Viewing Study NCT06638346



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Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06638346
Status: COMPLETED
Last Update Posted: None
First Post: 2024-10-05

Brief Title: Effect of a Shortened FIFA11 Warm-up Program and Sex-specific Footwear on Cutting in Youth Soccer Players
Sponsor: None
Organization: None

Study Overview

Official Title: The Effect of Sex-specific Footwear and Tailored Injury Prevention Program on Cutting Performance
Status: COMPLETED
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This research aims to look at how warm-up programs and types of footwear affect movement patterns that are associated with injury risk during change-of-direction tasks also known as cutting in youth soccer players Specifically this research is conducted in two parts with two different study designs a quasi-randomized controlled trial and a crossover design The main questions it aims to answer are

Part 1 Quasi-RCT How does a shortened FIFA11 warm-up program lasting 3 months affect movement patterns during cutting compared to a standard warm-up program in youth soccer players
Part 2 Crossover design How does female-specific footwear affect movement patterns during cutting compared to unisex footwear in youth female players Secondarily whether specific shoe properties comfort functional traction pressure distribution differ between the two types of footwear

For part 1 of the research

Researchers will compare a shortened FIFA11 with a Brazilian warm-up program standard to see its effect on movement patterns during cutting
Participants will perform their assigned warm-up program twice a week for 3 months 12-weeks
To assess movement patterns participants will perform an unplanned sidestep cutting task captured with markerless cameras before and after the training period

For part 2 only female participants will be involved

Researchers will compare the effects of female-specific soccer cleats designed exclusively for female with unisex soccer cleats on cutting patterns and certain shoe properties
All participants will test both types of footwear and perform an unplanned sidestep task captured with markerless cameras run through a slalom course multiple acceleration and change of directions to test for shoe traction and complete an online survey on shoe comfort and perceived performance
A subset of participants will perform a planned sidestep task with wireless insoles to test for pressure distribution
Detailed Description: With the rise of soccers global prominence injury risks among players remain a concern Deceleration and change of direction maneuvers are frequently employed as an evasive strategy during games However they often contribute to higher risk of non-contact anterior cruciate ligament ACL injuries Sidestep cutting involves planting with one foot and pushing off in the opposite direction Improper movement patterns may increase loads on the planted leg leading to injuries Injury prevention initiatives such as the FIFA11 have been introduced to reduce injury rates but it is unclear whether these programs can correct movement patterns during cutting Moreover the length of these programs often lasting 20 minutes can reduce adherence and hinder their practical implementation in the real-world This results in alternative programs like the Brazilian warm-up to be used instead

In addition females are significantly more at-risk of ACL injuries than males This is often attributed to differences in movement pattern and anatomy Variations in foot anatomy can affect how players interact with footwear which may in turn influence cutting patterns Yet soccer footwear is typically designed using a male foot template ie last resulting in a one-size for all approach for female athletes

In order to address current limitations this study aims to estimate the effect of a shortened FIFA11 and sex-specific footwear on cutting kinematics in youth soccer players This will be done in two parts where part 1 examines two warm-up programs and part 2 examines two types of footwear Ethics approval and informed participants and parental consent as well as assent have been obtained

For part 1 of the study 64 healthy soccer players will be recruited from Soccer Montréal formerly known as Association Régionale de Soccer Concordia ARSC sport study program Soccer Montréal provides soccer sport study programs to high schools for high performance soccer players Soccer Montréal conducts soccer training with pre-established cohorts separated by sex and age Two male and 2 female cohorts will be allocated to either the intervention or control group Male cohorts of similar age groups will be selected and the entire cohort will be randomly allocated using a computer The female cohorts have different age groups and thus allocation to intervention or control will be divided within each cohort following a quasi-randomized fashion During the testing participants are required to perform an unanticipated sidestep maneuver at 45 10 degrees on artificial turf Data will be collected with markerless motion capture systems A total of 7 trials will be captured in each direction only 5 out of 7 will be analyzed

For part 2 of the study female participants from part 1 32 females will test two types of footwear Female-specific and unisex soccer cleats Testing will be done at one time point Female-specific cleats are provided from IDA sports specifically the IDA centra FGAG model Unisex cleats are the Nike Tiempo Legend 10 Academy Proper fit of shoe sizes will be examined manually by the research team prior to testing Kinematic data will be collected using the same unanticipated sidestep task as part 1 Additional testing will include a slalom course to examine functional traction of the shoes Participants will complete an online comfort survey following the slalom course once for each shoe A subset of female participants will also complete a sidestep cutting task with wireless insoles to measure pressure data

Findings of this study will advance knowledge of ACL injury mechanism during cutting tasks aid in the design of more practical injury prevention programs and guide the development of female-specific footwear

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None