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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041964
Receipt No. R000047895
Scientific Title Dysphagia assessment focused on jaw-opening movement
Date of disclosure of the study information 2020/10/02
Last modified on 2020/10/01

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Basic information
Public title Dysphagia assessment focused on jaw-opening movement
Acronym jaw-opening movement and dysphagia assessment
Scientific Title Dysphagia assessment focused on jaw-opening movement
Scientific Title:Acronym Dysphagia assessment focused on jaw-opening movement
Region
Japan

Condition
Condition patients with dysphagia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 jaw-opening muscle is correspond with suprahyoid muscle. Suprahyoid muscle plays important role of achieving swallowing movement including jaw-opening speed tor jaw-opening force. thus, we aim to study if jaw-opening movement can assess swallowing function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes severity of dysphagia and parameters of suprahyoid muscle
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 participant who can open their mouth with our instruction
Key exclusion criteria nothing special
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Hatuka
Middle name
Last name Tohara
Organization Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University
Division name Dysphagia Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences,
Zip code 1138510
Address 1-5-45, Yushima, Bunkyoku, Tokyo, Japan
TEL 03-58035562
Email haruka-t@rd5.so-net.ne.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Hara
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Dysphagia Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical an
Zip code 1138510
Address 1-5-45, Yushima, Bunkyoku, Tokyo, Japan
TEL 03-58035562
Homepage URL
Email koji19831031@gmail.com

Sponsor
Institute Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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 Tokyo Medical and Dental Univerisity ethics commity
Address 1-5-45, Yushima, Bunkyoku, Tokyo, Japan
Tel 03-5803-4712
Email jimubu-sanren.adm@tmd.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 D2014-047
Org. issuing International ID_1 Tokyo Medical and Dental Univerisity ethics commity
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学歯学部附属病院摂食嚥下リハビリテーション外来

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 02 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
2020 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 03 Day
Last follow-up date
2023 Year 10 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information we are going to clarify the relationship between jaw-opening movement including jaw-opening force and jaw-opening speed and age, dysphagia and parameters related to suprahyoid muscle.

Management information
Registered date
2020 Year 10 Month 01 Day
Last modified on
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047895

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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