UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017859
Receipt number R000020694
Scientific Title Study to establish a new masticatory test for dysphagia
Date of disclosure of the study information 2015/06/15
Last modified on 2015/06/10 14:24:25

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Basic information

Public title

Study to establish a new masticatory test for dysphagia

Acronym

Study to establish a new masticatory test for dysphagia

Scientific Title

Study to establish a new masticatory test for dysphagia

Scientific Title:Acronym

Study to establish a new masticatory test for dysphagia

Region

Japan


Condition

Condition

dysphagia

Classification by specialty

Rehabilitation medicine Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Among patients with dysphagia taking food substances which doesn't require mastication, we investigate how many patients who can eat rice crackers there are and want to make a test to evaluate the masticatory function of dysphagia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

aspiration, penetration, oral residue, pharyngeal residue, function of bolus preparation

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

When patients with dysphagia eat rice crackers, we investigate whether or not they can eat them as safely as they eat meals not required mastication.

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

20 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

a patient with dysphagia who takes meal which doesn't require mastication

Key exclusion criteria

a patient who cannot take meal through his or her mouth

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruka Tohara

Organization

Tokyo medical and dental university

Division name

Tokyo medical and dental university hospital faculty of dentistry, Gerodontology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN

TEL

03-5803-4560

Email

haruka-t@rd5.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Itoe Tagashira

Organization

Tokyo medical and dental university

Division name

Tokyo medical and dental university hospital faculty of dentistry, Gerodontology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN

TEL

03-5803-5562

Homepage URL


Email

i.tagashira.gerd@tmd.ac.jp


Sponsor or person

Institute

Tokyo medical and dental university hospital faculty of dentistry,Gerodontology

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

東京医科歯科大学歯学部附属病院(Tokyo medical and dental university hospital faculty of dentistry)(東京都)、新八千代病院(Shinyachiyo hospital)(千葉県)


Other administrative information

Date of disclosure of the study information

2015 Year 06 Month 15 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

Open public recruiting

Date of protocol fixation

2015 Year 03 Month 25 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 10 Day

Last modified on

2015 Year 06 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020694


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name