UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050598 |
|---|---|
| Receipt number | R000057630 |
| Scientific Title | Children's motion analysis test (1) |
| Date of disclosure of the study information | 2023/03/22 |
| Last modified on | 2023/03/15 16:03:56 |
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Basic information
Public title
Children's motion analysis test
Acronym
Children's motion analysis test
Scientific Title
Children's motion analysis test (1)
Scientific Title:Acronym
Children's motion analysis test (1)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect data about children's gait
Basic objectives2
Others
Basic objectives -Others
To collect data about children's gait
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motion analysis of child
Key secondary outcomes
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
| 13 | months-old | <= |
Age-upper limit
| 95 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Research subjects:Men and women who can walk independently (ages 1 to 7 years and 11 months)
2. Research collaborators: Parents of children who meet 1.
3. Parents and children who live in the suburbs of Tokyo and are able to attend the examination venue
Key exclusion criteria
1. Those who have a fever or respiratory symptoms in their child or parental authority within 2 weeks before visiting the examination venue
2. Those who have a family member living together with a fever or respiratory symptoms during the two weeks prior to visiting the examination venue
3. Children with chronic illness
4. Children with skin symptoms such as severe dermatitis
5. Children who have been pointed out by doctors or public health nurses for skeletal abnormalities in the lower limbs or gait abnormalities in the past
6. Children born prematurely (when giving birth at 22-36 weeks of gestation)
7. Children suffering from infectious diseases
8. Children who are excessively upset and disliked, such as crying for more than 10 minutes during the measurement
9. Children who are prone to tape rashes
10. Children who dislike wearing hats
11. Children with parental authority living together with the following occupations
-Market research/marketing departments of manufacturers/advertising agencies
-Media relations such as TV/radio/newspapers/magazines
-Baby goods specialty store (excluding part-time workers)
-Manufacturers of sanitary products such as sanitary products and diapers
-Research, manufacturing, and sales (retailers, wholesalers, distribution, etc.)
12. Children who currently have unhealed injuries that may affect walking (eg sprains, fractures, etc.)
13. In addition, children who are judged by the person in charge of the test to be unsuitable for the test
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
Sanitary Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-80-8759-1973
fukuda.yuuko1@kao.com
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Kaihara |
Organization
Kao Corporation
Division name
Sanitary Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-80-4090-3386
Homepage URL
kaihara.takahito@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
+81-3-5630-9064
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Children's abilities, mentality, developmental status and gait development
Management information
Registered date
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057630
