UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022127
Receipt number R000025507
Scientific Title Verification of the effect of passive listening of music at home for severe Parkinson's disease patient is given to the motor function and mental function
Date of disclosure of the study information 2016/05/12
Last modified on 2018/03/07 14:06:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Verification of the effect of passive listening of music at home for severe Parkinson's disease patient is given to the motor function and mental function

Acronym

Verification of music therapy effect against severe Parkinson's disease patients

Scientific Title

Verification of the effect of passive listening of music at home for severe Parkinson's disease patient is given to the motor function and mental function

Scientific Title:Acronym

Verification of music therapy effect against severe Parkinson's disease patients

Region

Japan


Condition

Condition

Parkinson's disease

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of music therapy effect against severe Parkinson's disease patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Finger tap test ( Intervention before , after 4 weeks )

Key secondary outcomes

The activity amount ( Intervention before , after 4 weeks )
self rating depression scale ( Intervention before , after 4 weeks )


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Music listening
Period of intervention:4weeks
Intervention frequency:1h/day

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Hoehn-Yahr Stage:4-5

Key exclusion criteria

Motor dysfunction other than Parkinson's disease
Hearing loss

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoichi Ohno

Organization

Takasaki University of Health and Welfare

Division name

Department of Physical therapy, Faculty of Health care

Zip code


Address

501 Nakaoruicho, Takasaki City, Gunma, JAPAN

TEL

027-352-1291

Email

ohno@takasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Kuwabara

Organization

Takasaki University of Health and Welfare

Division name

Department of Nursing, Faculty of Health care

Zip code


Address

501 Nakaoruicho, Takasaki City, Gunma, JAPAN

TEL

027-352-1291

Homepage URL


Email

kuwabara@takasaki-u.ac.jp


Sponsor or person

Institute

Takasaki University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

The Yuumi Memorial Foundation for Home Health Care

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Due to the auditory effect the mental function, daily activity amount, motor function were improved.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 04 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 12 Day

Last follow-up date

2017 Year 08 Month 01 Day

Date of closure to data entry

2017 Year 08 Month 01 Day

Date trial data considered complete

2017 Year 08 Month 01 Day

Date analysis concluded

2017 Year 08 Month 01 Day


Other

Other related information

An interim report is published in Journal of Japan Academy of Home Care 2018; 5 (1).


Management information

Registered date

2016 Year 04 Month 28 Day

Last modified on

2018 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025507


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name