UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036021
Receipt number R000041029
Scientific Title Evaluation of modified diet for dysphagic persons without thickeners. -Investigation with videofluoroscopic and videoendoscopic examination of swallowing-
Date of disclosure of the study information 2019/04/30
Last modified on 2022/07/11 12:57:32

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Basic information

Public title

Evaluation of modified diet for dysphagic persons without thickeners.
-Investigation with videofluoroscopic and videoendoscopic examination of swallowing-

Acronym

Evaluation of modified diet for dysphagic persons without thickeners.

Scientific Title

Evaluation of modified diet for dysphagic persons without thickeners.
-Investigation with videofluoroscopic and videoendoscopic examination of swallowing-

Scientific Title:Acronym

Evaluation of modified diet for dysphagic persons without thickeners.

Region

Japan


Condition

Condition

dysphagia

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of modified diet for dysphagic patients with videofluoroscopic and videoendoscopic examination of swallowing

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

8-Point Penetration-Aspiration Scale, Pharyngeal residue

Key secondary outcomes

Oral transit time, Pharyngeal transit time


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

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Modified diet for dysphagic persons without thickeners

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Dysphagic patients who drink thickened liquid and eat soft food, paste food and jelly.

Key exclusion criteria

Patients with severe dysphagia, cognitive impairment, aphasia and higher brain function.

Target sample size

160


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhisa Domen

Organization

Hyogo College of Medicine

Division name

Department of Rehabilitation Medicine

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture 663-8501, Japan.

TEL

0798-45-6345

Email

domen@neuro-reha.org


Public contact

Name of contact person

1st name
Middle name
Last name Tomoki Nanto

Organization

Hyogo College of Medicine College Hospital

Division name

Department of Rehabilitation

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture 663-8501, Japan.

TEL

0798-45-6345

Homepage URL


Email

s0315028@hotmail.co.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

KURA Welfare Service Corporation

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

2019 Year 04 Month 30 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

Completed

Date of protocol fixation

2019 Year 04 Month 08 Day

Date of IRB

2019 Year 04 Month 01 Day

Anticipated trial start date

2019 Year 04 Month 08 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 27 Day

Last modified on

2022 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041029


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name