UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes on standing of forearm function and performance of university semi-hard baseball players.
Title of the study (Brief title)	Changes on standing of forearm function and performance of university semi-hard baseball players.
Region	Japan

Condition
Condition	University semi-hard baseball players. The shoulder joint and the elbow joint without pain, the person that can best pitching.
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Throwing elbow injury is said to be an important cause of valgus stress applied to the elbow joint. Prevention of throwing elbow injury requires reduction of valgus stress. Previous studies show that loading is applied to the forearm muscle during throwing motion and it is considered important for prevention of throwing elbow injury. It is aimed to discover deterioration of forearm function and performance deterioration before and after the season, and to help conditioning and prevention of disability.
Basic objectives2	Others
Basic objectives -Others	Confirm temporal changes in physical function and performance.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	I use the speed of pitched ball as an evaluation index. I measure twice before and after the league games. And confirm the change of 2 points.
Key secondary outcomes	I use forearm function as evaluation item. I measure five items of grip strength, pinch force, muscle tightness, ulnar carpi flexor muscle strength, muscle hardness. Measure twice before and after the league game.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	With a period of about 2 months, measure the 7 items twice.
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	20 years-old <=
Age-upper limit	29 years-old >=
Gender	Male
Key inclusion criteria	University semi-hard baseball players Capture all players regardless of position
Key exclusion criteria	Currently, there are orthopedic disease or pain, such as the shoulder, elbow, what our best pitching is difficult.
Target sample size	20

Research contact person
Name of lead principal investigator	Masaaki Sakamoto
Organization	Gunma University
Division name	Graduate School of Health Sciences
Address	3-39-22 Showa, Maebashi, Gunma
TEL	027-220-8972
Email	msaka@gunma-u.ac.jp

Public contact
Name of contact person	Shota Suzuki
Organization	Gunma university
Division name	Graduate School of Health Sciences
Address	3-39-22 Showa, Maebashi, Gunma
TEL	09046697086
Homepage URL
Email	h171c012@gunma-u.ac.jp

Sponsor
Institute	Gunma university
Institute
Department

Funding Source
Organization	Ministry of Education,Culture,Sports,Science and Technology.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	群馬大学医学部昭和キャンパス(群馬県)

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 20 Day
Anticipated trial start date	2018 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 08 Month 20 Day
Last modified on	2019 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038434