UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059671 |
|---|---|
| Receipt number | R000068256 |
| Scientific Title | Characteristics of Humeral Head Translation Induced by Consecutive Pitching in High School Baseball Players |
| Date of disclosure of the study information | 2025/11/06 |
| Last modified on | 2025/11/09 17:04:10 |
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Basic information
Public title
Characteristics of Humeral Head Translation Induced by Consecutive Pitching in High School Baseball Players
Acronym
Characteristics of Humeral Head Translation Induced by Consecutive Pitching in High School Baseball Players
Scientific Title
Characteristics of Humeral Head Translation Induced by Consecutive Pitching in High School Baseball Players
Scientific Title:Acronym
Characteristics of Humeral Head Translation Induced by Consecutive Pitching in High School Baseball Players
Region
| Japan |
Condition
Condition
healthy baseball players
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively evaluate immediate anteroposterior humeral head translation after repetitive pitching using ultrasonographic imaging, and to identify the factors and characteristics associated with anteroposterior translation following repetitive pitching in high school baseball pitchers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Humeral head-glenoid anteroposterior distance and acromiohumeral distance.
Distance between the humeral head-glenoid anteroposterior distance, and acromiohumeral distance measured before pitching, and after 20, 40, 60, and 80 pitches, as well as after pitching.
Key secondary outcomes
Pre- and post-pitching assessments: shoulder range of motion; scapular and thoracic spine alignment; pitching mechanics; jump performance; body composition; and questionnaire data.
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
5 sets of 20 pitches
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy high school baseball players
Key exclusion criteria
(1) Participants who cannot or do not provide informed consent to participate.
(2) Participants with a history of orthopedic surgery involving the extremities or trunk.
(3) Participants with a history of glenohumeral (shoulder) joint dislocation.
(4) Participants who currently have structural abnormalities of the shoulder joint or thoracic cage (e.g., scoliosis, kyphosis).
(5) Participants who are currently sidelined from club activities due to injury.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Graduate school of Saitama Medical University
Division name
Department of Medicine
Zip code
3500496
Address
981 Kawakado, Moroyama, Iruma, Saitama, Japan
TEL
049-295-1001
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Suzuki |
Organization
Saitama medical university graduate school
Division name
Department of Medicine
Zip code
3500496
Address
981 Kawakado, Moroyama, Iruma, Saitama, Japan
TEL
049-295-1001
Homepage URL
kenta-suzuki@umin.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Saitama Medical University
Address
38 Morohongo, Moroyama, Iruma, Saitama, Japan
Tel
0492762143
rinri@saitama-med.ac.jp
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
| 2025 | Year | 11 | Month | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068256
