UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032129 |
|---|---|
| Receipt number | R000036656 |
| Scientific Title | Elasticity of the forearm flexor pronator muscles in youth baseball players with elbow injuries: Evaluation using strain elastography |
| Date of disclosure of the study information | 2018/04/06 |
| Last modified on | 2019/04/09 17:43:00 |
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Basic information
Public title
Elasticity of the forearm flexor pronator muscles in youth baseball players with elbow injuries: Evaluation using strain elastography
Acronym
Elasticity of the forearm flexor pronator muscles in youth baseball players
Scientific Title
Elasticity of the forearm flexor pronator muscles in youth baseball players with elbow injuries: Evaluation using strain elastography
Scientific Title:Acronym
Elasticity of the forearm flexor pronator muscles in youth baseball players
Region
| Japan |
Condition
Condition
Elbow injuries in youth baseball players
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the elasticity of the forearm flexor pronator muscles and elbow injuries in youth baseball players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elasticity of the forearm flexor pronator muscles using ultrasound elastography.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male
Key inclusion criteria
Youth baseball players in local baseball club.
Key exclusion criteria
Individuals who had a history of elbow surgery or shoulder pain.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Saito |
Organization
Akita University Graduate School of Health Sciences
Division name
Department of Physical Therapy
Zip code
010-8543
Address
1-1-1, Hondo, Akita
TEL
018-884-6552
ptsaito@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Saito |
Organization
Akita University Graduate School of Health Sciences
Division name
Department of Physical Therapy
Zip code
010-8543
Address
1-1-1, Hondo, Akita
TEL
018-884-6552
Homepage URL
ptsaito@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethics Committee of Akita University Graduate School of Health Sciences
Address
1-1-1, Hondo, Akita
Tel
018-884-6029
soken@hos.akita-u.ac.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 | 04 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.jshoulderelbow.org/article/S1058-2746(18)30376-8/abstract
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
197
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
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under examination
Management information
Registered date
| 2018 | Year | 04 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036656
