UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041072 |
|---|---|
| Receipt number | R000044713 |
| Scientific Title | Consistent musculoskeletal examination and health management using "Health Handbook" in elementary, junior high and high schools |
| Date of disclosure of the study information | 2020/07/11 |
| Last modified on | 2024/01/10 09:50:12 |
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Basic information
Public title
Consistent musculoskeletal examination and health management using "Health Handbook" in elementary, junior high and high schools
Acronym
Musculoskeletal examination. at elementary, junior high and high schools
Scientific Title
Consistent musculoskeletal examination and health management using "Health Handbook" in elementary, junior high and high schools
Scientific Title:Acronym
Musculoskeletal examination. at elementary, junior high and high schools
Region
| Japan |
Condition
Condition
musculoskeletal problems
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the musculoskeletal diseases of children by conducting musculoskeletal examinations at elementary, junior high and high schools.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Early detection of motor organ dysfunction (secondary examination)
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Everyone enrolled in elementary and junior high school students of the model school
Key exclusion criteria
those who do not wish to have a medical examination
those who did not have sufficient medical examination
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | KAMADA |
Organization
University of Tsukuba
Division name
Department of Orthopaedic Surgery
Zip code
305-8575
Address
1-1-1Tennodai Tsukuba, Ibaraki
TEL
029-853-3219
hkamada@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | KAMADA |
Organization
University of Tsukuba
Division name
Department of Orthopaedic Surgery
Zip code
305-8575
Address
1-1-1Tennodai Tsukuba, Ibaraki
TEL
029-853-3219
Homepage URL
hkamada@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
University of Tsukuba
Address
1-1-1 Tennodai Tsukuba, Ibaraki
Tel
029-853-3219
hkamada@md.tsukuba.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
| 2020 | Year | 07 | Month | 11 | 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
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collected from the beginning continue to be evaluated. As of 2023, the research is ongoing.
Management information
Registered date
| 2020 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
