UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049443 |
|---|---|
| Receipt number | R000056289 |
| Scientific Title | The influence of a comprehensive examination of experience eating and swallowing function on high school students -The perception and interest of the elderly in extending healthy life expectancy and speech-language hearing therapist- |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2022/11/07 10:55:45 |
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Basic information
Public title
The influence of a comprehensive examination of experience eating and swallowing function on high school students
-The perception and interest of the elderly in extending healthy life expectancy and speech-language hearing therapist-
Acronym
The influence of a comprehensive examination of experience eating and swallowing function on high school students
-The perception and interest of the elderly in extending healthy life expectancy and speech-language hearing therapist-
Scientific Title
The influence of a comprehensive examination of experience eating and swallowing function on high school students
-The perception and interest of the elderly in extending healthy life expectancy and speech-language hearing therapist-
Scientific Title:Acronym
The influence of a comprehensive examination of experience eating and swallowing function on high school students
-The perception and interest of the elderly in extending healthy life expectancy and speech-language hearing therapist-
Region
| Japan |
Condition
Condition
high school students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of an explanation of the current situation of the elderly and the role of speech-language hearing therapist to high school students and their experience with a comprehensive examination of eating and swallowing function on high school students' perceptions and interest in extending the healthy life expectancy of the elderly and in speech-language hearing therapist.
Basic objectives2
Others
Basic objectives -Others
To investigate the impact of an explanation of the current situation of the elderly and the role of speech-language hearing therapist to high school students and their experience with a comprehensive examination of eating and swallowing function on high school students' perceptions and interest in extending the healthy life expectancy of the elderly and in speech-language hearing therapist.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conduct a comprehensive examination experience on eating and swallowing function followed by a questionnaire survey.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
explanation of the current situation of the elderly and the role of speech-language hearing therapists
Lecture will be given using PowerPoint slides, etc.
Comprehensive examination of eating and swallowing function
Eating and Swallowing Function:
EAT-10
Water swallowing test
Repeated saliva swallowing test
Muscle mass of swallowing-related muscles
Ultrasound echo
Strength of swallowing-related muscles
Maximum tongue pressure
Maximal expiratory intraoral pressure
Oral cavity function
Tongue and lip motor function
Bite strength
Oral dryness
Oral hygiene
Masticatory ability test
Discussion among high school students
Questionnaire survey
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Forty cases who agree with the purpose of the study will be included. The necessity and methods of the study will be explained and consent will be obtained.
Key exclusion criteria
High school students who did not consent to the study are excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KEIGO |
| Middle name | |
| Last name | MATSUBARA |
Organization
Kumamoto Health Science University
Division name
Division of Speech-Language-Hearing Therapy, Department of Rehabilitation, Faculty of Health Science
Zip code
8615598
Address
325 Izumi machi, kitaku, kumamoto
TEL
0962752111
matubara-ke@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | KEIGO |
| Middle name | |
| Last name | MATSUBARA |
Organization
Kumamoto Health Science University
Division name
Division of Speech-Language-Hearing Therapy, Department of Rehabilitation, Faculty of Health Science
Zip code
861-5598
Address
325 Izumi machi, kitaku, kumamoto
TEL
096-275-2146
Homepage URL
matubara-ke@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science 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
Kumamoto Health Science University
Address
325 Izumi machi, kitaku, kumamoto
Tel
0962752111
matubara-ke@kumamoto-hsu.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
| 2023 | Year | 08 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056289
| Research Plan | |
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| 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 |
