UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study on muscle fatigue assessment of tongue muscle by neck surface electromyography
Acronym	Muscle fatigue assessment of tongue muscle by neck surface electromyography
Scientific Title	Intervention study on muscle fatigue assessment of tongue muscle by neck surface electromyography
Scientific Title:Acronym	Muscle fatigue assessment of tongue muscle by neck surface electromyography
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate muscle fatigue of the tongue muscles by neck surface electromyography.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare muscle fatigue of the tongue muscle before and after giving a continuous load on the tongue by neck surface electromyography.
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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Continuous fatigue of the tongue
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy volunteers:more than 20 years old No disorders involving the jaw, the temporomandibular joint, or Oral function
Key exclusion criteria	Undering treatment of disease
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shigehisa Middle name Last name Kawakami
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code	700-8525
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525 JAPAN
TEL	086-235-6687
Email	s-kawa-10@t.okadai.jp

Public contact
Name of contact person	1st name Shigehisa Middle name Last name Kawakami
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code	700-8525
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525 JAPAN
TEL	086-235-6687
Homepage URL
Email	s-kawa-10@t.okadai.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 700-8525 JAPAN
Tel	086-235-6938
Email	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 09 Month 24 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	2019 Year 09 Month 19 Day
Date of IRB	2020 Year 02 Month 14 Day
Anticipated trial start date	2019 Year 09 Month 24 Day
Last follow-up date	2022 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 09 Month 22 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043396