UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027942
Receipt number 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 17:34:39

* 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 or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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

Value
https://center6.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