UMIN-CTR Clinical Trial

Basic information
Public title	Center of pressure (COP) of the carrying and stepping foot in the pitching motion in baseball Elucidation of trajectory and lower limb muscle synergy
Acronym	Center of pressure (COP) of the carrying and stepping foot in the pitching motion in baseball Elucidation of trajectory and lower limb muscle synergy
Scientific Title	Center of pressure (COP) of the carrying and stepping foot in the pitching motion in baseball Elucidation of trajectory and lower limb muscle synergy
Scientific Title:Acronym	Center of pressure (COP) of the carrying and stepping foot in the pitching motion in baseball Elucidation of trajectory and lower limb muscle synergy
Region	Japan

Condition
Condition	healthy baseball player
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to determine the lower limb muscular synergy and COP trajectory of the carrying and stepping feet during the pitching motion in high-level athletes.
Basic objectives2	Others
Basic objectives -Others	Building a foundation for the prevention of pitching disorders
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle synergy: calculated from the muscle activity waveform measured by electromyography COP: Floor reaction force is measured with a floor reaction force meter and COP is calculated.
Key secondary outcomes	The following parameters are calculated using a 3D motion analysis system Kinematic parameters: joint angle, joint angular velocity Kinematic parameters: inter-articular forces, joint torque

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Affixing electrodes for surface electromyography Attaching markers for 3D motion analysis equipment Apply for about 90 minutes on the day of measurement.
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	35 years-old >
Gender	Male
Key inclusion criteria	The level of competition in baseball must be at the college or professional level (either on a college hardball team or in the pros) (Players in a baseball league). The position must be pitcher.
Key exclusion criteria	Pain or disease in the shoulder or elbow joint in the past six months from the date of measurement.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Takehiko Middle name Last name Yamaji
Organization	Gunma University
Division name	Graduate School of Health Sciences, Gunma University, Department of Health Sciences
Zip code	371-8511
Address	3-39-22, Showa-machi, Maebashi, Gunma
TEL	027-220-8948
Email	tyamaji@gunma-u.ac.jp

Public contact
Name of contact person	1st name Yoichi Middle name Last name Kaizu
Organization	Gunma University
Division name	Gunma University Graduate School of Health Sciences Doctoral Course
Zip code	371-8511
Address	3-39-22, Showa-machi, Maebashi, Gunma
TEL	027-220-8948
Homepage URL
Email	h192c001@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Gunma University
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	Department of Clinical Investigation, Gunma University Hospital
Address	3-39-15, Showa-machi, Maebashi, Gunma
Tel	027-220-8740
Email	hitotaisho-ciru@ml.gunma-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 08 Month 01 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
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	Terminated
Date of protocol fixation	2020 Year 07 Month 31 Day
Date of IRB	2020 Year 07 Month 15 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Due to the coronavirus epidemic, it has become difficult to carry out measurements in the laboratory and is now frozen.

Management information
Registered date	2020 Year 06 Month 18 Day
Last modified on	2021 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046598