UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039550
Receipt No. R000045098
Scientific Title A Study on the infant's motion analysis using Activity Meter.
Date of disclosure of the study information 2020/02/21
Last modified on 2020/02/20 (Ver. 1)

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Basic information
Public title A Study on the infant's motion analysis.
Acronym A Study on the infant's motion analysis.
Scientific Title A Study on the infant's motion analysis using Activity Meter.
Scientific Title:Acronym A Study on the infant's motion analysis.
Region
Japan

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

Objectives
Narrative objectives1 Quantitative analysis for infant's movements using activity meter.
Basic objectives2 Others
Basic objectives -Others Quantitative analysis for infant's movements using activity meter.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correspondence between the movements of infants and the exercise intensity worn by the activity meter.
Key secondary outcomes Exercise intensity by age and development when the activity meter is worn all day at home.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 months-old >=
Gender Male and Female
Key inclusion criteria Healthy infants
Key exclusion criteria -Infants with congenital obstacles or delayed motor development, as diagnosed by a physical during regular medical examinations.
-Infants who refuse to wear an activity meter on their waist.
-Infants who have difficulty coming to the test center from home.
-Infants who do not usually use disposable diapers.

Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Niki
Organization Kao Corporation
Division name Personal Health Care Products Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL 03-5630-9848
Email niki.yosifumi@kao.com

Public contact
Name of contact person
1st name Kanako
Middle name
Last name Seo
Organization Kao Corporation
Division name Personal Health Care Products Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL 03-5630-7486
Homepage URL
Email seo.kanako@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 +81-3-5630-7263
Email morisaki.naoko@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
2020 Year 02 Month 21 Day

Related information
URL releasing protocol None
Publication of results Unpublished

Result
URL related to results and publications None
Number of participants that the trial has enrolled 15
Results 
They asked them to do crawl, pull oneself up, cruising, etc. with the activity meter attached. The exercise intensity at that time was recorded and tabulated. In addition, the duration decreased as the exercise intensity increased. It was suggested that infants' movements before walking could be quantified using an activity meter.
Results date posted
2020 Year 02 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Healthy infants
Participant flow 
the activity meter is worn all day at home.
Adverse events 
None
Outcome measures 
movements of infants and the exercise intensity
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 01 Day
Date of IRB
2014 Year 10 Month 01 Day
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 01 Month 31 Day

Other
Other related information In order to quantify the movement of the infant before walking, the exercise intensity was measured with an activity meter. They asked them to do crawl, pull oneself up, cruising, etc. with the activity meter attached. The exercise intensity at that time was recorded and tabulated. In addition, the duration decreased as the exercise intensity increased. It was suggested that infants' movements before walking could be quantified using an activity meter.

Management information
Registered date
2020 Year 02 Month 20 Day
Last modified on
2020 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045098