UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040856 |
|---|---|
| Receipt number | R000035141 |
| Scientific Title | The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position. |
| Date of disclosure of the study information | 2020/06/22 |
| Last modified on | 2021/12/24 21:44:10 |
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Basic information
Public title
The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position.
Acronym
The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position.
Scientific Title
The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position.
Scientific Title:Acronym
The effect of tongue lift movement on hyoid bone and hyoid and laryngeal position.
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of tongue lift movement on hyoid and laryngeal position in healthy volunteers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity of supra hyoid muscle
Xray image of hyoid bone and laryngeal position
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Health volunteers who have no dysphagic symptoms
Key exclusion criteria
People having a medical history that causes dysphagia
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Jin |
| Middle name | |
| Last name | Magara |
Organization
Niigata University, Medical & Dental hospital
Division name
Unit of dysphagia rehabilitation
Zip code
9518514
Address
Niigata University Graduate School of Medical and Dental Sciences 2-5274 Gakkocho-dori, Chuo-ku, Nii
TEL
0252272999
jin-m@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Jin |
| Middle name | |
| Last name | Magara |
Organization
Niigata University Medical & Dental Hospital
Division name
Unit of dysphagia rehabilitation
Zip code
9518514
Address
Niigata University Graduate School of Medical and Dental Sciences 2-5274 Gakkocho-dori, Chuo-ku, Nii
TEL
0252272999
Homepage URL
jin-m@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata 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
Ethics Committee of the Niigata University
Address
757 Ichiban-cho Asahimachi-dori Chu-o-ku, Niitata city
Tel
025-227-2005
joho@med.niigata-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2017-0328
Org. issuing International ID_1
2017-0328
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1111/joor.12988
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Results of young volunteers has been published.
Management information
Registered date
| 2020 | Year | 06 | Month | 22 | Day |
Last modified on
| 2021 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035141
