UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045954 |
|---|---|
| Receipt number | R000052451 |
| Scientific Title | A before-after study on feeding and swallowing rehabilitation through vocal training |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2021/11/01 21:39:06 |
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Basic information
Public title
A before-after study on feeding and swallowing rehabilitation through vocal training
Acronym
A before-after study on feeding and swallowing rehabilitation through vocal training
Scientific Title
A before-after study on feeding and swallowing rehabilitation through vocal training
Scientific Title:Acronym
A before-after study on feeding and swallowing rehabilitation through vocal training
Region
| Japan |
Condition
Condition
Dysphagia, Oral Cancer
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effectiveness of vocal training on oral, respiratory and swallowing functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tongue Pressure
RSST
Oral diadochokinesis
EAT-10
Ultrasound imaging (Perioral muscles)
Masticatory function
Key secondary outcomes
MPT
Highest note achieved during singing
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Voice training that consists of (i) exercises of the whole body including the oral cavity and (ii) singing scales and songs.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult volunteers who have given written consent to participate in this study.
Key exclusion criteria
(1) Patients who have a disease that causes dysphagia, and the disease is poorly controlled or in the acute stage.
(2) Patients who have a disease that causes dysphagia and whose disease is progressive.
(2) Patients who have a disease that causes dysphagia, where that disease is a progressive disease.
(3) Patients with disorders of consciousness or dementia who have difficulty following instructions.
(4) Those who are hospitalized.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Dysphagia rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8549, JAPAN
TEL
81-3-5803-5559
harukatohara@hotmail.com
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Tohara |
Organization
Tokyo Medical and Dental University
Division name
Dysphagia rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical an
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8549, JAPAN
TEL
81-3-5803-5559
Homepage URL
harukatohara@hotmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical and Dental University, Dental Hospital
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8549, JAPAN
Tel
81-3-5803-5559
d-hyoka.adm@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
| 2021 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 11 | Month | 01 | Day |
Last modified on
| 2021 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052451
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
