UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yoichi Ohno
Organization	Takasaki University of Health and Welfare
Division name	Department of Physical therapy, Faculty of Health care
Address	501 Nakaoruicho, Takasaki City, Gunma, JAPAN
TEL	027-352-1291
Email	ohno@takasaki-u.ac.jp

Public contact
Name of contact person	Atsushi Kuwabara
Organization	Takasaki University of Health and Welfare
Division name	Department of Nursing, Faculty of Health care
Address	501 Nakaoruicho, Takasaki City, Gunma, JAPAN
TEL	027-352-1291
Homepage URL
Email	kuwabara@takasaki-u.ac.jp

Sponsor
Institute	Takasaki University of Health and Welfare
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Due to the auditory effect the mental function, daily activity amount, motor function were improved.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025507