UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058769 |
|---|---|
| Receipt number | R000067200 |
| Scientific Title | Descriptive Study of head and lower limbs posture in infancy |
| Date of disclosure of the study information | 2025/08/18 |
| Last modified on | 2025/08/12 16:55:55 |
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Basic information
Public title
Descriptive Study of head and lower limbs posture in infancy
Acronym
Descriptive Study of head and lower limbs posture in infancy
Scientific Title
Descriptive Study of head and lower limbs posture in infancy
Scientific Title:Acronym
Descriptive Study of head and lower limbs posture in infancy
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observe and describe the asymmetry of the lower limbs when the child turns their head in one direction.
Basic objectives2
Others
Basic objectives -Others
Compare the head posture and lower limb posture of children whose parents recognize that they have a head turn preference with those who do not.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. When the child rotates their head in one direction, are the hip joint and knee abduction/flexion angles of the leg on the side of the face closer to the M position standard value than those of the leg on the side of the back of the head?
2. When the child rotates their head in one direction, are the hip joint adducted/extended and the knee extended on the side of the back of the head compared to the side of the face?
Key secondary outcomes
1. Are children whose parents believe they do not have head turn preference more likely to keep their heads in a neutral position than children whose parents believe they do have such a preference
2. Are children whose parents believe they do not have head turn preference more likely to have hip and knee abduction and flexion angles closer to the M position standard values than children whose parents believe they do have such a preference
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
| Not applicable |
Age-upper limit
| 3 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
[Children]
1. Children born at full term (between 37 weeks 0 days and 41 weeks 6 days of pregnancy)
2.Children aged 0 to 3 months
3.Children whose parents or guardians have given their consent to participate in the study
[Parents/Guardians]
1. Parents/guardians who can bring their children to the applicant's laboratory
Key exclusion criteria
[Children]
1. Low birth weight infants (< 2500 g), Small for Gestational Age (SGA) infants
2. Infants born in breech presentation
3. Multiple births
4. Infants with a history of or currently undergoing treatment for diseases (neurological disorders, muscular torticollis, craniosynostosis, clubfoot, and other lower limb abnormalities that may affect the infant's head and lower limb posture)
5. Infants diagnosed with oligohydramnios during pregnancy
6. Infants with a family history of developmental dysplasia of the hip
[Parents/Guardians]
1. Parents/guardians who do not understand Japanese
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3597
chiiki-jim@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Takahashi |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3597
Homepage URL
7310tkhs@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Policy-Based Medical Services Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
Hongo7-3-1 Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2025 | Year | 08 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Research Design
Descriptive Research
2. Recruitment Method
Research participants will be recruited through personal connections, laboratory websites, social media, newborn visits, parenting classes, and poster displays and flyer distribution at medical institutions and childcare centers.
Research participants will read the research description on Google Forms and answer questions related to the inclusion and exclusion criteria for research participation, such as the child's date of birth and birth weight, as well as the schedule for conducting the research.
Researchers will coordinate schedules and notify participants via email of the date and time of the study. If a participant does not meet the inclusion criteria, parents will be informed that they are ineligible to participate in the study.
Management information
Registered date
| 2025 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067200
