UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027687
Receipt number R000031718
Scientific Title A preliminary study on the sole sense of Japanese and Thai
Date of disclosure of the study information 2017/06/12
Last modified on 2017/12/07 10:06:36

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Basic information

Public title

A preliminary study on the sole sense of Japanese and Thai

Acronym

Survey on sole sense

Scientific Title

A preliminary study on the sole sense of Japanese and Thai

Scientific Title:Acronym

Survey on sole sense

Region

Japan Asia(except Japan)


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Consider the difference in sole sense and gait of Japanese and Thai

Basic objectives2

Others

Basic objectives -Others

Consider the difference in sole sense and gait of Japanese and Thai

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sole sense by Vibratory Sensory Analyzer

Key secondary outcomes

Measurement values of gait, Health consciousness questionnaire


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

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Measurement of sole sense -> Measurement of gait -> Questionnaire of health consciousness

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy Male and Female

Key exclusion criteria

-Subjects with difficult walking
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sudo Motoki

Organization

Kao Corporation

Division name

R&D -Development Research- Personal Health Care Research Health Care Solutions.

Zip code


Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

+81-3-5630-7486

Email

sudo.motoki@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomisaki Masumi

Organization

Kao Corporation

Division name

R&D -Development Research- Personal Health Care Research Health Care Solutions.

Zip code


Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

+81-3-5630-7486

Homepage URL


Email

sudo.motoki@kao.co.jp


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

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

花王株式会社(東京都)、Kao Industrial (Thailand) Co., Ltd.(タイ)


Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 12 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

2017 Year 06 Month 06 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 14 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

2017 Year 06 Month 08 Day

Last modified on

2017 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name