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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034271
Receipt No. R000036130
Scientific Title Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study
Date of disclosure of the study information 2018/09/26
Last modified on 2018/09/26

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Basic information
Public title Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study
Acronym The effect of Jaw opening exercise on the supra hyoid muscle
Scientific Title Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study
Scientific Title:Acronym The effect of Jaw opening exercise on the supra hyoid muscle
Region
Japan

Condition
Condition form light to mild dysphagia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Jaw-openig exercise (JOE) has been reported that it improved the swallowing function and hyoid movement during swallowing. However, It is unknown if JOE effects to increase the volume and quality of the supra hyoid muscle. This study aim to clarify how JOE effect the architect of sprahyoid muscle on a randomized control study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes volume, quality and strength of suprahyoid muscle
Key secondary outcomes hyoid elevation, nutritional status, swallowing function, meaning time

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Jaw-opning exercise and regularly evaluation of swallowing function
Interventions/Control_2 regularly evaluation of swallowing function
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 Agreement of taking part in this study.
Be able to undersand the instruction by the trainer.
No sever general condition
Key exclusion criteria Less than the level 4 of FOIS(Functional oral intake scale). Having neural muscular disease. Having bulbar palsy.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Hara
Organization Graduate School of Medical and Dental Sciences,
Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, 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 Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, 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 Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 09 Month 26 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
In intervention group, the are of muscle (MA) of geniohyoid muscle has increased significantly after intervention period, while MA of geniohyoid has decreased significantly after intervention period. 
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 Completed
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2018 Year 08 Month 08 Day
Date trial data considered complete
2018 Year 08 Month 22 Day
Date analysis concluded
2018 Year 08 Month 28 Day

Other
Other related information BMI in both group decreased after 3month follow up.

Management information
Registered date
2018 Year 09 Month 26 Day
Last modified on
2018 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036130

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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