Clinical trial NCT04908930: Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3
Official title: Community-Engaged Sport Safety - Aim 1 and Aim 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injury
Sport Injury
Keywords: Sport Safety
Youth Football
Head Impact Exposure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-06-01
Enrollment: 106
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All interested football players on the 2 teams will be enrolled; will be randomly selected for instrumentation with head impact sensors using a random numbers table. Athletes on these teams will follow their coach prescribed practice structure.

Two additional youth football teams at the middle school level will be recruited to pilot test the intervention developed in this study. All interested athletes on these teams will be enrolled; will be randomly selected for instrumentation with head impact sensors using a random numbers table.

Enrolled athletes will wear head impact sensors embedded in a custom mouthpiece that will be used to collect head impact exposure in conjunction with on-field video data for the season.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Two middle school (ages 11-14) football teams will be in Aim 1 of this study. All interested athletes on these teams will be invited to voluntarily participate in biomechanical data collection; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. In aim 3, two youth football teams at the middle school level will be recruited to pilot an intervention developed this study. The football coaches of each team will be prospectively recruited and enrolled. All interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. Baseline and post-season neurocognitive data will be collected.

Detailed description: This study hypothesizes that (a) determinants at the individual (athlete), interpersonal (team \& coach), and community levels (built \& social environment) of the social ecological model may be identified and targeted to reduce head impact exposure in youth football practices, and (b) an evidence-based strategy to reduce head impact exposure in practices may be developed and pilot tested using a community-engaged approach.

Eligibility criteria: Inclusion Criteria:

* All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months.

Exclusion Criteria:

* Athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).

Primary outcomes:
measure: Number of Head Impacts
timeFrame: Month 3
measure: Number of Impacts Per Player Per Minute
timeFrame: Month 3
measure: Mean Number of Impacts Per Athlete Per Practice
timeFrame: Month 3
measure: 95th Percentile Number of Impacts Per Athlete Per Practice
timeFrame: Month 3
measure: Median Linear Acceleration (g)
timeFrame: Month 3
measure: Median Rotational Acceleration
timeFrame: Month 3
measure: Median Rotational Velocity
timeFrame: Month 3
measure: 95th Percentile Linear Acceleration (g)
timeFrame: Month 3
measure: 95th Percentile Rotational Acceleration
timeFrame: Month 3
measure: 95th Percentile Rotational Velocity
timeFrame: Month 3
Secondary outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Month 3
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Month 3
measure: Percentage of Practices the Intervention Was Implemented as Prescribed
timeFrame: Month 3
measure: Number Changes to the Intervention
timeFrame: Month 3
measure: Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing
timeFrame: Baseline
measure: Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing
timeFrame: Baseline
measure: (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score
timeFrame: Baseline
measure: (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score
timeFrame: Baseline
measure: (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score
timeFrame: Baseline
measure: Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score
timeFrame: Baseline
measure: Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score
timeFrame: Month 3
measure: NIH Toolbox List Sorting Working Memory Test Score
timeFrame: Baseline
measure: NIH Toolbox List Sorting Working Memory Test Score
timeFrame: Month 3
measure: NIH Toolbox Picture Vocabulary Test Score
timeFrame: Baseline
measure: NIH Toolbox Picture Sequence Memory Test Score
timeFrame: Baseline and month 3
measure: NIH Toolbox Picture Vocabulary Test Score
timeFrame: Month 3
measure: Rey Auditory Verbal Learning Test Score (RAVLT)
timeFrame: Baseline
measure: Rey Auditory Verbal Learning Test Score (RAVLT)
timeFrame: Month 3
measure: Postural Control - Anterior-Posterior Postural Sway Score
timeFrame: Baseline and month 3
measure: Postural Control - Medial-Lateral Postural Sway Score
timeFrame: Baseline and month 3
measure: Postural Control - Maximum Path Velocity Score
timeFrame: Baseline and month 3
measure: Postural Control - Center of Pressure Area Score
timeFrame: Baseline and month 3
measure: Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits
timeFrame: Baseline
measure: Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits
timeFrame: Month 3
measure: Vestibular/Ocular Motor Screening (VOMS) - Convergence
timeFrame: Month 3
measure: Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades
timeFrame: Baseline
measure: Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades
timeFrame: Month 3
measure: Vestibular/Ocular Motor Screening (VOMS) - Convergence
timeFrame: Baseline
measure: Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity
timeFrame: Baseline
measure: Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades
timeFrame: Baseline
measure: Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades
timeFrame: Month 3
measure: Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex
timeFrame: Baseline
measure: Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity
timeFrame: Month 3
measure: Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence
timeFrame: Baseline
measure: Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence
timeFrame: Month 3
measure: Conners' Continuous Performance Test (CPT) - Reaction Speed
timeFrame: Baseline
measure: Conners' Continuous Performance Test (CPT)) - Omissions
timeFrame: Baseline
measure: Conners' Continuous Performance Test (CPT) - Omissions
timeFrame: Month 3
measure: Conners' Continuous Performance Test (CPT) - Commissions
timeFrame: Baseline
measure: Conners' Continuous Performance Test (CPT) - Commissions
timeFrame: Month 3
measure: Conners' Continuous Performance Test (CPT) - Perseverations
timeFrame: Baseline
measure: Conners' Continuous Performance Test (CPT) - Perseverations
timeFrame: Month 3
measure: Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score
timeFrame: Month 3
measure: (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score
timeFrame: Month 3
measure: (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score
timeFrame: Month 3
measure: NIH Toolbox Pattern Comparison Test Score
timeFrame: Baseline
measure: NIH Toolbox Pattern Comparison Test Score
timeFrame: Month 3
measure: (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score
timeFrame: Month 3
measure: (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score
timeFrame: Month 3
measure: Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex
timeFrame: Month 3
measure: Conners' Continuous Performance Test (CPT) - Reaction Speed
timeFrame: Month 3
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Jill Urban, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: