UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046840 |
|---|---|
| Receipt number | R000053438 |
| Scientific Title | Effect of music exercise for oral function |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2025/02/12 09:29:45 |
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Basic information
Public title
Effect of music exercise for oral function
Acronym
Effect of music exercise for oral function
Scientific Title
Effect of music exercise for oral function
Scientific Title:Acronym
Effect of music exercise for oral function
Region
| Japan |
Condition
Condition
maxillofacial defect
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clearify the effect of music exercise to eating ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating ability before and after music exercise is evaluated using following tests.
1. Bite force
2. Oral diadochokinesis
3. Repetitive saliva swallowing test
4. Tongue pressure
5. Lip closure
6. Coughing test
7. Speech test
8. Nutritional Appetite
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
music exercise
Interventions/Control_2
pause
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
40 patients of maxillofacial prosthesis clinic in our university hospital, who agreed.
Key exclusion criteria
Those who can not have exercise because of dementia or hearing disability.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Sumita |
Organization
Tokyo Medical and Dental University
Division name
Maxillofacial Prosthetics
Zip code
113-8549
Address
Yushima 1-5-45
TEL
0358035556
yuka.mfp@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Sumita |
Organization
Tokyo Medical and Dental University
Division name
Maxillofacial Prosthetics
Zip code
113-8549
Address
Yushima 1-5-45, Bunyo-ku
TEL
0358035556
Homepage URL
yuka.mfp@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Mariko Hattori
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
Maxillofacial Prosthetics
Tel
0358035556
yuka.mfp@tmd.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 | 02 | Month | 28 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 09 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 08 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053438
