ACL injury prevention in preadolescent girl soccer players is study's main purpose.
Design
A number of 40 young healthy female football players will be invited to the laboratory of the Faculty of Physical Education of Bu Ali Sina University in Hamedan. and will be divided into two control and experimental groups with parallel groups. To conceal the random sequence, the method of opaque envelopes with random sequences will be used.
And all the measured factors will be done in two phases before training program and after the training program for both groups.
Settings and conduct
The place of conducting the tests is the laboratory of Bu Ali Sina University in Hamedan.
To conceal the random sequence, the method of closed envelopes with random sequences will be used. And only the data evaluator will be blinded
Participants/Inclusion and exclusion criteria
Only preadolescent females in the range of 10-13 years old will recruit for the study.
Intervention groups
The intervention group performs 11+ kids program for 8 weeks and 2 sessions per week.
The control group performs warm-up routine program.
Main outcome variables
knee flexion, abduction and internal rotation
hip flexion, adduction and internal rotation
trunk flexion, lateral flexion and rotation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220814055680N1
Registration date:2022-11-26, 1401/09/05
Registration timing:retrospective
Last update:2022-11-26, 1401/09/05
Update count:0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Maedeh Taghizadeh Kerman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3523 1441
Email address
maedeh.taghizadeh1988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-12, 1401/07/20
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of FIFA 11+ Kids program on kinematic risk factors for ACL in preadolescent girl soccer players during single leg landing
Public title
11+ Kids exercises on risk factors for ACL
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All of the players involved in football at least 6 months
All of the players should be 10-13 years old
Exclusion criteria:
Neuromuscular disorders
Participation in other sports injury prevention program at past 6 months
Age
From 10 years old to 13 years old
Gender
Female
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
To create a simple random sequence, randomization under web such as graphpad.com and for concealment, allocation concealment will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
For concealment, the method of opaque envelopes with random sequences will be used. Each of the random sequences is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. At the time of starting the registration of the participants, one of the envelopes will be opened based on the order of their arrival and the allocated group of that participant will be revealed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bu-Ali sina university
Street address
No 24, Ahmadi roshan Ave, Pazhuhesh Blvd, Bu ali sina university, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6516738695
Approval date
2021-10-13, 1400/07/21
Ethics committee reference number
IR.BASU.REC.1400.035
Health conditions studied
1
Description of health condition studied
Healthy preadolescent girl soccer players
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Knee angles in sagittal, frontal, and horizontal planes
Timepoint
Pretest and posttest after 8 weeks
Method of measurement
Motion analyze system
2
Description
Hip angles in sagittal , frontal and horizontal planes
Timepoint
Before and after 8 weeks
Method of measurement
Motion capture analysis system
3
Description
Trunk angles in sagittal, frontal and horizontal planes
Timepoint
Before and after 8 weeks
Method of measurement
Motion capture analysis system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 11+ kids training performs for 8 weeks and 2 sessions per week. it includes balance, strength, and jumping training. and there are seven difficulty levels for each exercise
Category
Prevention
2
Description
Control group: Warm up routine program performs for 8 weeks and 2 sessions per week. this includes running, stretching and agility training.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina University
Full name of responsible person
Maedeh Taghizadeh Kerman
Street address
No. 24, Ahmadi Roshan Ave, Pazhuhesh Blvd, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6516738695
Phone
+98 81 3838 1601
Email
maedeh.taghizadeh1988@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Bu Ali sina
Full name of responsible person
Ali Yalfani
Street address
No. 24, Ahmadi Roshan Ave, Pazhuhesh Blvd
City
Hamadan
Province
Hamadan
Postal code
6516738695
Phone
+98 81 3838 1016
Email
maedeh.taghizadeh1988@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
The Universiy of Bu Ali sina
Full name of responsible person
maedeh taghizadeh kerman
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sports injury and corrective exercises
Street address
No 24, Ahmadi Roshan Street, Pazhuhesh Blvd, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6516738695
Phone
+98 51 3523 1441
Email
maedeh.taghizadeh1988@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Bu Ali sina
Full name of responsible person
maedeh taghizadeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport injury
Street address
No 24, Ahmadi Roshan Street, Pazhuhesh blvd,
City
Hamadan
Province
Hamadan
Postal code
6516738695
Phone
+98 51 3523 1441
Email
maedeh.taghizadeh1988@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Bu Ali sina
Full name of responsible person
maedeh taghizadeh kerman
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sports injury
Street address
No 24, Ahmadi Roshan Street, Pazhuhesh BLV, Bu ali sina university, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6516738695
Phone
+98 51 3523 1441
Email
maedeh.taghizadeh1988@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of the points without the names of the participants will be available
When the data will become available and for how long
6 months after the result publication
To whom data/document is available
All of the individuals
Under which criteria data/document could be used
Improvement of the situation of the participants
From where data/document is obtainable
Accessible and available in Bu Ali sina library
What processes are involved for a request to access data/document