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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Taipei、台湾、100
- 募集
- National Taiwan University Hospital
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コンタクト：
- Ruey-Meei Wu, Professor
- 電話番号：2144 886-2-23123456
- メール：robinwu@ntu.edu.tw
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コンタクト：
- Wen-Chieh Yang, Ph.D. student
- 電話番号：886-2-33668149
- メール：d98428003@ntu.edu.tw
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主任研究者：
- Ruey-Meei Wu, Professor
-
主任研究者：
- Kwan-Hwa Lin, Professor
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Taipei、台湾、100
- まだ募集していません
- National Taiwan University Hospital
-
コンタクト：
- Ruey-Meei Wu, Professor
- 電話番号：2144 886-2-23123456
- メール：robinwu@ntu.edu.tw
-
コンタクト：
- Wen-Chieh Yang, Ph.D. student
- 電話番号：886-2-33668149
- メール：d98428003@ntu.edu.tw
-
主任研究者：
- Ruey-Meei Wu, Professor
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reliability of the somatosensory stimulation system
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Ruey-Meei Wu, Professor、Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
- 主任研究者：Kwan-Hwa Lin, Professor、Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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