UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059362 |
|---|---|
| Receipt number | R000067897 |
| Scientific Title | Development of a Shoulder Injury Prevention Program for High School Female Baseball Players |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/10 11:48:03 |
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Basic information
Public title
Development of a Shoulder Injury Prevention Program for High School Female Baseball Players
Acronym
Development of a Shoulder Injury Prevention Program for High School Female Baseball Players
Scientific Title
Development of a Shoulder Injury Prevention Program for High School Female Baseball Players
Scientific Title:Acronym
Development of a Shoulder Injury Prevention Program for High School Female Baseball Players
Region
| Japan |
Condition
Condition
Throwing related shoulder injuries
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the preventive effect of a shoulder injury prevention program on shoulder injuries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of shoulder injuries (24 weeks)
Key secondary outcomes
Shoulder muscle and shoulder grdle strength (12 weeks)
Shoulder range of motion (12 weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group
Throwing-related shoulder injury prevention program (strength training of the shoulder joint and scapular girdle) plus routine team practice.
The throwing-related shoulder injury prevention program is performed for 10 minutes per session, 2 times per a week, during 24 weeks.
Interventions/Control_2
Routine team practice only.
during 24 weeks
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
| 16 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Female
Key inclusion criteria
Participants who are able to participate in regular school club (team) activities.
Participants with baseball experience prior to entering high school.
Key exclusion criteria
Participants with a history of shoulder fracture.
Participants with a history of upper-limb paralysis/paresis due to cervical nerve pathology.
Target sample size
191
Research contact person
Name of lead principal investigator
| 1st name | Norikazu |
| Middle name | |
| Last name | Hirose |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
202-0021
Address
3-4-1 Higashifushimi, Nishitokyo city, Tokyo
TEL
042-451-1011
toitsu_hirose@waseda.jp
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Okamura |
Organization
Graduate School of Sport Sciences, Waseda University
Division name
Hirose office
Zip code
202-0021
Address
3-4-1 Higashifushimi, Nishitokyo city, Tokyo
TEL
042-461-1322
Homepage URL
s-okamura@akane.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda 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
Office of Research Ethics
Address
1-104, Totsukacho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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 | 10 | Month | 10 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | 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 | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067897
