UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039550 |
|---|---|
| Receipt number | 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 17:19:18 |
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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
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
seo.kanako@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045098
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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