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
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
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
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
