Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System
Freezing of Gait Correction and Fall Prevention in People With Parkinson's Disease: Developing and Application of a Real-time Somatosensory Stimulation System
Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in people with Parkinson's disease (PD), and closely associates with postural instability and fall. Previous studies had shown that somatosensory stimulation could induce weight shift, and this is probably helpful for gait reinitiation. Therefore, the investogators propose a two-year project to develop a wearable device, the somatosensory stimulation system (SSS), which monitors gait real-time and provide somatosensory stimulation once FOG episodes detected. And the investigators test the effects of this SSS device on FOG, fall, and walking function.
Methods: The first-year study is to build and validate this wearable SSS device. The customized device has sensor part and stimulator part; the former is an inertial sensor module to detect FOG episodes, and the latter is a microvibrator-embedded insole to facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are recruited and conduct FOG-provoking tasks during their medication "OFF" or "late On" state in a laboratory setting. The investigators test if the SSS device could facilitate lateral weight shift and help gait reinitiation, as well as the reliability. The second-year study is to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and randomly assign them into the experimental and control groups. Both groups wear the SSS device during the daytime for ten weeks, and the stimulator part is turned on during the first six weeks (intervention phase) only in the experimental group. The stimulator part is then kept off during the last four weeks (follow-up phase) in both groups. The effect of the SSS device is evaluated by the outcomes including FOG severity, fall and walking function, which are measured prior/after the intervention phase and after the follow-up phase.
Clinical relevance: This project tempts to combine real-time gait analysis with somatosensory-induced postural readjustment, and using this novel approach to improve FOG and fall in people with PD. The results of this projects might also provide an objective, long-term assessment tool to measure the FOG phenomenon for clinical and research fields.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ruey-Meei Wu, Professor
- 电话号码:2144 886-2-23123456
- 邮箱:robinwu@ntu.edu.tw
研究联系人备份
- 姓名:Wen-Chieh Yang, Ph.D. student
- 电话号码:886-2-33668149
- 邮箱:d98428003@ntu.edu.tw
学习地点
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Taipei、台湾、100
- 招聘中
- National Taiwan University Hospital
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接触:
- Ruey-Meei Wu, Professor
- 电话号码:2144 886-2-23123456
- 邮箱:robinwu@ntu.edu.tw
-
接触:
- Wen-Chieh Yang, Ph.D. student
- 电话号码:886-2-33668149
- 邮箱:d98428003@ntu.edu.tw
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首席研究员:
- Ruey-Meei Wu, Professor
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首席研究员:
- Kwan-Hwa Lin, Professor
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Taipei、台湾、100
- 尚未招聘
- National Taiwan University Hospital
-
接触:
- Ruey-Meei Wu, Professor
- 电话号码:2144 886-2-23123456
- 邮箱:robinwu@ntu.edu.tw
-
接触:
- Wen-Chieh Yang, Ph.D. student
- 电话号码:886-2-33668149
- 邮箱:d98428003@ntu.edu.tw
-
首席研究员:
- Ruey-Meei Wu, Professor
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Idiopathic Parkinsonian with Hoehn-Yahr score between 2 to 4
- Suffering freezing-of-gait in the recent week
- Able to walk unassisted over 30 meters in medication OFF period
Exclusion Criteria:
- Non-idiopathic Parkinsonian
- Comorbid with uncontrolled neurological, cardiovascular and orthopedic diseases that might affect balance and mobility
- Impaired cognitive function
- Abnormal plantar sensory function
- Abnormal coagulation function
学习计划
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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无干预:Without real-time somatosensory cue
Parkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes.
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实验性的:With real-time somatosensory cue
Parkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes.
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A novel sensory cue proposed in this study, which designed to facilitate weight shift during freezing-of-gait episodes.
This sensory cue is controlled by the real-time analysis of gait pattern, and given only when freezing-of-gait detected.
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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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Reliability of the somatosensory stimulation system
大体时间:2 weeks
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The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
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2 weeks
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Validity of the somatosensory stimulation system
大体时间:2 weeks
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If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
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2 weeks
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Fall prevention
大体时间:10 weeks
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If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.
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10 weeks
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合作者和调查者
调查人员
- 首席研究员:Ruey-Meei Wu, Professor、Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
- 首席研究员:Kwan-Hwa Lin, Professor、Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Real-time somatosensory cue的临床试验
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National Cancer Institute (NCI)招聘中