UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037441 |
|---|---|
| Receipt number | R000042677 |
| Scientific Title | Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing in elderly people. |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2019/07/21 21:34:25 |
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Basic information
Public title
Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing in elderly people.
Acronym
Exploratory study on tongue pressure and the tongue base-lifting muscle activity in elderly people.
Scientific Title
Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing in elderly people.
Scientific Title:Acronym
Exploratory study on tongue pressure and the tongue base-lifting muscle activity in elderly people.
Region
| Japan |
Condition
Condition
dysphagia frailty
Classification by specialty
| Rehabilitation medicine | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between the muscle activity of the tongue base that occurs at the time of articulatory, mastication and swallowing in the elderly, evaluate swallowing function and masticatory function, and
Basic objectives2
Others
Basic objectives -Others
To compare and examine EMG data of elderly people and young people, and clarify the characteristics of elderly people.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle activity of tongue base-lifting activity at the time of the intervention
Key secondary outcomes
Onset and offset timing of the muscle activity, muscle activity continuation time at the time of the intervention
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Perform EMG recording under the following conditions.
1)articulation
2)chewing and swallowing.
Perform oral and swallowing function evaluation.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly people using removable dentures for unilateral free end space in either upper or lower jaw.
Key exclusion criteria
When a subjects corresponds to any of the following items, he/she is excluded from this study;
1)Allergy to alcohol antiseptic solution
2)Dysphagia
3)In addition, those judged to be inappropriate by the research director and the research sharing person as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | manda |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6687
y.manda@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yousuke |
| Middle name | |
| Last name | Manda |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6687
Homepage URL
y.manda@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6687
mae6605@adm.okayama-u.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
| 2019 | Year | 10 | 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
| 2019 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 07 | Month | 21 | Day |
Last modified on
| 2019 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042677
| 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 |
