UMIN-CTR Clinical Trial

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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