UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020093 |
|---|---|
| Receipt number | R000023178 |
| Scientific Title | Evaluation of the posterior tongue muscle activity at the time of chewing and swallowing using the neck surface EMG |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2015/12/17 10:51:04 |
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Basic information
Public title
Evaluation of the posterior tongue muscle activity at the time of chewing and swallowing using the neck surface EMG
Acronym
Evaluation of the posterior tongue muscle activity at the time of chewing and swallowing using the neck surface EMG
Scientific Title
Evaluation of the posterior tongue muscle activity at the time of chewing and swallowing using the neck surface EMG
Scientific Title:Acronym
Evaluation of the posterior tongue muscle activity at the time of chewing and swallowing using the neck surface EMG
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate posterior tongue muscle activity at the time of chewing and swallowing two kinds of different food of the property using few invasive neck surface EMG.
Basic objectives2
Others
Basic objectives -Others
Difference in posterior tongue muscle activity aspect by the food property
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Posterior tongue muscle active mass at the time of the intervention
Key secondary outcomes
Timing of the muscle activity outbreak, 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
Chewing, swallowing the following food at the time of EMG recording.
1)half piece of cookie
2)crushed cookie of the same amount and mixed with distilled water and artificial saliva
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
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult who without oral function abnormality
Key exclusion criteria
When a subjects corresponds to any of the following items, he/she is excluded from this study;
1)There is awareness of dysphagia
2)There is the past of temporomandibular disorder
3)Allergy to alcohol antiseptic solution
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Minagi |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6687
minagi@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Maeda |
Organization
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name
Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-6687
Homepage URL
naoto-m-10@t.okadai.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 12 | Month | 07 | 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
| 2015 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2015 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023178
| 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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