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.
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baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Plantar pressure
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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Spatiotemporal gait parameter data
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
step length, step time, swing time, double limb support time during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
deoxygenated hemoglobin levels
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
total hemoglobin levels
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Balance test using force plate
大体时间：baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
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。
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 (实际的)
2018年9月1日
初级完成 (实际的)
2019年11月30日
研究完成 (实际的)
2019年12月31日
研究注册日期
首次提交
2019年8月12日
首先提交符合 QC 标准的
2019年8月12日
首次发布 (实际的)
2019年8月13日
研究记录更新
最后更新发布 (实际的)
2020年2月11日
上次提交的符合 QC 标准的更新
2020年2月9日
最后验证
2020年2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.