Clinical trial NCT04919707: Youth Soccer Header Study
Official title: Evaluation of Head Kinematics, Force-strain Models, and Correlation of MRI Markers With Neurocognitive Testing in Youth Soccer Heading
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Keywords: soccer
concussion
sports injuries
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks. 40 youth soccer players will be recruited from the Madison, WI area and can expect to be on study for 2 months.

Detailed description: Despite the large popularity of soccer worldwide and in the US, the majority of research on sport-related head impacts has been concentrated in male American football players using head-impact measurement sensors in instrumented football helmets. The limited research in soccer players likewise has focused on males, particularly those playing at an elite level, such as collegiate or professional. Unfortunately there is a paucity of data on youth soccer athletes in regards to how these younger players actually head the ball and what forces they experience. Measurement of head impacts is essential to further understanding the potential risks associated with heading in youth soccer, and to further inform rule or policy changes that limit head impact exposure in these younger age groups.

Specific Aim: Establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks.

In this study, age-and sex-specific force strain models will be validated using a study of soccer headers under controlled conditions. Youth soccer players in 6th-12th grade will be recruited to participate in a header training session while wearing motion sensor headbands. All children will undergo MRI scanning and baseline assessment of neurocognitive function, psychological health, and academic aptitude and performance. Participant-specific finite element models will be created from MRI scans, and principle tissue strains will be determined based on head motion profiles during soccer headers and compared between age- and sex-specific groups.

High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. MRI scans will be obtained in all participants, and individualized and population averaged (to reduce computational burden), whole brain tractographs will be created. New participants-specific finite element models will be generated using geometry-adaptive mesh morphing techniques to match the head morphology of each subject using a baseline FE head model (to reduce model development time). The linear and angular acceleration histories obtained from the pre- and post-training soccer heading tasks will be applied directly to the FE models to simulate the head motion of each participant. The principal strains will be determined for each heading task, and brain injury probability maps will be generated based on the resulting tissue strain. Brain injury risk will be assessed through the incorporation of a cellular injury criterion embedded into the finite element simulations, with smaller strains correlating with lower injury risk. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session. This analysis will provide insight into the effect of age and training on improving heading techniques and reducing the risk of injury.

Eligibility criteria: Inclusion Criteria:

* Age 12-13 or 16-18 years
* Currently participating in organized interscholastic or club soccer
* No active musculoskeletal injury that limits full participation in soccer activities

Exclusion Criteria:

* 14-15 year old are not eligible
* History of prior concussion or other head injury
* History of prior cervical spine injury
* Potential participants who can not participate in the MRI scan will be excluded
* Pregnancy or possible pregnancy (one reason for MRI exclusion)

Primary outcomes:
measure: Force Strain Kinematic Model Development: Maximum Strain
timeFrame: up to 2 months
measure: Force Strain Kinematic Model Development: Minimum Principle Strain
timeFrame: up to 2 months
measure: Force Strain Kinematic Model Development: Maximum Axonal Strain
timeFrame: up to 2 months
measure: Whole brain tractography (fiber tracking) created by MRI scans
timeFrame: up to 2 months
measure: Brain Injury Probability Map Development: Change in Tissue Strain
timeFrame: During the header task session, up to 2 months
Secondary outcomes:
measure: BRIEF-Monitoring Trail Making Parts A and B Score
timeFrame: up to 2 months
measure: Sport Concussion Assessment Tool 5 (SCAT5) Symptom Severity Score
timeFrame: up to 2 months
measure: Sport Concussion Assessment Tool 5 (SCAT5) Number of Symptoms
timeFrame: up to 2 months
measure: Patient Health Questionnaire (PHQ-9) Score
timeFrame: up to 2 months
measure: General Anxiety Disorder Scale-7 (GAD-7) Score
timeFrame: up to 2 months
measure: Pediatric Quality of Life Inventory (PEDS-QL) Score
timeFrame: up to 2 months
measure: Deep Cervical Flexor Endurance Test (DCFET)
timeFrame: up to 2 months
measure: Y Balance Test (YBT)
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: M Alison Brooks, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: