UMIN-CTR Clinical Trial

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