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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025609
Receipt No. 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

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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
Email 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
Email sato.ohp@tmd.ac.jp

Sponsor
Institute tokyo medical and dental university
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029466

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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