UMIN-CTR Clinical Trial

Basic information
Public title	A fundamental study focused upon functional movement screen training for baseball performance and its disability prevention for baseball injuries
Acronym	A fundamental study focused upon functional movement screen training for baseball performance and its disability prevention for baseball injuries
Scientific Title	A fundamental study focused upon functional movement screen training for baseball performance and its disability prevention for baseball injuries
Scientific Title:Acronym	A fundamental study focused upon functional movement screen training for baseball performance and its disability prevention for baseball injuries
Region	Japan

Condition
Condition	healthy individuals
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the functional movement screen training to predict baseball injuries in high school baseball players and the relationship of the training and baseball performances(ball speed and control).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Functional movement screen score Speed of a pitched ball Control of a pitched ball The time of closed eyes one-leg standing A feeling of fatigue A practice and a game hour time per day during a period of this study. (Before intervention,after 8,12 and 24 weeks of 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	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Functional movement screen training for 15 minute a day will be performed for 4 times a week in 12 weeks.
Interventions/Control_2	A control group performs the usual practice.
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	15 years-old <=
Age-upper limit	18 years-old >=
Gender	Male
Key inclusion criteria	1,Male high school baseball player. 2,The player who does not have any treatment during this study.
Key exclusion criteria	1,The player who couldn't get consent of participation in this study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyokazu Akasaka
Organization	Medical Science, Graduate School of Medicine, Saitama Medical University
Division name	Department of Physical Therapy
Zip code
Address	350-0496 981 Kawakado Moroyamamachi, Irumagun, Saitama
TEL	049-295-8246
Email	akasaka-smc@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kenta Suzuki
Organization	Medical Science, Graduate School of Medicine, Saitama Medical University
Division name	Department of Physical Therapy
Zip code
Address	350-0496 981 Kawakado Moroyamamachi, Irumagun, Saitama
TEL	049-295-8246
Homepage URL
Email	kenta19910509@gmail.com

Sponsor
Institute	Department of Physical Therapy, Medical Science, Graduate School of Medicine, Saitama Medical University
Institute
Department

Funding Source
Organization	Department of Physical Therapy, Medical Science, Graduate School of Medicine, Saitama Medical 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
Address
Tel
Email

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	2017 Year 05 Month 30 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	Completed
Date of protocol fixation	2017 Year 05 Month 19 Day
Date of IRB	2017 Year 05 Month 19 Day
Anticipated trial start date	2017 Year 05 Month 19 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 30 Day
Last modified on	2021 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031587