UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034621
Receipt number R000039472
Scientific Title The influence of increase the number of pitches on the elbow joint in college baseball players
Date of disclosure of the study information 2018/10/24
Last modified on 2020/10/27 15:28:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The influence of increase the number of pitches on the elbow joint in college baseball players

Acronym

The influence of increase the number of pitches on the elbow joint

Scientific Title

The influence of increase the number of pitches on the elbow joint in college baseball players

Scientific Title:Acronym

The influence of increase the number of pitches on the elbow joint

Region

Japan


Condition

Condition

Elbow injuries in baseball players

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the influence of increase the number of pitches on the elbow joint.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Elasticity of the forearm flexor pronator muscles

Key secondary outcomes

Distance of the medial elbow joint space
Range of motion of the upper extremity
Muscle strength of the upper extremity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

105 balls throwing with maximal effort (15 balls * 7 innings)

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

18 years-old <=

Age-upper limit

25 years-old >

Gender

Male

Key inclusion criteria

College baseball players

Key exclusion criteria

Individuals who had a history of elbow or shoulder surgery, and upper extremity pain within 6 month.

Target sample size

30


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 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

Coorparative Research office, General Affairs, Akita University Faculty of Medicine

Address

1-1-1, Hondo, Akita

Tel

018-884-6028

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 10 Month 24 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

30

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 11 Month 20 Day

Date of IRB

2018 Year 12 Month 10 Day

Anticipated trial start date

2018 Year 12 Month 20 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



Management information

Registered date

2018 Year 10 Month 24 Day

Last modified on

2020 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039472


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name