Effect of a Shortened FIFA11+ Warm-up Program and Sex-specific Footwear on Cutting in Youth Soccer Players

NCT06638346 | Completed

• 2 other identifiers: A12-M61-23B (23-10-088)RGPIN-2018-06525
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 sex and 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.

Conditions

Healthy

Keywords

sidestep cutting; markerless motion capture system; injury prevention program; female-specific footwear; kinematics; shortened FIFA11+; youth soccer players

Outcome Measures

Primary Outcomes (3)

• [Study Part 1: Warm-up programs]: Joint kinematics of lower extremity and trunk

  Kinematic data will be captured for both intervention and control group using markerless motion capture system. Joint angles will be assessed throughout the cutting phase from pre-contact (100ms prior to foot strike) to foot-off of the planted leg. Specifically, joint kinematics will include: hip flexion/extension, hip abduction/adduction, hip internal/external rotation, knee flexion/extension, knee abduction/adduction, ankle dorsiflexion/plantarflexion, ankle inversion/eversion, trunk flexion/extension, trunk side flexion and trunk rotation. Principal component analysis will be used to analyze the whole angle waveform throughout cutting. Therefore, each kinematic outcome measure will be expressed as angle PC-scores which measures the degree of correspondence between angle waveform and principal components (PCs). PCs will captures variability features of angle waveform data such as amplitude, angle differences, etc.

  At baseline

• [Study Part 1: Warm-up programs]: Joint kinematics of lower extremity and trunk

  Kinematic data will be captured for both intervention and control group using markerless motion capture system. Joint angles will be assessed throughout the cutting phase from pre-contact (100ms prior to foot strike) to foot-off of the planted leg. Specifically, joint kinematics will include: hip flexion/extension, hip abduction/adduction, hip internal/external rotation, knee flexion/extension, knee abduction/adduction, ankle dorsiflexion/plantarflexion, ankle inversion/eversion, trunk flexion/extension, trunk side flexion and trunk rotation. Principal component analysis will be used to analyze the whole angle waveform throughout cutting. Therefore, each kinematic outcome measure will be expressed as angle PC-scores which measures the degree of correspondence between angle waveform and principal components (PCs). PCs will captures variability features of angle waveform data such as amplitude, angle differences, etc.

  After the 12-week intervention

• [Study Part 2: Footwear]: Joint kinematics of lower extremity and trunk

  Kinematic data will be collected for female-specific footwear and unisex footwear using markerless motion capture system. Joint angles will be assessed throughout the cutting phase from pre-contact (100ms prior to foot strike) to foot-off of the planted leg. Specifically, joint kinematics will include: hip flexion/extension, hip abduction/adduction, hip internal/external rotation, knee flexion/extension, knee abduction/adduction, ankle dorsiflexion/plantarflexion, ankle inversion/eversion, trunk flexion/extension, trunk side flexion and trunk rotation. Principal component analysis will be used to analyze the whole angle waveform throughout cutting. Therefore, each kinematic outcome measure will be expressed as angle PC-scores which measures the degree of correspondence between angle waveform and principal components (PCs). PCs will capture variability features of angle waveform data such as amplitude, angle differences, etc.

  Baseline (one time point)

Secondary Outcomes (12)

• [Study Part 2: Footwear]: Slalom course running time

  Baseline (one time point)

• [Study Part 2: Footwear]: Hindfoot mediolateral plantar pressure ratios

  Baseline (one time point)

• [Study Part 2: Footwear]: Forefoot mediolateral plantar pressure ratios

  Baseline (one time point)

• [Study Part 2: Footwear]: Peak plantar pressure

  Baseline (one time point)

• [Study Part 2: Footwear]: Mean plantar pressure

  Baseline (one time point)

Study Arms (2)

[Part 1 of study]: Shortened FIFA 11+ Intervention Group

EXPERIMENTAL

The intervention group will complete a shortened FIFA11+ pre-activation training, incorporating 5 exercises from FIFA11+. The program will be performed twice a week for 12 weeks. The program lasts approximately 7 minutes.

Other: Shortened FIFA 11+ warm-up exercise program

[Part 1 study]: Control Group (Standard warm-up)

ACTIVE COMPARATOR

The control group will engage in a Brazilian warm-up, lasting approximately 7 minutes, 2 times a week for 3 months. Brazilian warm-ups are typically performed the usual warm-up routine at Soccer Montréal. A standardized version of the warm-up will be given so that all participants in the control group will undergo the same program.

Other: Brazilian warm-up exercise program

Interventions

Shortened FIFA 11+ warm-up exercise program OTHER

The shortened FIFA11+ incorporates 5 exercises from the original FIFA11+ part 2 and 3: Sideways bench, single-leg stance, squats, jumping and plant and cut (refer to FIFA 11+ manual). All exercises, except plant and cut, have three levels of difficulty. Difficulty progression will follow FIFA11+ guideline option C where all players progress to the next level of all exercises after 3 or 4 weeks. This program is done on artificial turf. Coaches will be trained on FIFA guidelines by the primary investigator and provided with explanatory placards and the FIFA 11+ manual. The primary investigator will conduct checks twice a week with the coaches to address any questions and review the program. Only the shortened FIFA11+ group will receive verbal feedback as per FIFA11+ guidelines.

