UMIN-CTR Clinical Trial

Basic information
Public title	Comparison and Analysis of Shoulder Joint Angle between Shadow Pitting and Full Power Pitching in Baseball Players who are in growing period. -Evaluation and Analysis Using Three-Dimensional Motion Analyzer-
Acronym	Comparison and Analysis of Shoulder Joint Angle between Shadow Pitting and Full Power Pitching in Baseball Players who are in growing period.
Scientific Title	Comparison and Analysis of Shoulder Joint Angle between Shadow Pitting and Full Power Pitching in Baseball Players who are in growing period. -Evaluation and Analysis Using Three-Dimensional Motion Analyzer-
Scientific Title:Acronym	Comparison and Analysis of Shoulder Joint Angle between Shadow Pitting and Full Power Pitching in Baseball Players who are in growing period.
Region	Japan

Condition
Condition	Healthy subject
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Shadow pitching is used as a part of rehabilitation of throwing injuries, including little league elbow and little league shoulder in the period of growth. We will examine the degree of estrangement between the shadow pitching and full power pitching to review instruction method.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Pitting movement (shadow pitting and full power pitching) maximum angle of internal rotation, external rotation, horizontal abduction and horizontal adduction
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Subject should pit shadow and Full Power Interchangebly five times.
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	12 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1, Signing of ICF needs before joining this study. 2, Subject who belong to the baseball club of junior high school
Key exclusion criteria	1. Subject with history of orthopedic surgery. 2. Subject with serious obstacles that restrict pitching. 3. Subject with pain at the time of measurement that restrict joint movement and flexibility.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Yamaguchi
Organization	SOUSEIKAI Nishi-Kumamoto Hospital
Division name	Orthopedics
Zip code	8614157
Address	1012 KOGA, TOMIAI-MACHI, MINAMI-KU, KUMAMOTO 861-4157, JAPAN
TEL	096-358-1118
Email	inoue@nishikuma.com

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Nakayama
Organization	SOUSEIKAI Nishi-Kumamoto Hospital
Division name	Department of rehabilitation
Zip code	8614157
Address	1012 KOGA, TOMIAI-MACHI, MINAMI-KU, KUMAMOTO 861-4157, JAPAN
TEL	096-358-1118
Homepage URL
Email	reha@nishikuma.com

Sponsor
Institute	SOUSEIKAI Nishi-Kumamoto Hospital
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)

IRB Contact (For public release)
Organization	Hakata Clinic Institutional Review Board
Address	6-18 Tenyamachi, Hakata-ku, Fukuoka
Tel	0922387701
Email	miyako-koga@lta-med.com

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	医療法人相生会　にしくまもと病院 (熊本市）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 24 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	16
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	Terminated
Date of protocol fixation	2017 Year 05 Month 15 Day
Date of IRB	2017 Year 05 Month 19 Day
Anticipated trial start date	2017 Year 07 Month 24 Day
Last follow-up date	2019 Year 08 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 13 Day
Last modified on	2019 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032296