UMIN-CTR Clinical Trial

Basic information
Public title	Comparing the Effect of Neuromuscular Training with and without Feedback on Coordination Pattern, Coordination Variability (Joint Coupling Patterns of Trunk, Lumbopelvic, Hip, Knee) and Muscle Chain Activation Active Subjects Prone to Injury
Acronym	Neuromuscular Training with and without Feedback on Coordination Pattern, Coordination Variability and Muscle Chain Activation
Scientific Title	Comparing the Effect of Neuromuscular Training with and without Feedback on Coordination Pattern, Coordination Variability (Joint Coupling Patterns of Trunk, Lumbopelvic, Hip, Knee) and Muscle Chain Activation Active Subjects Prone to Injury
Scientific Title:Acronym	Neuromuscular Training with and without Feedback on Coordination Pattern, Coordination Variability and Muscle Chain Activation
Region	Asia(except Japan)

Condition
Condition	pre post interventoin
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to comparing the effect of two types of neuromuscular training with and without feedback on coordination pattern, coordination variability (joint coupling patterns of trunk, lumbopelvic, hip, knee) and muscle chain (front and back functional lines, the functional line which includes muscles, adductor longus, rectus abdominis, pectoralis major, vastus lateralis, gluteus maximus, latissimus dorsi) activaction in active subjects prone to injury
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	muscle activation
Key secondary outcomes	coordination pattern, coordination variability (joint coupling patterns of trunk, lumbopelvic, hip, knee)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Neuromuscular Training with Feedback/placebo
Interventions/Control_2	Neuromuscular Training/placebo
Interventions/Control_3	continued its regular team schedule/control
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	26 years-old >=
Gender	Male
Key inclusion criteria	score of 6 and greater than in LESS test, Existence of knee dynamic valgus of more than 10 degrees in the frontal plane (abduction) during the single-leg squat test, No history of injury to the trunk and lower extremitie, The absence of pain and surgery in the trunk and lower extremities, normal body mass index (19 to 25).
Key exclusion criteria	Unwillingness of subjects to continue research, Defect in the field of vision or anomaly in the Vestibular system, Injury during training,
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Middle name Last name Amir Letafatkar
Organization	Kharazmi University
Division name	Department of Biomechanics and Sport injuries
Zip code
Address	Kharazmi University, Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport complex Tehran, Iran
TEL	+989195394692
Email	letafatkaramir@yahoo.com

Public contact
Name of contact person	1st name Middle name Last name Bahram Sheikhi
Organization	Kharazmi University
Division name	Department of Biomechanics and Sport injuries
Zip code
Address	Kharazmi University, Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport complex Tehran, Iran
TEL	+989376569397
Homepage URL
Email	sheikhibahram@gmail.com

Sponsor
Institute	Kharazmi University
Institute
Department

Funding Source
Organization	Kharazmi 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	2019 Year 05 Month 08 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	2018 Year 11 Month 30 Day
Date of IRB	2018 Year 12 Month 05 Day
Anticipated trial start date	2018 Year 12 Month 12 Day
Last follow-up date	2019 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 28 Day
Last modified on	2019 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039949