Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
2021年4月5日 更新者：Aline de Souza Pagnussat、Federal University of Health Science of Porto Alegre
The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.
研究概览
详细说明
This is a feasibility study that aims to investigate the safety and efficacy of dance classes via an online platform in people with and without Parkinson's Disease.
The intervention will last 2 months and the classes will be conducted twice a week (60 minutes) using the Zoom platform.
Evaluations will be performed before and after the intervention by means of the Zoom platform as well and will include questionnaires of quality of life, depression, anxiety, and activities of daily living.
研究类型
介入性
注册 (实际的)
24
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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Rio Grande Do Sul
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Porto Alegre、Rio Grande Do Sul、巴西、90050-170
- Universidade Federal de Ciências da Saúde de Porto Alegre
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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 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:
- Individuals with and without parkinson's disease according London Brain Bank Criteria
- Minimal cognitive ability to understand commands (MMSE)
- Able to stand at least 10 minutes with or without support
- Dopamine medication stable at least 6 weeks before the beginning of the study
- Portable device and internet connection
Exclusion Criteria:
- Severe visual or auditive disturbances
- Neurological disease (other than parkinson's for those included) or severe neuromuscular disorders that prejudice the proposed activities
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：telerehabilitation with dance (Parkinson's)
This group will receive dance classes online during 60 minutes, twice a week for 8 weeks.
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Dance classes will be provided through a online platform.
Each class will last 60 minutes, twice a week, during 8 weeks.
|
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有源比较器：telerehabilitation with dance (Healthy controls)
This group will receive dance classes online during 60 minutes, twice a week for 8 weeks.
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Dance classes will be provided through a online platform.
Each class will last 60 minutes, twice a week, during 8 weeks.
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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 |
|---|---|---|
|
feasibility (adherence rates)
大体时间：10 weeks
|
To assess the feasibility of the study design and procedures.
The adherence rate will be calculated by the total number of patients who completed the full course of intervention divided by the total number of patients included at the beginning.
|
10 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
feasibility (patients opinions)
大体时间：10 weeks
|
Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of the intervention
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10 weeks
|
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feasibility (safety and usability)
大体时间：10 weeks
|
The researches will follow all patients during the intervention regarding safety (i.e.
falls) and usability (i.e.
internet connection)
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10 weeks
|
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Parkinson's Disease Questionnaire-8 (PDQ-8)
大体时间：Change from Pre to Post treatment (10 weeks)
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The PDQ-8 is a short-form version to assess quality of life in persons with Parkinson's disease.
Each question is scored from 0-4 points and the scores are summed and given as a percentage score (0-100).
The higher the score, the worse the patient's condition.
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Change from Pre to Post treatment (10 weeks)
|
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36-Item Short Form Survey (SF-36)
大体时间：Change from Pre to Post treatment (10 weeks)
|
The SF-36 measures health-related quality of life.
This questionnaire has 36-item measure divided into 8 subscales - each subscale can be used independently.
Each of the 8 summed scores is transformed into a scale from 0 (negative health) to 100 (positive health)
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Change from Pre to Post treatment (10 weeks)
|
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Hospital Anxiety and Depression Scale (HADS)
大体时间：Change from Pre to Post treatment (10 weeks)
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The scale is used to identify depression and anxiety and presents 14 items.
The total score is out of 42.
The higher scores indicate greater levels of anxiety and depression.
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Change from Pre to Post treatment (10 weeks)
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Unified Parkinson's Disease Rating Scale (UPDRS) Part I
大体时间：Change from Pre to Post treatment (10 weeks)
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The Part I concerns about non-motor experiences of daily living (e.g.
anxiety and depression).
This scale has 13 questions and all items have 5 response options.
Higher scores indicate greater impact of PD symptoms.
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Change from Pre to Post treatment (10 weeks)
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Activities-Specific Balance (ABC) Scale
大体时间：Change from Pre to Post treatment (10 weeks)
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Self-reported questionnaire measuring self-efficacy in performing activities without losing balance.
The ABC Scale consists of 16 questions that require the patient to rate their confidence on a scale from 0% to 100%.
The higher the percentage, the higher level of physical functioning.
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Change from Pre to Post treatment (10 weeks)
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Five Times Sit to Stand Test (FTSTS)
大体时间：Change from Pre to Post treatment (10 weeks)
|
The test assess the functional mobility strength of lower extremity (measured by the time to complete the test).
The higher the time to complete the test, the lower the performance.
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Change from Pre to Post treatment (10 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 (实际的)
2020年9月5日
初级完成 (实际的)
2020年10月5日
研究完成 (实际的)
2020年12月5日
研究注册日期
首次提交
2020年10月1日
首先提交符合 QC 标准的
2020年10月7日
首次发布 (实际的)
2020年10月9日
研究记录更新
最后更新发布 (实际的)
2021年4月6日
上次提交的符合 QC 标准的更新
2021年4月5日
最后验证
2021年4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.