UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034271
Receipt number R000036130
Scientific Title Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study
Date of disclosure of the study information 2018/09/26
Last modified on 2018/09/26 11:53:32

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Basic information

Public title

Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study

Acronym

The effect of Jaw opening exercise on the supra hyoid muscle

Scientific Title

Jaw openging exercise effect swallowing function and architect of supahyoid muscle: A randomized control study

Scientific Title:Acronym

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

1st name
Middle name
Last name 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,

Zip code


Address

1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN

TEL

03-5803-5562

Email

koji19831031@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name 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,

Zip code


Address

1-5-45, Yushima, Bunkyo, Tokyo 113-8549, JAPAN

TEL

03-5803-5562

Homepage URL


Email

koji19831031@gmail.com


Sponsor or person

Institute

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Institute

Department

Personal name



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)



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

2018 Year 09 Month 26 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

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.

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

Completed

Date of protocol fixation

2018 Year 04 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036130


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name