UMIN-CTR Clinical Trial

Public title

A comparative study on the effect of voice training on oral and pharyngeal functions imploying videofluoroscopy.

Acronym

A comparative study on the effect of voice training on oral and pharyngeal functions imploying videofluoroscopy.

Scientific Title

A comparative study on the effect of voice training on oral and pharyngeal functions imploying videofluoroscopy.

Scientific Title:Acronym

A comparative study on the effect of voice training on oral and pharyngeal functions imploying videofluoroscopy.

Region

Japan

Condition

Dysphagia

Classification by specialty

Geriatrics

Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to clarify the effectiveness of voical training as a training method to improve oral and pharyngeal function. We would like to compare it with conventional training and report its usefulness.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Videofluoroscopic swallowing study

Assessments will be performed before and after the training period, and these results will be compared statistically.
The training period will be a maximum of 3 months. If any videofluoroscopic swallowing study are performed as part of medical examination during the training period,
this will also be included in the analysis.

Key secondary outcomes

Basic information (age, sex, medical history, height, weight, occupation)
Oral function test (tongue pressure, opening strength, hardness of palatopharyngeal muscles)
Swallowing function survey using the swallowing screening questionnaire (EAT-10)
Ultrasonography (length, thickness, and brightness of perioral muscles)
Results of swallowing angiography analysis
Oral diadochokinesis
Longest possible vocalization duration
Repeated saliva swallowing test
Tongue pressure
Highest possible tone
Masticatory ability

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Voical training comprised of whole body exercises, singing scales and singing 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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

30 patients who visited the Tokyo Medical and Dental University Hospital (mainly the outpatient clinic of Dysphagia rehabilitation and Maxillofacial Prosthetics) and those who gave their consent to participate in the study.

Key exclusion criteria

(1) Patients who have a progressive disease that causes dysphagia.
(2) Those with impaired consciousness, dementia, or other conditions that make it difficult to follow instructions.
(3) Those who are in a nursing home (public or private facilities excluding residential facilities) or is hospitalized.
Patients who meet any of the above conditions (1) to (3) will be excluded from the study.

Target sample size

30

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

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

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

09

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2021

Year

09

Month

09

Day

Date of IRB

Anticipated trial start date

2021

Year

11

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

09

Month

09

Day

Last modified on

2023

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051876