UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047120 |
|---|---|
| Receipt number | R000053749 |
| Scientific Title | Research on motor and auditory functions when playing musical instruments |
| Date of disclosure of the study information | 2022/03/09 |
| Last modified on | 2022/03/08 22:09:28 |
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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
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
tmatsui@cs.tut.ac.jp
Sponsor or person
Institute
Toyohashi University of Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053749
