UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of tongue pushing exercise for hyoid movement during swallowing
Title of the study (Brief title)	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	Koji Hara
Organization	Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name	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	Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name	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	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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 14 Day
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

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Publication of results	Unpublished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