UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between the laterality of shoulder muscle strength and the laterality of humeral torsion angle in baseball experienced person.
Title of the study (Brief title)	The relationship between the laterality of shoulder muscle strength and the laterality of humeral torsion angle in baseball experienced person.
Region	Japan

Condition
Condition	The healthy adults with baseball experience.
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to investigate whether the difference in the shoulder muscular strength of baseball experienced persons is recognized between the position including the laterality of humeral torsion angle and the excluded position.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Shoulder muscle strength(including laterality if humeral torsion and excluding laterality of humeral torsion).
Key secondary outcomes	Humeral torsion angle. Grip strength.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Shoulder muscle strength is measured. Measurement position is including laterality of humeral torsion and excluding laterality of humeral torsion.
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	40 years-old >
Gender	Male
Key inclusion criteria	1, The person 20 years or older and younger than 40 years at the time of obtaining consent. 2, The person that a shoulder does not have a symptom(pain or instability). 3, The person who has experienced baseball at the age of a primary schoolchild. 4, The person that the control group does not have the experience of overhead sports. 5, The person that a document agreement was provided by the free will of the person after having received the explanation of this study.
Key exclusion criteria	1, The person younger than 20 years old at the time of obtaining consent. 2, The person 40 years or older at the time of obtaining consent. 3, The person with symptom on a shoulder(pain or instability). 4, The person that a document agreement by the free will of the person was not provided on participating to this study.
Target sample size	60

Research contact person
Name of lead principal investigator	Atsushi Takeda
Organization	Osaka Health Science University
Division name	Graduate school of Osaka Health Science University
Address	1-9-27, Temma, Kita-ku Osaka-shi, Osaka, Japan
TEL	06-6354-0091
Email	a.takeda.pt@gmail.com

Public contact
Name of contact person	Atsushi Takeda
Organization	Osaka Health Science University
Division name	Graduate school of Osaka Health Science University
Address	1-9-27, Temma, Kita-ku Osaka-shi, Osaka, Japan
TEL	06-6354-0091
Homepage URL
Email	a.takeda.pt@gmail.com

Sponsor
Institute	Osaka Health Science University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 01 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	2017 Year 01 Month 20 Day
Last modified on	2018 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029630