Development and Application of Portable Multisensory Stimulation Device

NCT ID: NCT04005313

Last Updated: 2019-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Comparison between unisensory and multisensory stimulation

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

Group Type EXPERIMENTAL

vibroacoustic device

Intervention Type DEVICE

the participants will receive the vibroacustic device or music therapy

The treatment effect of multisensory stimulation

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

Group Type EXPERIMENTAL

vibroacoustic device

Intervention Type DEVICE

the participants will receive the vibroacustic device or music therapy

Multisensory stimulation and virtual reality.

The subjects would receive vibroacoustic therapy or virtual reality.

Group Type EXPERIMENTAL

vibroacoustic device

Intervention Type DEVICE

the participants will receive the vibroacustic device or music therapy

Vibroacustic therapy on neck pain.

The subjects would receive either vibroacustic therapy or music therapy.

Group Type EXPERIMENTAL

vibroacoustic device

Intervention Type DEVICE

the participants will receive the vibroacustic device or music therapy

Interventions

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vibroacoustic device

the participants will receive the vibroacustic device or music therapy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* mild to moderate Dementia
* age-matched healthy subjects

Exclusion Criteria

* can not follow order
Minimum Eligible Age

19 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chich-Haung Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Tzu Chi University

Locations

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Kwan-Hwa Lin

Hualien City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kwan-Hwa Lin, PhD

Role: CONTACT

0385653012499 ext. 2499

Facility Contacts

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Kwan-Hwa Lin, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29558836 (View on PubMed)

Other Identifiers

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107-2218-E-320 -001 -

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

106-2218-E-320 -001 -

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB107-39-B

Identifier Type: OTHER

Identifier Source: secondary_id

IRB105-116-A

Identifier Type: -

Identifier Source: org_study_id

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