UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056991 |
|---|---|
| Receipt number | R000065130 |
| Scientific Title | Influence of Narrowing the Medial Elbow Joint Gap Distance in High School Baseball Players. |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/03/10 10:26:03 |
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Basic information
Public title
Influence of Narrowing the Medial Elbow Joint Gap Distance in High School Baseball Players.
Acronym
Influence of Narrowing the Medial Elbow Joint Gap Distance in High School Baseball Players.
Scientific Title
Influence of Narrowing the Medial Elbow Joint Gap Distance in High School Baseball Players.
Scientific Title:Acronym
Influence of Narrowing the Medial Elbow Joint Gap Distance in High School Baseball Players.
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the Effects of Narrowing the Medial Elbow Joint Gap Distance in High School Baseball Players.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Medial elbow joint space gapping by ultrasound
Key secondary outcomes
Shoulder and Thoracic Spine Extension Range of Motion, Spinal Mobility Test, Body composition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
100 pitches
Interventions/Control_2
The control group received no intervention
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
1, Male high school baseball player.
2,The player who does not have any treatment during this study.
Key exclusion criteria
1, The player who couldn't get consent of participation in this study.
2, Players with a history of elbow surgery or prior injuries before the assessment
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Seita |
| Middle name | |
| Last name | Hasegawa |
Organization
Kimura Orthopedic Clinic
Division name
Rehabilitation
Zip code
360-0811
Address
689-4, Harajima, Kumagaya, Saitama
TEL
048-527-0055
seita121114@icloud.com
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Suzuki |
Organization
Kimura Orthopedic Clinic
Division name
Rehabilitation
Zip code
360-0811
Address
689-4, Harajima, Kumagaya, Saitama
TEL
048-527-0055
Homepage URL
kenta19910509@gmail.com
Sponsor or person
Institute
Kimura Orthopedic Clinic
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Ota College of Medical Technology
Address
1373 Higashinagaoka, Ota, Gunma
Tel
0276-25-2414
kazuki.0838@gmail.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | 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
36
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065130
