UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041964 |
|---|---|
| Receipt number | 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 15:17:35 |
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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
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
koji19831031@gmail.com
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047895
| 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 |
