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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000032129
Receipt No. 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

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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
Email 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
Email ptsaito@hs.akita-u.ac.jp

Sponsor
Institute Akita University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036656

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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