UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dual-task on kinematics and kinetics during single-leg landing after anterior cruciate ligament reconstruction.
Title of the study (Brief title)	Effect of dual-task on kinematics and kinetics during single-leg landing after anterior cruciate ligament reconstruction.
Region	Japan

Condition
Condition	anterior cruciate ligament.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We observe effects of dual-task on kinematics, kinetics and EMG during single-leg landing after anterior cruciate ligament reconstruction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	kinetics, kinematics, EMG, ground reaction force
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	observation at one day.
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	players who operated on anterior cruciate ligament reconstruction(ACLR) before 8 months.
Key exclusion criteria	players who operated on another injury. players who operated on another ACL.
Target sample size	20

Research contact person
Name of lead principal investigator	Masashi Yamazaki
Organization	Tsukuba University
Division name	Orthopedics
Address	Amakubo2-1-1 tsukuba city Ibaraki Japan
TEL	029-853-3219
Email	masashiy@md.tsukuba.ac.jp

Public contact
Name of contact person	Masaya Kajiwara
Organization	University of Tsukuba Hospital
Division name	Orthopedics
Address	Amakubo2-1-1 tsukuba city ibaraki Japan
TEL	029-853-3219
Homepage URL
Email	m.kajiwara24@gmail.com

Sponsor
Institute	Tsukuba University Orthopedics
Institute
Department

Funding Source
Organization	Tsukuba University Orthopedics
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	2017 Year 01 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 25 Day
Anticipated trial start date	2017 Year 01 Month 25 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	2017 Year 01 Month 24 Day
Last modified on	2017 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029675