UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045435 |
|---|---|
| Receipt number | R000051876 |
| Scientific Title | A comparative study on the effect of voice training on oral and pharyngeal functions imploying videofluoroscopy. |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2023/05/31 16:13:37 |
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Basic information
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
Condition
Dysphagia
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Assessment
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
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
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
Eligibility
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
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
Self funding
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 | 09 | Month | 10 | 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 | 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
Other related information
Management 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
