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临床试验/NCT04005313
NCT04005313Unknown不适用

Development and Application of Portable Multisensory Stimulation Device: Vibroacustic Therapy

Buddhist Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
the electroencephalographic (EEG) activities ncluding Alpha, Beta, Theta, and Delta signals will be assessed in persons with mild to moderate dementia and healthy subjects.after sensory stimulation. .

研究概览

简要总结

This is a study to develop the vibroacustic devices, and to compare the effects between vibroacustic device therapy and music therapy in adults with dementia or with neck pain. The immediate effect and long-term training effect would be assessed.

详细描述

The outcome measures included functional assessment ( such as: range of motion, balance etc.) and neurolphysiological assessment (such as: electroencephalographic activity or electromyographic activity).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •mild to moderate Dementia
  • •age-matched healthy subjects

排除标准

  • •can not follow order

研究组 & 干预措施

Comparison between unisensory and multisensory stimulation

Experimental

The same person receive unisensory and multisensory stimulation on separate day.

干预措施: vibroacoustic device (Device)

The treatment effect of multisensory stimulation

Experimental

The persons living in long-term care facility would receive multisensory stimulation for one month.

干预措施: vibroacoustic device (Device)

Multisensory stimulation and virtual reality.

Experimental

The subjects would receive vibroacoustic therapy or virtual reality.

干预措施: vibroacoustic device (Device)

Vibroacustic therapy on neck pain.

Experimental

The subjects would receive either vibroacustic therapy or music therapy.

干预措施: vibroacoustic device (Device)

结局指标

主要结局

the electroencephalographic (EEG) activities ncluding Alpha, Beta, Theta, and Delta signals will be assessed in persons with mild to moderate dementia and healthy subjects.after sensory stimulation. .

时间窗: one year

The EEG was recorded by EMOTIV EPOC+ mobile headset (Bioinformatics Company, USA). The wireless 14-EEG channels on the skull were located at anterior frontal (AF), frontal (F), frontal central (FC), temporal (T), parietal (P) and occipital (O) areas,The frequency analysis of brain waves includinh Alpha, Beta, Theta, and Delta signals before, during and after sensory stimulation will be recorded and analyzed.

次要结局

  • The pressure pain threshold following multisensory stimulation will be assessed around cervical region.(one year)

研究者

发起方
Buddhist Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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