UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study
Title of the study (Brief title)	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	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,
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL	03-5803-5562
Email	koji19831031@gmail.com

Public contact
Name of contact person	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,
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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