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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031838
Receipt No. R000036357
Scientific Title Prevention for throwing injuries -To be compatible with both the prevention and performance-
Date of disclosure of the study information 2018/03/25
Last modified on 2020/09/22

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Basic information
Public title Prevention for throwing injuries
-To be compatible with both the prevention and performance-
Acronym TO investigate the effect of prevention program for throwing medial elbow injury
Scientific Title Prevention for throwing injuries
-To be compatible with both the prevention and performance-
Scientific Title:Acronym TO investigate the effect of prevention program for throwing medial elbow injury
Region
Japan

Condition
Condition throwing medial elbow injury
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of throwing injury prevention program for the prevention of medial elbow injury and improvement of baseball performance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of medial elbow injury(during 1 year)
Ball speed(pitching at baseline and 1 year after)
Swing speed(batting at baseline and 1 year after)
Key secondary outcomes video of throwing form
data of flexibility and muscle strength of shoulder and hip
Finding of sonography of the elbow
Physical data(30m splint and medicine ball throw)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Intervention group
Throwing injuries prevention program(strech oh shouder and hip, skip, squat exercise) & usual warm up program
10 minutes per 1 time, 2 times per a week, during 1 year
Interventions/Control_2 Control group
usual warm up program
10 minutes per 1 time, 2 times per a week, during 1 year
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
13 years-old >=
Gender Male and Female
Key inclusion criteria playing baseball in usual with no problem
Key exclusion criteria Not to be able to do some normal exercises
To have communication disability and not to understand the study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Norikazu
Middle name
Last name Hirose
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 2020011
Address 3-4-1 Higashifushimi, Nishitokyo city, Tokyo
TEL 042-451-1011
Email toitsu_hirose@waseda.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Sakata
Organization Graduate School of Sport Sciences, Waseda University
Division name Hirose office
Zip code 2020011
Address 3-4-1 Higashifushimi, Nishitokyo city, Tokyo
TEL 042-461-1322
Homepage URL
Email jun10767@khaki.plala.or.jp

Sponsor
Institute Faculty of Sport Sciences, Waseda University
Institute
Department

Funding Source
Organization Faculty of Sport Sciences, Waseda University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Office of Research Ethics
Address 1-104, Totsukacho, Shinjuku-ku, Tokyo
Tel 03-5272-1639
Email rinri@list.waseda.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
2018 Year 03 Month 25 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
2018 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 01 Day
Date trial data considered complete
2019 Year 08 Month 01 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 22 Day
Last modified on
2020 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036357

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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