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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021335
Receipt No. R000024606
Scientific Title Test of wearing object to wear.
Date of disclosure of the study information 2016/04/01
Last modified on 2016/04/29

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Basic information
Public title Test of wearing object to wear.
Acronym Test of wearing object to wear.
Scientific Title Test of wearing object to wear.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Niki Yoshifumi
Organization Kao Corporation
Division name R&D -Development Research- Personal Health Care Research Integrative Physiology Project.
Zip code
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
1st name
Middle name
Last name Kanako Seo
Organization Kao Corporation
Division name R&D -Development Research- Personal Health Care Research Integrative Physiology Project.
Zip code
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

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)

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 花王株式会社東京研究所(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 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
2016 Year 01 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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