UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The examination of prevention effect for reinjury in athlete after anterior cruciate ligament reconstruction(ACLR)
Title of the study (Brief title)	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	Norikazu Hirose
Organization	Waseda University
Division name	Faculty of Sports Sciences
Address	2-579-15 Mikajima,Tokorozawa,Saitama
TEL	042-947-6848
Email	toitsu_hirose@waseda.jp

Public contact
Name of contact person	Yorikatsu Ohmi
Organization	Waseda University
Division name	Graduate School of Sports Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023361