UMIN-CTR Clinical Trial

Basic information
Public title	Biomechanics study for identifying postural control characteristics associated with lower limb athletic injury.
Acronym	Biomechanics study for identifying postural control characteristics associated with lower limb athletic injury.
Scientific Title	Biomechanics study for identifying postural control characteristics associated with lower limb athletic injury.
Scientific Title:Acronym	Biomechanics study for identifying postural control characteristics associated with lower limb athletic injury.
Region	Japan

Condition
Condition	Lower extremity ligament injury
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the whole body postural characteristics which could increase the risk of lower limb ligamentous injury in sports
Basic objectives2	Others
Basic objectives -Others	To identify trunk control which induce heel-strike during athletic maneuvers in order to investigate the mechanism of non-contact ACL injury
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Kinematic variables of lower extremity 2.Dynamic variables of lower extremity 3.Electromyographic signals of lower limb muscles 4.Orientation of Trunk 5.Ground reaction force during lab-controlled athletic maneuvers Video filming during handball matches.
Key secondary outcomes

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	Quasi-static lower limb force generation task in sitting position.(A total of 28 trials under three different trunk orientation) Sixty degrees of change of direction following 2 m approach run. (30 trials) Handball match. (1 game)
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	40 years-old >=
Gender	Male and Female
Key inclusion criteria	Experienced athletes (Soccer or Handball)
Key exclusion criteria	1.Persons who had a history of orthopedic injuries within 6 months. 2.Persons did not obtain consent.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Nakata
Organization	Graduate School of Medicine, Osaka University
Division name	Medicine for Sports and Performing Arts
Zip code	565-0871
Address	2-2 Yamadaoka, Center of Medical Innovation and Translational Research Building, Suita, Osaka, 656-0871, Japan
TEL	06-6210-8439
Email	sportssec@hss.osaka-u.ac.jp

Public contact
Name of contact person	1st name Issei Middle name Last name Ogasawara
Organization	Graduate School of Medicine, Osaka University
Division name	Medicine for Sports and Performing Arts
Zip code	565-0871
Address	2-2 Yamadaoka, Center of Medical Innovation and Translational Research Building, Suita, Osaka, 656-0
TEL	06-6210-8439
Homepage URL
Email	sportssec@hss.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine Medicine for Sports and Performing Arts
Institute
Department

Funding Source
Organization	Non.
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 Medical Innovation Osaka University Hospital
Address	Comit 4F, 2-2 Yamadaoka Suita Osaka, 565-0871, Japan
Tel	06-6210-8289
Email	dmi@dmi.med.osaka-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	大阪大学大学院医学系研究科

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 12 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	Preinitiation
Date of protocol fixation	2018 Year 08 Month 13 Day
Date of IRB	2019 Year 09 Month 20 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2023 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 09 Month 12 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037949

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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