UMIN-CTR Clinical Trial

Basic information
Public title	Research on motor and auditory functions when playing musical instruments
Acronym	Exercise effect of playing a musical instrument
Scientific Title	Research on motor and auditory functions when playing musical instruments
Scientific Title:Acronym	Exercise effect of playing a musical instrument
Region	Japan

Condition
Condition	Upper limb motor paralysis
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of effectiveness for improving finger movement in patients with upper limb paralysis by keyboard instrument performance training rehabilitation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Surface Electromyography (sEMG) and MIDI signal during keyboard instrument performance before and after rehabilitation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Continuous training of playing with keyboard instruments
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Music therapy will be given to 16 inpatients in the convalescent ward under the guidance of a doctor with the cooperation of the hospital. These subjects present with upper limb motor paralysis due to sequelae of cerebrovascular accidents, and are considered to be able to understand verbal instructions. (2) Regarding the piano keyboard operation experiment, the experiment will be conducted on 16 inpatients of our hospital and 30 students of Toyohashi University of Technology. Gender and age do not matter. Those who have not received special music training other than school education in the past, and those who have no hearing problems.
Key exclusion criteria	Those who do not understand the language instructions. Those who have received special music training other than school education in the past.
Target sample size	62

Research contact person
Name of lead principal investigator	1st name Toshie Middle name Last name Matsui
Organization	Toyohashi University of Technology
Division name	Department of Computer Science and Engineering
Zip code	441-8580
Address	1-1 Hibarigaoka, Tempaku-cho, Toyohashi, Aichi
TEL	0532-44-6890
Email	tmatsui@cs.tut.ac.jp

Public contact
Name of contact person	1st name Toshie Middle name Last name Matsui
Organization	Toyohashi University of Technology
Division name	Department of Computer Science and Engineering
Zip code	441-8580
Address	1-1 Hibarigaoka, Tempaku-cho, Toyohashi, Aichi
TEL	0532-44-6890
Homepage URL
Email	tmatsui@cs.tut.ac.jp

Sponsor
Institute	Toyohashi University of Technology
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toyohashi University of Technology Research Ethics Review Board for Humans
Address	1-1 Hibarigaoka, Tempaku-cho, Toyohashi, Aichi, 441-8580
Tel	0532-44-6982
Email	kensien@office.tut.ac.jp

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	2022 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	19
Results
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	2019 Year 07 Month 31 Day
Date of IRB	2019 Year 09 Month 12 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 08 Day
Last modified on	2022 Year 03 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053749