用于认知护理的手部训练装置
2024年5月23日 更新者：Fong Chin Su、National Cheng-Kung University Hospital
先前的研究表明，听觉刺激作为外部提示可能对感觉运动同步产生积极影响。
此外，根据之前的报道，除了传统的干预措施外，基于游戏的数字化设备，例如 FTOMBVG，也有利于老年人的大脑激活。
[27]。
此外，增强的手指力量控制和协调性可以提高手的灵活性，并被认为最终可以改善健康老年人和认知能力下降的老年人的生活独立性。
因此，本研究旨在在前一系统的基础上开发一种先进的系统，可以为老年人或患有认知缺陷的人提供手功能康复、认知训练和情绪安慰。
他们可以通过游戏过程中嵌入的音乐来增强手指力量控制或视觉与运动同步。
研究概览
研究类型
介入性
注册 (实际的)
80
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
-
-
-
Tainan、台湾、701
- National Cheng Kung University
-
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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
- 年长者
接受健康志愿者
是的
描述
纳入标准：
- 能够用普通话或台语沟通
- MCI，根据临床神经学评估，蒙特利尔认知评估（MoCA）：≤25&≧19
- 能够独立进行ADL，无手部功能障碍
- 自愿参与并有能力签署知情同意书
排除标准：
- 经医生诊断为阿尔茨海默病或符合痴呆症诊断标准
- 医生诊断中风
- 任何精神疾病或行为问题且无法配合培训师
- 视力障碍或手部疾病导致无法进行手指按压
- 在过去一年中接受过其他认知或身体训练
- 任何视力、听力或沟通障碍
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：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：基于音乐的游戏训练
受试者将被要求按下手指，一系列射箭靶随着Tipr上的音乐旋律不断下降并越过底线。
|
该软件与 Frets on Fire (FOF) 的修改版本相连接，这是一款类似于《吉他英雄》的开源电脑游戏。
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有源比较器：非音乐游戏训练
背景音乐将被禁用。
受试者需要在一定的容差范围内按下等量的力，该容差仅由 Tipr 上的视觉提示设置。
|
该软件与 Frets on Fire (FOF) 的修改版本相连接，这是一款类似于《吉他英雄》的开源电脑游戏。
|
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 |
|---|---|---|
|
氧合血红蛋白 (HbO)
大体时间：30分钟
|
参与者在两种条件下玩游戏时测量了氧合血红蛋白 (HbO)
|
30分钟
|
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蒙特利尔认知评估（MoCA）测试
大体时间：10分钟
|
蒙特利尔认知评估 (MoCA) 旨在作为轻度认知功能障碍的快速筛查工具。
它评估不同的认知领域：短期记忆、视觉空间能力、执行功能、注意力、专注力和工作记忆、语言、时间和地点定向。
MoCA 检测 MCI 的灵敏度为 90%。
|
10分钟
|
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EN值
大体时间：5分钟
|
力独立性是在每个评估会话的力控制游戏期间从数据中收集的。
力独立性参数是一个五位数字的整体奴役指数，表示为EN。
|
5分钟
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
最大自主等长收缩（MVIC）
大体时间：10秒
|
测量每个手指的最大自主等长收缩，以供训练参考。
|
10秒
|
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：Fong-Chin Su, PhD、Chair Professor
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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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)
2022年3月27日
初级完成 (实际的)
2022年4月11日
研究完成 (实际的)
2022年4月11日
研究注册日期
首次提交
2024年5月12日
首先提交符合 QC 标准的
2024年5月12日
首次发布 (实际的)
2024年5月16日
研究记录更新
最后更新发布 (实际的)
2024年5月28日
上次提交的符合 QC 标准的更新
2024年5月23日
最后验证
2024年5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.
游戏软件的临床试验
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Université Blaise Pascal, Clermont-Ferrand撤销