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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028460
Receipt No. R000032526
Scientific Title Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing.
Date of disclosure of the study information 2017/10/01
Last modified on 2019/07/21

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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.
Acronym Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing.
Scientific Title Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing.
Scientific Title:Acronym Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing.
Region
Japan

Condition
Condition dysphagia frailty
Classification by specialty
Rehabilitation medicine Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measure the tongue pressure during articulation in healthy subjects and the muscle activity of the tongue base that occurs during articulation and examine the relationship between them.
Basic objectives2 Others
Basic objectives -Others Measure the muscle activity of the tongue base that occurs during chewing and swallowing in healthy subjects and examine the relationship between them.
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)when the tongue base is pressed against the palate.
3)chewing and swallowing.
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)Allergy to alcohol antiseptic solution
2)There is pronunciation impairment due to tooth defect and mucosal disease
3)In addition, those judged to be inappropriate by the research director and the research sharing person as subjects
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yousuke Manda
Organization Okayama university hospital
Division name Occlusal and Oral Functional Rehabilitation
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6687
Email y.manda@s.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yousuke manda
Organization Okayama university hospital
Division name Occlusal and Oral Functional Rehabilitation
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6687
Homepage URL
Email y.manda@s.okayama-u.ac.jp

Sponsor
Institute Okayama university
Institute
Department

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
Address
Tel
Email

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
2017 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 Completed
Date of protocol fixation
2017 Year 10 Month 17 Day
Date of IRB
2017 Year 10 Month 17 Day
Anticipated trial start date
2017 Year 10 Month 18 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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