UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033828 |
|---|---|
| Receipt number | R000038434 |
| Scientific Title | Changes on standing of forearm function and performance of university semi-hard baseball players. |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2019/02/21 17:44:32 |
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Basic information
Public title
Changes on standing of forearm function and performance of university semi-hard baseball players.
Acronym
Changes on standing of forearm function and performance of university semi-hard baseball players.
Scientific Title
Changes on standing of forearm function and performance of university semi-hard baseball players.
Scientific Title:Acronym
Changes on standing of forearm function and performance of university semi-hard baseball players.
Region
| Japan |
Condition
Condition
University semi-hard baseball players.
The shoulder joint and the elbow joint without pain, the person that can best pitching.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Throwing elbow injury is said to be an important cause of valgus stress applied to the elbow joint. Prevention of throwing elbow injury requires reduction of valgus stress. Previous studies show that loading is applied to the forearm muscle during throwing motion and it is considered important for prevention of throwing elbow injury. It is aimed to discover deterioration of forearm function and performance deterioration before and after the season, and to help conditioning and prevention of disability.
Basic objectives2
Others
Basic objectives -Others
Confirm temporal changes in physical function and performance.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
I use the speed of pitched ball as an evaluation index. I measure twice before and after the league games. And confirm the change of 2 points.
Key secondary outcomes
I use forearm function as evaluation item. I measure five items of grip strength, pinch force, muscle tightness, ulnar carpi flexor muscle strength, muscle hardness. Measure twice before and after the league game.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
With a period of about 2 months, measure the 7 items twice.
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
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
University semi-hard baseball players
Capture all players regardless of position
Key exclusion criteria
Currently, there are orthopedic disease or pain, such as the shoulder, elbow, what our best pitching is difficult.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Sakamoto |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8972
msaka@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shota Suzuki |
Organization
Gunma university
Division name
Graduate School of Health Sciences
Zip code
Address
3-39-22 Showa, Maebashi, Gunma
TEL
09046697086
Homepage URL
h171c012@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Culture,Sports,Science and Technology.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
群馬大学医学部昭和キャンパス(群馬県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038434
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| Registered date | File name |
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