UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A preliminary study on the sole sense of Japanese and Thai
Title of the study (Brief title)	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	Sudo Motoki
Organization	Kao Corporation
Division name	R&D -Development Research- Personal Health Care Research Health Care Solutions.
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	Tomisaki Masumi
Organization	Kao Corporation
Division name	R&D -Development Research- Personal Health Care Research Health Care Solutions.
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
Institute	Kao Corporation
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031718