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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045954
Receipt No. 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

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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
Email 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
Email harukatohara@hotmail.com

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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