UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042035
Receipt number R000047575
Scientific Title On throwing mechanism and injury occurrence in American football
Date of disclosure of the study information 2020/10/07
Last modified on 2023/10/11 13:28:01

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Basic information

Public title

On throwing mechanism and injury occurrence in American football

Acronym

Mechanism of American football throwing and injury

Scientific Title

On throwing mechanism and injury occurrence in American football

Scientific Title:Acronym

Mechanism of American football throwing and injury

Region

Japan


Condition

Condition

Healthy general population

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the throwing mechanism in detail and to clarify the difference from the throwing action in baseball in order to construct a preventive measure for upper limb disorders of American football quarterback.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

arm stress

Key secondary outcomes

arm slot
shoulder lotation
arm speed
distraction force
finger tip velocity


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1) Those who are capable of regular pitching in baseball and American football.
2) Those who can perform various measurements.
3) Those that consent form by the free will of the person was provided after enough understanding after having received explanation on participation of this study.

Key exclusion criteria

1) The participant who have difficulty in continuing measurement due to the progression of some kinds of diseases.
2) Those who are judged by the doctors to stop the measurement.
3) Those who were judged unsuitable as a participant by the doctors.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Muroi

Organization

St. Marianna University School of Medicine

Division name

Department of Sports Medicine

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, JAPAN

TEL

044-977-8111

Email

ryota.muroi@marianna-u.ac.jp


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Muroi

Organization

St. Marianna University School of Medicine

Division name

Department of Sports Medicine

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, JAPAN

TEL

044-977-8111

Homepage URL


Email

ryota.muroi@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Sports Medicine,
St. Marianna University School of Medicine.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School & Research Promotion Division, St. Marianna University School of Medicine

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, JAPAN

Tel

044-977-8111

Email

k-shienbu.mail@marianna-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

2020 Year 10 Month 07 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

5

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

No longer recruiting

Date of protocol fixation

2020 Year 08 Month 27 Day

Date of IRB

2020 Year 09 Month 04 Day

Anticipated trial start date

2020 Year 09 Month 09 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information

The design of this study is a case-series comparative test of throwing motions of a baseball and American football.Evaluation is measured by attaching a sleeve with a sensor to the elbow joint.The subjects are experienced baseball and American football players.The measurement period is only one day.


Management information

Registered date

2020 Year 10 Month 07 Day

Last modified on

2023 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047575


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name