UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Test of wearing object to wear.
Title of the study (Brief title)	Test of wearing object to wear.
Region	Japan

Condition
Condition	Healthy adults and healthy infants.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Wearing test of the object to wear by the EMG and motion analysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective assessment of when attaching the object to wear. Muscle load of when attaching the object to wear. Motion analysis of when attaching the object to wear.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	1.The subjects to make sure the wearing of the control products. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 2.The subjects to make sure the wearing of the object to wear A. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 3.The subjects to make sure the wearing of the object to wear B. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 4.The subjects to make sure the wearing of the object to wear C. The subjects tell the measurer When you finish the confirmation. Measurer is measured using the muscle load and motion analysis, and listening to the subjectivity. 5.Repeated 2 - 4 3 times. The measurement is a total of 9 trials.
Interventions/Control_2	1.The subjects to make sure the wearing of the control products. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 2.The subjects to make sure the wearing of the object to wear A. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 3.The subjects to make sure the wearing of the object to wear C. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 4.The subjects to make sure the wearing of the object to wear B. The subjects tell the measurer When you finish the confirmation. Measurer is measured using the muscle load and motion analysis, and listening to the subjectivity. 5.Repeated 2 - 4 3 times. The measurement is a total of 9 trials.
Interventions/Control_3	1.The subjects to make sure the wearing of the control products. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 2.The subjects to make sure the wearing of the object to wear B. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 3.The subjects to make sure the wearing of the object to wear A. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 4.The subjects to make sure the wearing of the object to wear C. The subjects tell the measurer When you finish the confirmation. Measurer is measured using the muscle load and motion analysis, and listening to the subjectivity. 5.Repeated 2 - 4 3 times. The measurement is a total of 9 trials.
Interventions/Control_4	1.The subjects to make sure the wearing of the control products. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 2.The subjects to make sure the wearing of the object to wear B. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 3.The subjects to make sure the wearing of the object to wear C. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 4.The subjects to make sure the wearing of the object to wear A. The subjects tell the measurer When you finish the confirmation. Measurer is measured using the muscle load and motion analysis, and listening to the subjectivity. 5.Repeated 2 - 4 3 times. The measurement is a total of 9 trials.
Interventions/Control_5	1.The subjects to make sure the wearing of the control products. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 2.The subjects to make sure the wearing of the object to wear C. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 3.The subjects to make sure the wearing of the object to wear A. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 4.The subjects to make sure the wearing of the object to wear B. The subjects tell the measurer When you finish the confirmation. Measurer is measured using the muscle load and motion analysis, and listening to the subjectivity. 5.Repeated 2 - 4 3 times. The measurement is a total of 9 trials.
Interventions/Control_6	1.The subjects to make sure the wearing of the control products. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 2.The subjects to make sure the wearing of the object to wear C. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 3.The subjects to make sure the wearing of the object to wear B. The subjects tell the measurer When you finish the confirmation. Measurer measures the muscle load and motion analysis, and listening to the subjectivity. 4.The subjects to make sure the wearing of the object to wear A. The subjects tell the measurer When you finish the confirmation. Measurer is measured using the muscle load and motion analysis, and listening to the subjectivity. 5.Repeated 2 - 4 3 times. The measurement is a total of 9 trials.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Protector -Healthy. -A person who living with infant of research object. Infant -Healthy.
Key exclusion criteria	Protector -A person who feel pain in the body and changing diaper. Infant -Infants who are infected with dermatitis.
Target sample size	20

Research contact person
Name of lead principal investigator	Niki Yoshifumi
Organization	Kao Corporation
Division name	R&D -Development Research- Personal Health Care Research Integrative Physiology Project.
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	03-5630-9848
Email	niki.yoshifumi@kao.co.jp

Public contact
Name of contact person	Kanako Seo
Organization	Kao Corporation
Division name	R&D -Development Research- Personal Health Care Research Integrative Physiology Project.
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	03-5630-7486
Homepage URL
Email	seo.kanako@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Self funding
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	花王株式会社東京研究所（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 25 Day
Anticipated trial start date	2016 Year 04 Month 19 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	2016 Year 03 Month 04 Day
Last modified on	2016 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024606