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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039100
Receipt No. R000044595
Scientific Title Study of prevention for sports injury in school
Date of disclosure of the study information 2020/01/09
Last modified on 2020/07/12

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Basic information
Public title Study of prevention for sports injury in school
Acronym Study of prevention for sports injury in school
Scientific Title Study of prevention for sports injury in school
Scientific Title:Acronym Study of prevention for sports injury in school
Region
Japan

Condition
Condition sports related injury
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal how to prevent a sports related injury in adolescent student.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes prevalence rate of sports related injury during 1 year with intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 static stretch
exercise for improving balance ability
twice a month
Interventions/Control_2 static stretch
exercise for improving balance ability
once a month
Interventions/Control_3 static stretch
exercise for improving balance ability
once two month
Interventions/Control_4 no intervention
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

Not applicable
Gender Male and Female
Key inclusion criteria Elementary school, junior high school and high school students who agreed to join this study.
Key exclusion criteria Those who can not do exercise which be provided in this study.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Masaru
Middle name
Last name Kadowaki
Organization Shimane University
Division name Department of Orthopaedic surgetry
Zip code 693-8501
Address 89-1, ennya-cho, Izumo
TEL 0853-20-2242
Email masaru11@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Masaru
Middle name
Last name Kadowaki
Organization Shimane University
Division name Department of Orthopaedic surgetry
Zip code 693-8501
Address 89-1, ennya-cho, Izumo
TEL 0853-20-2242
Homepage URL
Email masaru11@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shimane University
Address 89-1, ennya-cho, Izumo
Tel 0853-20-2259
Email kenkyu@med.shimane-u.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 01 Month 09 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
2017 Year 09 Month 15 Day
Date of IRB
2017 Year 10 Month 23 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 09 Day
Last modified on
2020 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044595

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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