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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04005313
Other study ID # IRB105-116-A
Secondary ID 107-2218-E-320 -
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date July 2019

Study information

Verified date July 2019
Source Buddhist Tzu Chi General Hospital
Contact Kwan-Hwa Lin, PhD
Phone 0385653012499
Email khlin03@mail.tcu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 95 Years
Eligibility Inclusion Criteria:

- mild to moderate Dementia

- age-matched healthy subjects

Exclusion Criteria:

- can not follow order

Study Design


Related Conditions & MeSH terms


Intervention

Device:
vibroacoustic device
the participants will receive the vibroacustic device or music therapy

Locations

Country Name City State
Taiwan Kwan-Hwa Lin Hualien City

Sponsors (1)

Lead Sponsor Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Beinert K, Englert V, Taube W. After-effects of neck muscle vibration on sensorimotor function and pain in neck pain patients and healthy controls - a case-control study. Disabil Rehabil. 2019 Aug;41(16):1906-1913. doi: 10.1080/09638288.2018.1451925. Epub 2018 Mar 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. . 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. one year
Secondary The pressure pain threshold following multisensory stimulation will be assessed around cervical region. The pressure pain threshold was measured by MicroFET3 ( Hoggan Health Industries, Utah, USA) at cervical region including cervical erector (CE), upper trapezius (UT) and sternocleidomastoid (SCM). At the trigger point of the muscle, the pressure of the test group is increased at a rate of about 1 newton/second. When the subject feels uncomfortable, the active stop is the end point of the test for perceived pain threshold. one year
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