Youth Soccer Header Study

NCT04919707 | Completed

• 4 other identifiers: 2021-0048A536110SMPH/ORTHO&REHAB/ORTHOProtocol Version 4/26/2021
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Keywords

soccer; concussion; sports injuries

Outcome Measures

Primary Outcomes (5)

• Force Strain Kinematic Model Development: Maximum Strain

  High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.

  up to 2 months

• Force Strain Kinematic Model Development: Minimum Principle Strain

  High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.

  up to 2 months

• Force Strain Kinematic Model Development: Maximum Axonal Strain

  High fidelity head kinematics will be acquired during soccer headers under controlled conditions using a custom headband embedded with multi-axis motion sensors. Soccer header force-strain relationships will be compared between age groups, and pre-and post-training session.

  up to 2 months

• Whole brain tractography (fiber tracking) created by MRI scans

  Whole brain tractographs will be created from MRI scans using Diffusion Tensor Imaging.

  up to 2 months

• Brain Injury Probability Map Development: Change in Tissue Strain

  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.

  During the header task session, up to 2 months

Secondary Outcomes (8)

• BRIEF-Monitoring Trail Making Parts A and B Score

  up to 2 months

• Sport Concussion Assessment Tool 5 (SCAT5) Symptom Severity Score

  up to 2 months

• Sport Concussion Assessment Tool 5 (SCAT5) Number of Symptoms

  up to 2 months

• Patient Health Questionnaire (PHQ-9) Score

  up to 2 months

• General Anxiety Disorder Scale-7 (GAD-7) Score

  up to 2 months

Study Arms (2)

Older Adolescent Soccer Players

EXPERIMENTAL

10 male, 10 female soccer players, grades 11-12, age 16-18 Neurocognitive measures, physical measures, header session, MRI

Behavioral: Header Session; Procedure: MRI Session

Younger Adolescent Soccer Players

EXPERIMENTAL

10 male, 10 female soccer players, grades 6-7, age 12-13 Neurocognitive measures, physical measures, header session, MRI

Behavioral: Header Session; Procedure: MRI Session

Interventions

Header Session BEHAVIORAL

Participant fit with commercially available Storelli ExoShield Head Guard that has been fit with head impact sensors; participant completes a set of basic standing header tasks which mimic the types of purposeful heading anticipated to occur in actual play in soccer practice and games.

Older Adolescent Soccer Players; Younger Adolescent Soccer Players

MRI Session PROCEDURE

Scanning will include high resolution T1w imaging for 3-dimensional structural analyses, DTI and resting-state MRI for assessment of structural and functional brain network connectivity, as well as susceptibility-weighted imaging and multicomponent relaxometry to assess for microhemorrhages and myelin damage.

Older Adolescent Soccer Players; Younger Adolescent Soccer Players

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Brain Injuries; Brain Concussion; Athletic Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries, Traumatic; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• M Alison Brooks, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 9, 2021
• Study Start: August 16, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)