[Part 1 of study]: Shortened FIFA 11+ Intervention Group

Brazilian warm-up exercise program OTHER

The control group engages in a Brazilian warm-up. The warm-up consists of exercises performed in standing and while running including the following: * Performed in standing: Circular Arms (20-30 sec total), Opening and closing of the hips (20-30 sec total). * Performed while running back and forth on the field: Jogging (2 times), high kicks (2 times), glute kicks (2 times) * Performed while running forward (exercise), then small jog back without performing the exercise: hand-to-heel touches (2 times), knee and heel touches (2 times each side), side leg swings (2 times) and progressive sprint 80-90% speed (2 times). Coaches will supervise the session but will not be allowed to give verbal feedback. This program is done on artificial turf.

Also known as: Usual soccer warm-up, Standard warm-up, Typical warm-up

[Part 1 study]: Control Group (Standard warm-up)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Soccer players
• Enrolled in Association Régionale de Soccer Concordia (ARSC), now known as Soccer Montréal, soccer sport study program.
• Age between 13-17 years old.

You may not qualify if:

• Any history of major lower limb or back injuries (e.g., torn ACL, herniated vertebrae)
• History of any lower extremity surgery
• Current medical/neurological condition preventing cutting maneuver or training.

Sponsors & Collaborators

• McGill University: lead
• IDA sports: collaborator
• Soccer Montréal: collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

McGill University

Montreal, Quebec, H4A 1J6, Canada

Location

Related Publications (9)

• Sterzing, T., Müller, C., Hennig, E. M., & Milani, T. L. (2009). Actual and perceived running performance in soccer shoes: A series of eight studies. Footwear Science, 1(1), 5-17. https://doi-org.proxy3.library.mcgill.ca/10.1080/19424280902915350

  BACKGROUND

• Lam WK, Ng WX, Kong PW. Influence of shoe midsole hardness on plantar pressure distribution in four basketball-related movements. Res Sports Med. 2017 Jan-Mar;25(1):37-47. doi: 10.1080/15438627.2016.1258643. Epub 2016 Nov 21.

  PMID: 27868427 BACKGROUND

• Kanko RM, Laende E, Selbie WS, Deluzio KJ. Inter-session repeatability of markerless motion capture gait kinematics. J Biomech. 2021 May 24;121:110422. doi: 10.1016/j.jbiomech.2021.110422. Epub 2021 Apr 8.

  PMID: 33873117 BACKGROUND

• Ford, K. R., Nguyen, A. D., Westbrook, A. E., Mulrey, C. R., & Taylor, J. B. (2017). Footwear-induced changes in ankle biomechanics during unanticipated side-step cutting in female soccer players. Footwear Science, 9(sup1), S68-S70. https://doi-org.proxy3.library.mcgill.ca/10.1080/19424280.2017.1314343

  BACKGROUND

• O'Brien J, Young W, Finch CF. The use and modification of injury prevention exercises by professional youth soccer teams. Scand J Med Sci Sports. 2017 Nov;27(11):1337-1346. doi: 10.1111/sms.12756. Epub 2016 Oct 7.

  PMID: 27714907 BACKGROUND

• Soligard T, Nilstad A, Steffen K, Myklebust G, Holme I, Dvorak J, Bahr R, Andersen TE. Compliance with a comprehensive warm-up programme to prevent injuries in youth football. Br J Sports Med. 2010 Sep;44(11):787-93. doi: 10.1136/bjsm.2009.070672. Epub 2010 Jun 15.

  PMID: 20551159 BACKGROUND

• Agel J, Rockwood T, Klossner D. Collegiate ACL Injury Rates Across 15 Sports: National Collegiate Athletic Association Injury Surveillance System Data Update (2004-2005 Through 2012-2013). Clin J Sport Med. 2016 Nov;26(6):518-523. doi: 10.1097/JSM.0000000000000290.

  PMID: 27315457 BACKGROUND

• Carlson VR, Sheehan FT, Boden BP. Video Analysis of Anterior Cruciate Ligament (ACL) Injuries: A Systematic Review. JBJS Rev. 2016 Nov 29;4(11):e5. doi: 10.2106/JBJS.RVW.15.00116.

  PMID: 27922985 BACKGROUND

• Wunderlich RE, Cavanagh PR. Gender differences in adult foot shape: implications for shoe design. Med Sci Sports Exerc. 2001 Apr;33(4):605-11. doi: 10.1097/00005768-200104000-00015.

  PMID: 11283437 BACKGROUND

Related Links

• FIFA11+ Manual

Study Officials

• Shawn Robbins, Associate Professor, PhD

  McGill University

  STUDY DIRECTOR

• Karen Chen, PhD Candidate

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All the participants are within the same soccer organization and therefore complete masking of participants to group allocation is not possible. Coaches will be aware of allocations given that they will need to supervise the groups and give appropriate feedback if required. The primary investigator will be implicated in all aspects of the study (recruitment, data collection, supervision of training sessions, analysis) and thus will be aware of group allocations. Other research members that will help with data collection procedures will not be aware of group allocations.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: \[Part1: Warm-up intervention\]: It will consist of a longitudinal and prospective study conducted as a 2-group parallel quasi-randomized controlled trial with a 1:1 allocation and two time points (baseline, after 12-weeks). Both groups will complete a 12-week warm-up program. Group allocation will be done in a quasi-randomized fashion (see study detailed description). \[Part2: Footwear study\]: It will consist of a prospective, crossover design at one time point. All female participants will test both types of footwear (female-specific and unisex).

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 15, 2024
• Study Start: January 29, 2024
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available following publication. No end date
• Access Criteria: Our study data will be published in an open-access format (available to anyone who wishes to access the information), while protecting participant anonymity. It will encompass only de-identified biomechanical and demographic data, which will be shared via a dedicated repository on the McGill IHRG (Ice Hockey Research Group) server.

Locations

CA (1)