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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028215
Receipt No. R000032296
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-
Date of disclosure of the study information 2017/07/24
Last modified on 2019/09/04

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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

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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