UMIN-CTR Clinical Trial

Basic information
Public title	Infant Motion Analysis Test (1)
Acronym	Infant Motion Analysis Test
Scientific Title	Infant Motion Analysis Test (1)
Scientific Title:Acronym	Infant Motion Analysis Test
Region	Japan

Condition
Condition	Healthy infants
Classification by specialty	Not applicable Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Motion analysis of an infant
Basic objectives2	Others
Basic objectives -Others	Motion analysis of an infant
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Motion analysis of an infant
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	1.Putting reflective markers and EMG sensors on skin 2.Perform the specified operation in the specified area in a state of wearing diaper or clothing
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	3 months-old <=
Age-upper limit	36 months-old >=
Gender	Male and Female
Key inclusion criteria	Healthy male and female infants (12 months to 30 months old)
Key exclusion criteria	1.The infant with chronic sickness. 2.The infant has a severe skin trouble. 3.The infant has an infective disease. 4.The infant who dislikes measurement excessively. 5.The infant who is prone to get rash due to adhesion. 6.Infants reluctant to wear hats 7.In the case of parental authority of the target infant takes in the following occupations -Market Research/Marketing department of the manufacturer/Advertising agency-TV/Radio/Newspaper/Magazine media related -Specialty stores of baby goods (excluding part-time jobs) -Manufacturers, research, and sales(retail stores, wholesalers, distribution, etc.) related to sanitary products. 8.The infant who judged that a test staff in attendance was unsuitable as a test participant.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Okuda
Organization	Kao Corporation
Division name	Sanitary Products Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-
TEL	0285-68-7432
Email	okuda.yasuyuki@kao.com

Public contact
Name of contact person	1st name Kyoko Middle name Last name Tsuge
Organization	Kao Corporation
Division name	Sanitary Products Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-
TEL	0285-68-7379
Homepage URL
Email	tsuge.kyoko@kao.com

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)

IRB Contact (For public release)
Organization	Human Research Ethics Committee, Kao Corporation
Address	2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel	+81-3-5630-9220
Email	uesaka.toshio@kao.com

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）

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 05 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 03 Month 26 Day
Date of IRB	2019 Year 03 Month 26 Day
Anticipated trial start date	2019 Year 04 Month 05 Day
Last follow-up date	2019 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 01 Month 26 Day

Other
Other related information

Management information
Registered date	2019 Year 04 Month 05 Day
Last modified on	2022 Year 01 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041490