UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of the new developed dysphagia rehabilitation by using jaw-opening movement
Title of the study (Brief title)	Jawo-openig movement for Dysphagia
Region	Japan

Condition
Condition	the elderly that has complain of dysphagia
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The strength of supra-hyoid muscles decline in aging. It results in insufficient upper esophageal sphincter opening which cause aspiration. The aim of this study is to valid the effect of jaw opening movement as dysphagia rehabilitation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The width of upper esophageal sphincter openin
Key secondary outcomes	The magnitude and velocity of hyoid bone

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	Jaw-opening exercise for a month. They have to exercise it every day.
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 subject who is able to follow an instruction and has agreed with participating this research.
Key exclusion criteria	The subject who can not communicate, such as dementia.
Target sample size	30

Research contact person
Name of lead principal investigator	Haruka Tohara
Organization	Tokyo Medical and Dental University
Division name	Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences,
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL	0358035562
Email	haruka-t@rd5.so-net.ne.jp

Public contact
Name of contact person	Koji Hara
Organization	Tokyo Medical and Dental University
Division name	Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate Schoo
Address	1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN
TEL	0358035562
Homepage URL
Email	koji19831031@gmail.com

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	2017 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 10 Day
Anticipated trial start date	2017 Year 06 Month 26 Day
Last follow-up date	2017 Year 09 Month 15 Day
Date of closure to data entry	2017 Year 10 Month 05 Day
Date trial data considered complete	2017 Year 10 Month 06 Day
Date analysis concluded	2017 Year 10 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 26 Day
Last modified on	2017 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032005