Protocol summary

Study aim
Comparison the effectiveness of the extended knee control program versus FIFA +11 on injury incidence density, kinetics, kinematics, and performance variables related to the lower extremity injuries of Iranian soccer players
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 51 patients, for randomization, the procedure available on the following website is used. http://randomizer.org
Settings and conduct
The evaluations before and after the intervention are done in the movement analysis laboratory of Kharazmi University. Protocol implementation sessions are held at the Health Center of Kharazmi University. In this study, the participants are unaware of the randomization process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Football players prone to anterior cruciate ligament injury, no history of injury in the trunk and lower limbs, pain and surgery in the trunk and lower limbs, with a normal body mass index Exclusion criteria: Unwillingness of the subjects to continue participating in the research, surgery on the trunk and lower limbs, defects in the field of vision or abnormality in the vestibular system, a history of ACL rupture in the past, before participating in the current research.
Intervention groups
Extended knee control group, Fifa +11 group
Main outcome variables
Injury rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240417061512N1
Registration date: 2024-06-08, 1403/03/19
Registration timing: prospective

Last update: 2024-06-08, 1403/03/19
Update count: 0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Fatemeh Goli hossein abad
Name of organization / entity
The University of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 21 8832 9220
Email address
fatemehgoliiii7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of the extended knee control program versus FIFA +11 on injury incidence density, kinetics, kinematics, and performance variables related to the lower extremity injuries of Iranian soccer players
Public title
The effectiveness of the extended knee control program versus FIFA +11 on injury incidence density, kinetics, kinematics, and performance variables Iranian soccer players
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Soccer players are prone to ACL Injury
Exclusion criteria:
Soccer players injured in the lower limbs
Age
From 14 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be web-based. Subjects who meet the inclusion criteria were randomly assigned to the Extended Knee Control exercise group, FIFA +11 exercise group, and using the randomization method of the website (Social Psychology Network, Connecticut, USA) www.randomizer.org Control will be divided. Randomization will be simple. Concealment of random allocation using a block random table generated by a computer, where the number 1 will be defined for the knee extension control training group, the number 2 for the FIFA +11 training group, and the number 3 for the control group. Then the random number sequence will be placed in opaque and sealed envelopes. Also, according to the assignment of the group, the treatment will be continued by the researcher. Finally, it will evaluate the results before the interventions and seven months after the interventions.
Blinding (investigator's opinion)
Single blinded
Blinding description
While reading the consent form, the participants were informed about the study groups in a 30-minute session, and without having the right to choose the group, they participated in this study with their consent, so that the names of the patients were entered by someone who was not aware of the identity and physical characteristics of people with Using the site /http://randomizer.org will be randomly divided into three equal groups and each part will be placed separately in sealed envelopes. Then, according to their assigned group, relevant training and exercises are provided to each person. The analyst also examines and compares the changes made before and after 7 months without knowing the hypotheses, study methods and patient characteristics.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Institute of Physical Education and Sports Sciences
Street address
No. 3, fifth alley, Mir Emad St., Ostad Motahari St., Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-10-22, 1402/07/30
Ethics committee reference number
IR/SSRI.REC.1402.215

Health conditions studied

1

Description of health condition studied
Lower limb injuries (susceptible to anterior cruciate ligament injury)
ICD-10 code
T93
ICD-10 code description
Sequelae of injuries of lower limb

Primary outcomes

1

Description
Injury rate
Timepoint
Before and after the intervention
Method of measurement
Injury registration form based on Fuller et al.'s 2006 statement

Secondary outcomes

1

Description
Kinematic variables (Knee Valgus, Knee Flexion in Initial Contact, Hip Adduction in Initial Contact), Kinetic variables (Maximum Vertical Ground Reaction Force, Average Loading Rate, Maximum Knee Abduction Moments) and Performance
Timepoint
Before and after the intervention
Method of measurement
Using 3D motion capture analysis device , Force plate, Triple hop tes

Intervention groups

1

Description
Intervention group: Extended Knee Control programme training group
Category
Prevention

2

Description
Intervention group: FIFA 11+ training group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Football clubs in Tehran
Full name of responsible person
Fatemeh Goli hossein abad
Street address
Mirdamad St., Hessari St., National Sports Complex, Kharazmi University Movement Science Center
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Email
fatemehgoliiii7@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Amir Letafatkar
Street address
Mirdamad St., Hessari St., National Sports Complex, Kharazmi University Movement Science Center
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
This study was conducted by researchers and no institutional funding was received.
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Fatemeh Goli hossein
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports injuries and corrective exercise
Street address
Mirdamad St., Hessari St., National Sports Complex, Kharazmi University Movement Science Center
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Fax
+98 21 2226 9547
Email
fatemehgoliiii7@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Amir Letafatkar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports science
Street address
Mirdamad St., Hessari St., National Sports Complex, Kharazmi University Movement Science Center
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Fax
+98 21 2226 9547
Email
letafatkaramir@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Fatemeh Goli hossein abad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
آسیب شناسی ورزشی و حرکات اصلاحی
Street address
Mirdamad St., Hessari St., National Sports Complex, Kharazmi University Movement Science Center
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Email
fatemehgoliiii7@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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