UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055858 |
|---|---|
| Receipt number | R000063810 |
| Scientific Title | Relationship between Physical Fitness Test Results and orthopedic health check in the schoolchildren |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2024/10/16 22:08:10 |
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Basic information
Public title
Relationship between Physical Fitness Test Results and orthopedic health check in the schoolchildren
Acronym
Relationship between Physical Fitness Test Results and orthopedic health check in the schoolchildren
Scientific Title
Relationship between Physical Fitness Test Results and orthopedic health check in the schoolchildren
Scientific Title:Acronym
Relationship between Physical Fitness Test Results and orthopedic health check in the schoolchildren
Region
| Japan |
Condition
Condition
Children, Elementary School Students, Junior High School Students
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the relationship between the health status of the musculoskeletal system and physical fitness levels in children, elementary, and junior high school students, and to evaluate the reliability of the orthopedic health check evaluation items.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical fitness test conducted in accordance with the guidelines for the Ministry of Education, Culture, Sports, Science and Technology (MEXT), Early Childhood Physical Fitness Ability Test, and New Physical Fitness Test implementation procedures.
Footprint.
Posture Measurement Device.
Foot Pressure Sensor.
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
| 4 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nara Bunka Kindergarten, five elementary schools in Tawaramoto Town, Shiki District, Nara Prefecture, and two junior high schools in Koryo Town, Nara Prefecture.
Key exclusion criteria
Individuals who have not undergone the measurements.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Umeyama |
Organization
Kio University
Division name
research student
Zip code
6350832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
b5108949@kio.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Umeyama |
Organization
Kio University
Division name
research student
Zip code
6350832
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
b5108949@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
b5108949@kio.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
| 2024 | Year | 10 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The physical fitness test is conducted by the assigned teachers at each school in accordance with the guidelines for the Early Childhood Physical Fitness Ability Test and the New Physical Fitness Test by the Ministry of Education, Culture, Sports, Science and Technology (MEXT).
orthopedic health check is conducted by the school physicians at each school in accordance with the ordinance that partially amends the enforcement regulations of the School Health and Safety Act by the Ministry of Education, Culture, Sports, Science and Technology (MEXT).
Foot Balance Measurement Device, Posture Measurement Device, and Plantar Pressure Sensor were used.
Management information
Registered date
| 2024 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063810
