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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000034103 |
Receipt No. | 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 | 2020/03/17 |
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 |
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Condition | |||
Condition | Lower extremity ligament injury | ||
Classification by specialty |
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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 |
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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) |
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Interventions/Control_2 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Experienced athletes (Soccer or Handball)
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Key exclusion criteria | 1.Persons who had a history of orthopedic injuries within 6 months.
2.Persons did not obtain consent. |
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Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |