UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027942
Receipt No. R000032005
Scientific Title The effect of the new developed dysphagia rehabilitation by using jaw-opening movement
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of the new developed dysphagia rehabilitation by using jaw-opening movement
Acronym Jawo-openig movement for Dysphagia
Scientific Title The effect of the new developed dysphagia rehabilitation by using jaw-opening movement
Scientific Title:Acronym 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
1st name
Middle name
Last name 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,
Zip code
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
1st name
Middle name
Last name Koji Hara
Organization Tokyo Medical and Dental University
Division name Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate Schoo
Zip code
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)

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
2017 Year 07 Month 01 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
2016 Year 09 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.