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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020297
Receipt No. 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

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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
Email 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
Email yorikatsu.ohmi@fuji.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023361

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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