Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for PD
2020年8月22日 更新者：Bomin Sun、Ruijin Hospital
Yi Jin Jing Tiger Roaring Speech Rehabilitation With Real-Time Feedback Technique for Treatment of Speech Disorders in Parkinson's Disease: A Perspective Cohort Study
Speech disorders affect more than 90% of patients with Parkinson's disease (PD).
Neither of conventional drugs nor surgery can effectively improve speech function.
Western speech rehabilitation is effective for speech disorders, but the domestic use of those methods used is limited.
Our preliminary results revealed that traditional Chinese Yi jin jing tiger roaring speech rehabilitation is effectively in the treatment of speech disorders in PD, however, high-quality clinical evidence is still scarce.
In order to solve this problem, we will conduct a prospective cohort study to explore the effects of Yi Jin Jing tiger roaring speech rehabilitation with real-time feedback technique on speech disorders in PD patients.
This study will help to establish a set of Chinese Medicine treatment and objective evaluation methods for PD speech disorders.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (预期的)
20
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：Dianyou Li, MD, PhD
- 电话号码：+8613817864569
- 邮箱：ldy11483@rjh.com.cn
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200025
- Functional neurosurgery of Shanghai Jiaotong University affiliated Ruijin Hospital
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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
45年 至 75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:
- Patients with idiopathic Parkinson's disease
- Native language is Chinese
- VHI-10 score more than 10
- informed consent
Exclusion Criteria:
- Previous or concurrent medical history affecting swallowing function (laryngeal diseases such as vocal nodules, gastroesophageal reflux, and laryngeal cancer).
- History of serious psychosis
- Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
- Dementia (A Mini-Mental State Examination (MMSE) score of < 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
- Lack of cooperation
- Additional reasons for exclusion at the discretion of the clinical investigator
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：非随机化
- 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：Yi Jin Jing Tiger Roaring Speech Rehabilitation
Yi Jin Jing tiger roaring speech rehabilitation with real-time feedback technique Duration: Each time requires an hour of training; Frequency: three times a week, 4 weeks in total.
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A traditional Chinese medicine treatment
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实验性的：Conventional Speech Rehabilitation
Patients will receive speech rehabilitation recommended by The Parkinson's Foundation. Duration: Each time requires an hour of training; Frequency: three times a week, 4 weeks in total. |
A active speech rehabilitation method recommended by the Parkinson's Foundation of America
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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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Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states
大体时间：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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The Voice Handicap Index is a self-administered instrument, comprising 30 items on voice-related dysfunction.
VHI has a range of 0 (normal voice function) to 120 (severe voice dysfunction).
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Differences in voice parameters between treatment conditions in the on- and off- medication states
大体时间：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Voice recording at a sampling rate of 44.1 kHz using 16-bit quantification will be conducted in a sound-treated room using a microphone and a digital voice recorder with a mouth-to-microphone distance of 15 cm.
The recorded voices will then be used for a composit acoustic analysis.
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
大体时间：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
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Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.
大体时间：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
|
Burg Balance Scale measures patients' static and dynamic balance abilities.
BBS score has a range of 0 (severe balance problems) to 56 (no balance problems).
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.
大体时间：Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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The Water Swallow Test is frequently used in clinical practice as a functional assessment to detect dysphagia, with stage 1 indicating severe dysphagia and stage 6 indicating normal swallowing function.
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Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
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Differences in Beck Depression Inventory (BDI) scores between Treatment conditions.
大体时间：Baseline, 4 weeks
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Beck Depression Inventory is a self-administered Instrument, contains 21 self-report items.
The items are scored as 0, 1, 2, or 3.
The score range is 0 (no depression) to 63 (severe depression).
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Baseline, 4 weeks
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Differences in Beck Anxiety Inventory (BAI) scores between treatment conditions.
大体时间：Baseline, 4 weeks
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The BAI is a rating scale used to evaluate the severity of anxiety symptoms.
It contains 21 self-report items.
The items are scored as 0, 1, 2, or 3.
The score range is 0-63.
A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.
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Baseline, 4 weeks
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Differences in 8-item Parkinson's Disease Questionnaire (PDQ-8) scores between treatment conditions.
大体时间：Baseline, 4 weeks
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8-item Parkinson's Disease Questionnaire is a 8-item health-related quality of life instrument for subjects with Parkinson's Disease, which has a score range of 0 (good life quality) to 32 (very bad life quality).
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Baseline, 4 weeks
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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。
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 (预期的)
2020年10月1日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2023年9月30日
研究注册日期
首次提交
2020年8月22日
首先提交符合 QC 标准的
2020年8月22日
首次发布 (实际的)
2020年8月27日
研究记录更新
最后更新发布 (实际的)
2020年8月27日
上次提交的符合 QC 标准的更新
2020年8月22日
最后验证
2020年8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.