UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025609 |
|---|---|
| Receipt number | R000029466 |
| Scientific Title | The influence of the training using the tongue attachment |
| Date of disclosure of the study information | 2017/01/15 |
| Last modified on | 2017/01/10 22:37:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The influence of the training using the tongue attachment
Acronym
The influence of the training using the tongue attachment
Scientific Title
The influence of the training using the tongue attachment
Scientific Title:Acronym
The influence of the training using the tongue attachment
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of the tongue attachment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Before and after the wearing of the device
Oral cavity function evaluation
Key secondary outcomes
Evaluation of swallowing function
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
put on a tongue attachment and carry out training
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
healty adults
Key exclusion criteria
Person with the functional disorder of the tongue
Person who has a wound to a tongue
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | haruka tohara |
Organization
tokyo medical and dental university
Division name
gerodontology
Zip code
Address
1-5-45 yushima bunkyo-ku 113-8549 japan
TEL
03-5803-5750
haruka-t@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | marie sato |
Organization
tokyo medical and dental university
Division name
gerodontology
Zip code
Address
1-5-45 yushima bunkyo-ku 113-8549 japan
TEL
03-5803-5560
Homepage URL
sato.ohp@tmd.ac.jp
Sponsor or person
Institute
tokyo medical and dental university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
東京医科歯科大学歯学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 15 | 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
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | 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
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029466
