UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020297 |
|---|---|
| Receipt number | R000023361 |
| Scientific Title | The examination of prevention effect for reinjury in athlete after anterior cruciate ligament reconstruction(ACLR) |
| Date of disclosure of the study information | 2015/12/21 |
| Last modified on | 2017/01/13 17:21:35 |
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Basic information
Public title
The examination of prevention effect for reinjury in athlete after anterior cruciate ligament reconstruction(ACLR)
Acronym
The examination of prevention effect for reinjury in athlete after anterior cruciate ligament reconstruction(ACLR)
Scientific Title
The examination of prevention effect for reinjury in athlete after anterior cruciate ligament reconstruction(ACLR)
Scientific Title:Acronym
The examination of prevention effect for reinjury in athlete after anterior cruciate ligament reconstruction(ACLR)
Region
| Japan |
Condition
Condition
anterior cruciate ligament injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prevention effect for reinjury in athlete after ACLR
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Single leg landing
Key secondary outcomes
muscle test(knee extention,flexion,hip abduction,hip external rotation)
Star Excursion Balance Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
athlete after ACLR finished prevention program
Interventions/Control_2
healthy athlete,no histry of knee injury
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
| 16 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
anterior cruciate ligament injury
Key exclusion criteria
meniscus injury
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikazu Hirose |
Organization
Waseda University
Division name
Faculty of Sports Sciences
Zip code
Address
2-579-15 Mikajima,Tokorozawa,Saitama
TEL
042-947-6848
toitsu_hirose@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yorikatsu Ohmi |
Organization
Waseda University
Division name
Graduate School of Sports Sciences
Zip code
Address
2-7-5 Higashifushimi,Nishitokyo,Tokyo
TEL
042-461-1322
Homepage URL
yorikatsu.ohmi@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda 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
Address
Tel
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
| 2015 | Year | 12 | Month | 21 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 21 | Day |
Last modified on
| 2017 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023361
