UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028215 |
|---|---|
| Receipt number | 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 09:54:39 |
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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
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
reha@nishikuma.com
Sponsor or person
Institute
SOUSEIKAI Nishi-Kumamoto Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032296
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
