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临床试验/NCT06638346
NCT06638346已完成不适用

The Effect of Sex-specific Footwear and Tailored Injury Prevention Program on Cutting Performance

McGill University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
[Study Part 1: Warm-up programs]: Joint kinematics of lower extremity and trunk

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

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.

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

  • [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 Part 2: Footwear]: Impulse plantar pressure(Baseline (one time point))
  • [Study Part 2: Footwear]: Performance rating: Perceived traction suitability(Baseline (one time point))
  • [Study Part 2: Footwear]: Performance rating: Overall performance(Baseline (one time point))
  • [Study Part 2: Footwear]: Comfort rating: Overall comfort(Baseline (one time point))
  • [Study Part 2: Footwear]: Comfort rating: Overall shoe fit(Baseline (one time point))
  • [Study Part 2: Footwear]: Comfort rating: Overall cushioning(Baseline (one time point))
  • [Study Part 2: Footwear]: Comfort rating: Overall shoe weight(Baseline (one time point))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Chen

PhD Candidate

McGill University

研究点 (2)

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