---
title: Effect of a Shortened FIFA11+ Warm-up Program and Sex-specific Footwear on Cutting in Youth Soccer Players
nct_id: NCT06638346
overall_status: COMPLETED
phase: NA
sponsor: McGill University
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06638346.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06638346"
ct_last_update_post_date: 2025-12-19
last_seen_at: "2026-05-12T07:00:57.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of a Shortened FIFA11+ Warm-up Program and Sex-specific Footwear on Cutting in Youth Soccer Players

**Official Title:** The Effect of Sex-specific Footwear and Tailored Injury Prevention Program on Cutting Performance

**NCT ID:** [NCT06638346](https://clinicaltrials.gov/study/NCT06638346)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** McGill University
- **Collaborators:** Natural Sciences and Engineering Research Council, Canada, IDA sports, Soccer Montréal
- **Conditions:** Healthy
- **Start Date:** 2024-01-29
- **Completion Date:** 2024-05-22
- **CT.gov Last Update:** 2025-12-19

## 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.

## Detailed Description

With the rise of soccer's 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 (i.e. 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 FG/AG 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.

## Eligibility

- **Minimum age:** 13 Years
- **Maximum age:** 17 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Arms

- **[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.
- **[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.

## 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.
- **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.

## Primary Outcomes

- **[Study Part 1: Warm-up programs]: Joint kinematics of lower extremity and trunk** _(time frame: At baseline)_ — 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.
- **[Study Part 1: Warm-up programs]: Joint kinematics of lower extremity and trunk** _(time frame: After the 12-week intervention)_ — 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.
- **[Study Part 2: Footwear]: Joint kinematics of lower extremity and trunk** _(time frame: Baseline (one time point))_ — 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.

## Secondary Outcomes

- **[Study Part 2: Footwear]: Slalom course running time** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Hindfoot mediolateral plantar pressure ratios** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Forefoot mediolateral plantar pressure ratios** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Peak plantar pressure** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Mean plantar pressure** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Impulse plantar pressure** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Performance rating: Perceived traction suitability** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Performance rating: Overall performance** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Comfort rating: Overall comfort** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Comfort rating: Overall shoe fit** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Comfort rating: Overall cushioning** _(time frame: Baseline (one time point))_
- **[Study Part 2: Footwear]: Comfort rating: Overall shoe weight** _(time frame: Baseline (one time point))_

## Locations (1)

- McGill University, Montreal, Quebec, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mcgill university|montreal|quebec|canada` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06638346*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*