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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032994
Receipt No. R000037616
Scientific Title The effect of tongue pushing exercise for hyoid movement during swallowing
Date of disclosure of the study information 2018/06/15
Last modified on 2018/06/14

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Basic information
Public title The effect of tongue pushing exercise for hyoid movement during swallowing
Acronym lingual exercise and hyoid movement
Scientific Title The effect of tongue pushing exercise for hyoid movement during swallowing
Scientific Title:Acronym lingual exercise and hyoid movement
Region
Japan

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

Objectives
Narrative objectives1 It is well known that not only tongue strength of elderly decline with aging but also supra hyoid muscle strength do. However, it has not been reported about the relationship between lingual exercise and hyoid kinematic during swallowing. The aim of this study is to investigated if lingual exerice has an effect on the hyoid movement during swallowing in elderly with mild dysphagia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hyoid movement during swallowing observed by videofluoroscopy in 1month later since beginning the training.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 lingual exercise
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The participant with mild dysphagia who agree with this taking part in this study.
Key exclusion criteria The participants with medium to sever dysphagia who can'y follow our instruction
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Hara
Organization Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name Department of Gerontology and Gerodontology,
Zip code
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL 03-5803-5562
Email koji19831031@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Koji Hara
Organization Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name Department of Gerontology and Gerodontology,
Zip code
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL 03-5803-5562
Homepage URL
Email koji19831031@gmail.com

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

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
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

Other administrative information
Date of disclosure of the study information
2018 Year 06 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
2018 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 07 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
2018 Year 06 Month 14 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037616

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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