UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038077 |
|---|---|
| Receipt number | R000043396 |
| Scientific Title | Intervention study on muscle fatigue assessment of tongue muscle by neck surface electromyography |
| Date of disclosure of the study information | 2019/09/24 |
| Last modified on | 2022/08/22 14:18:43 |
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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
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
s-kawa-10@t.okadai.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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043396
| 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 |
