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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000031838 |
Receipt No. | 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 | 2020/09/22 |
Basic information | ||
Public title | Prevention for throwing injuries
-To be compatible with both the prevention and performance- |
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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- |
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Scientific Title:Acronym | TO investigate the effect of prevention program for throwing medial elbow injury | |
Region |
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Condition | ||
Condition | throwing medial elbow injury | |
Classification by specialty |
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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 | Cross-over |
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 |
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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 |
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Interventions/Control_2 | Control group
usual warm up program 10 minutes per 1 time, 2 times per a week, during 1 year |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 1000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Faculty of Sport Sciences, Waseda University |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036357 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |