UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Compare the effects of comprehensive FIFA injury prevention Program and balance trainings on electromyography, postural control, proprioception and performance variables in 11-14 years old soccer players
Title of the study (Brief title)	comprehensive FIFA injury prevention Program and balance training and 11-14 years old soccer players
Region	Asia(except Japan)

Condition
Condition	sport medicine- pre-post intervention ofcomprehensive FIFA injury prevention Program
Classification by specialty	Orthopedics Rehabilitation medicine Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare the effects of comprehensive FIFA injury prevention Program and balance trainings on electromyography, postural control, proprioception and performance variables in 11-14 years old soccer players
Basic objectives2	Others
Basic objectives -Others	Compare the effects of comprehensive FIFA injury prevention Program and balance trainings on electromyography in 11-14 years old soccer players Compare the effects of comprehensive FIFA injury prevention Program and balance trainings on postural control in 11-14 years old soccer players Compare the effects of comprehensive FIFA injury prevention Program and balance trainings on proprioception in 11-14 years old soccer players Compare the effects of comprehensive FIFA injury prevention Program and balance trainings on performance variables in 11-14 years old soccer players
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	electromyography (pre intervention- post 8weeks interventin in groups)
Key secondary outcomes	postural control(pre intervention- post 8weeks interventin in groups) proprioception (pre intervention- post 8weeks interventin in groups) performance (pre intervention- post 8weeks interventin in groups)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	intervention 1: 8 weeks comprehensive FIFA injury prevention Program (3 time per week) control: without injury prevention program
Interventions/Control_2	intervention 2: 8 weeks balance prevention Program (3 time per week) control: without injury prevention program
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	11 years-old <=
Age-upper limit	14 years-old >=
Gender	Male and Female
Key inclusion criteria	active 11-14 years old soccer players healthy posture
Key exclusion criteria	history of lower extremity injury history of injury prevention program participation
Target sample size	45

Research contact person
Name of lead principal investigator	5
Organization	kharazmi university
Division name	none
Address	Tehran-Iran-mirdamad street, physical education and sport sciences faculty
TEL	00989195394692
Email	letafatkaramir@yahoo.com

Public contact
Name of contact person	Amir Letafatkar
Organization	kharazmi university
Division name	none
Address	Tehran-Iran-mirdamad street, physical education and sport sciences faculty
TEL	00989195394692
Homepage URL
Email	letafatkaramir@yahoo.com

Sponsor
Institute	Kharazmi university faculty of physical education and sport sciences
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 06 Month 29 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 08 Month 03 Day
Anticipated trial start date	2018 Year 09 Month 08 Day
Last follow-up date
Date of closure to data entry	2018 Year 09 Month 15 Day
Date trial data considered complete	2018 Year 12 Month 30 Day
Date analysis concluded	2019 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 08 Day
Last modified on	2019 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035640