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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031211
Receipt No. R000035640
Scientific Title 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
Date of disclosure of the study information 2018/06/29
Last modified on 2019/02/09

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Basic information
Public title 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
Acronym comprehensive FIFA injury prevention Program and balance training and 11-14 years old soccer players
Scientific Title 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
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name 5
Organization kharazmi university
Division name none
Zip code
Address Tehran-Iran-mirdamad street, physical education and sport sciences faculty
TEL 00989195394692
Email letafatkaramir@yahoo.com

Public contact
1st name of contact person
1st name
Middle name
Last name Amir Letafatkar
Organization kharazmi university
Division name none
Zip code
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)

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
2018 Year 06 Month 29 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 03 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000035640

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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