Robot-assisted Gait Training for Patients With Stroke
2016年7月26日 更新者:China Medical University Hospital
Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors.
It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.
研究概览
详细说明
Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability.
Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program.
However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear.
It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.
研究类型
介入性
注册 (预期的)
60
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:Nai-Hsin Meng, M.D.
- 电话号码:2381 886-4-22052121
- 邮箱:nsmeng@ms13.hinet.net
学习地点
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Taichung City、台湾、404
- 招聘中
- China Medical University Hospial
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首席研究员:
- Nai-Hsin Meng, M.D.
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接触:
- Nai-Hsin Meng, M.D.
- 电话号码:2381 886-4-22052121
- 邮箱:nsmeng@ms13.hinet.net
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副研究员:
- Li-Wei Chou, M.D. Ph.D.
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副研究员:
- Pei-Yu Yang, M.D.
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副研究员:
- Andy Chien, Ph.D.
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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
20年 至 65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:
- Between the age of 20-65 years;
- Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
- Paresis of a lower limb;
- Inability to walk without aid or device.
Exclusion Criteria:
- Deemed by a physician to be medically unstable;
- Other prior musculoskeletal conditions that affected gait capacity;
- Co-existence of other neurological diseases;
- Cognitive impairments that would impact on the safe participation in the study (MMSE<23) -
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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有源比较器:Standard Rehabilitation
Patient with stroke receiving standard hospital based rehabilitation program
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Standard hospital based rehabilitation for patients with stroke
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实验性的:Robot-assisted Rehabilitation
Patient with stroke receiving standard hospital based rehabilitation as well as robot-assisted gait rehabilitation program
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An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke
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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 |
---|---|---|
Fugl-Meyer Assessment, lower extremity subscale
大体时间:Assessing change from baseline after 1 month of intervention
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Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale
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Assessing change from baseline after 1 month of intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Functional Ambulation Categories
大体时间:Assessing change from baseline after 1 month of intervention
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Categorizes patients according to basic motor skills necessary for functional ambulation
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Assessing change from baseline after 1 month of intervention
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10 Meters Walking Test
大体时间:Assessing change from baseline after 1 month of intervention
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Assesses walking speed in meters per second over a short duration
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Assessing change from baseline after 1 month of intervention
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Berg Balance Scale
大体时间:Assessing change from baseline after 1 month of intervention
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testing a participant's static and dynamic balance abilities
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Assessing change from baseline after 1 month of intervention
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Timed Up and Go test
大体时间:Assessing change from baseline after 1 month of intervention
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Assess a participant's mobility and requires both static and dynamic balance
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Assessing change from baseline after 1 month of intervention
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Kinetic and Kinematic Gait Analysis
大体时间:Assessing change from baseline after 1 month of intervention
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The temporo-spatial and kinematic gait parameters of the participants will be assessed using a Vicon Motion Analysis System with kinetic data collection through a force plate.
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Assessing change from baseline after 1 month of intervention
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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:Nai-Hsin Meng, M.D.、China Medical University, China Medical University Hospital
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
2016年5月1日
初级完成 (预期的)
2018年6月1日
研究完成 (预期的)
2018年12月1日
研究注册日期
首次提交
2016年5月3日
首先提交符合 QC 标准的
2016年5月20日
首次发布 (估计)
2016年5月25日
研究记录更新
最后更新发布 (估计)
2016年7月27日
上次提交的符合 QC 标准的更新
2016年7月26日
最后验证
2016年7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.
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