UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031838 |
|---|---|
| Receipt number | R000036357 |
| Scientific Title | Prevention for throwing injuries -To be compatible with both the prevention and performance- |
| Date of disclosure of the study information | 2018/03/25 |
| Last modified on | 2026/06/09 08:20:06 |
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Basic information
Public title
Prevention for throwing injuries
-To be compatible with both the prevention and performance-
Acronym
TO investigate the effect of prevention program for throwing medial elbow injury
Scientific Title
Prevention for throwing injuries
-To be compatible with both the prevention and performance-
Scientific Title:Acronym
TO investigate the effect of prevention program for throwing medial elbow injury
Region
| Japan |
Condition
Condition
throwing medial elbow injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of throwing injury prevention program for the prevention of medial elbow injury and improvement of baseball performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of medial elbow injury(during 1 year)
Ball speed(pitching at baseline and 1 year after)
Swing speed(batting at baseline and 1 year after)
Key secondary outcomes
video of throwing form
data of flexibility and muscle strength of shoulder and hip
Finding of sonography of the elbow
Physical data(30m splint and medicine ball throw)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group
Throwing injuries prevention program(strech oh shouder and hip, skip, squat exercise) & usual warm up program
10 minutes per 1 time, 2 times per a week, during 1 year
Interventions/Control_2
Control group
usual warm up program
10 minutes per 1 time, 2 times per a week, during 1 year
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
| 6 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
playing baseball in usual with no problem
Key exclusion criteria
Not to be able to do some normal exercises
To have communication disability and not to understand the study
Target sample size
1000
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
2020011
Address
3-4-1 Higashifushimi, Nishitokyo city, Tokyo
TEL
042-451-1011
toitsu_hirose@waseda.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Sakata |
Organization
Graduate School of Sport Sciences, Waseda University
Division name
Hirose office
Zip code
2020011
Address
3-4-1 Higashifushimi, Nishitokyo city, Tokyo
TEL
042-461-1322
Homepage URL
jun10767@khaki.plala.or.jp
Sponsor or person
Institute
Faculty of Sport Sciences, Waseda University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Sport Sciences, Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2018 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
https://osf.io/5fgcj/overview?view_only=28e1eace3e4343d9a745d11d7ff84a3a
Publication of results
Unpublished
Result
URL related to results and publications
https://osf.io/5fgcj/overview?view_only=28e1eace3e4343d9a745d11d7ff84a3a
Number of participants that the trial has enrolled
246
Results
The intervention group showed a lower incidence of medial elbow injuries compared with the control group.Both groups improved in ball velocity and swing speed, with minimal between group differences.No serious adverse events were observed.
Results date posted
| 2026 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 268 youth baseball players participated.
Age, height, weight, and playing experience were comparable between groups.
Participant flow
A total of 268 participants were randomized into two groups and the 1 year follow-up was completed by 268 participants (intervention: 122, control: 146).
Adverse events
No serious adverse events occurred.
Outcome measures
Primary outcome: Incidence of medial elbow injuries
Secondary outcomes: Ball velocity, swing speed, flexibility, muscle strength, ultrasound findings, and physical performance tests
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036357
