UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034103
Receipt number R000037949
Scientific Title Biomechanics study for identifying postural control characteristics associated with lower limb athletic injury.
Date of disclosure of the study information 2018/09/12
Last modified on 2021/09/14 10:49:59

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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 or person

Institute

Osaka University Graduate School of Medicine
Medicine for Sports and Performing Arts

Institute

Department

Personal name



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

Open public recruiting

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

2021 Year 09 Month 14 Day



Link to view the page

Value
https://center6.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