Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3

Not Applicable

Completed

Conditions: Head Injury
Sport Injury

Interventions: Behavioral: On-field activity group - Aim 3

Registration Number: NCT04908930

Lead Sponsor: Wake Forest University Health Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 106

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
On-field activity group - Aim 3	On-field activity group - Aim 3	Athletes of two new teams at the middle school level to pilot the practice structure intervention and continuously monitor on-field activity with head impact sensors to evaluate the feasibility, acceptability, and sustainability of the practice structure

Primary Outcome Measures

Name	Time	Method
Number of Head Impacts	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
Number of Impacts Per Player Per Minute	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. Number of impacts per player per minute
Mean Number of Impacts Per Athlete Per Practice	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
95th Percentile Number of Impacts Per Athlete Per Practice	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
95th Percentile Linear Acceleration (g)	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration.
Median Linear Acceleration (g)	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.
Median Rotational Acceleration	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.
Median Rotational Velocity	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.
95th Percentile Rotational Acceleration	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration.
95th Percentile Rotational Velocity	Month 3	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Intervention Measure (FIM)	Month 3	Perceived feasibility - higher values denote better feasibility - total range 0 - 5; 1, completely disagree; 5, completely agree - higher scores denote more possibility and agreeability to Intervention
Acceptability of Intervention Measure (AIM)	Month 3	total range 0 - 5 higher values denote better acceptability of the intervention (higher scores are better)
Percentage of Practices the Intervention Was Implemented as Prescribed	Month 3	The intervention was prescribed to the North Carolina High School Athletic Association guidelines for contact in football practices, which limits teams to 15 minutes of live action contact per week. The percentage of practices the intervention was implemented as prescribed was monitored. An implementation score of 2 was given for adequate implementation (\<15 minutes), 1 was given for partial implementation (\<30 minutes), and 0 was given if live action contact exceeded 30 minutes for each practice. The percentage was calculated as the summed score for the season, divided by the maximum possible score across intervention teams.
Number Changes to the Intervention	Month 3	Adaptations to the intervention will be tracked as the number of changes to the intervention during the football season. Coach initiated adaptions will be tracked via visual observation. Adaptations advised by the stakeholder team will be tracked via meeting notes.
Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing	Baseline	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better
Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing	Baseline	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score	Baseline	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score	Month 3	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-1; lower scores are better
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score	Month 3	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores. Impulse control is a measure of errors on testing and is useful in determining test validity. This score indicates the sum of errors committed during different phases of the test - 0-40; lower scores are better
NIH Toolbox List Sorting Working Memory Test Score	Month 3	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - List Sorting Working Memory; the score range is 50-150 - higher scores are better
NIH Toolbox Picture Sequence Memory Test Score	Baseline and month 3	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Sequence Memory - 70-120; higher scores are better
Rey Auditory Verbal Learning Test Score (RAVLT)	Month 3	The RAVLT assesses verbal learning ability - A series of 15 words is presented to the participant 3 times via audio recording for standardization, and answers are recorded - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-45; higher scores are better
Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score	Month 3	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better
NIH Toolbox Picture Vocabulary Test Score	Month 3	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better
Postural Control - Anterior-Posterior Postural Sway Score	Baseline and month 3	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better
Postural Control - Medial-Lateral Postural Sway Score	Baseline and month 3	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better
Postural Control - Maximum Path Velocity Score	Baseline and month 3	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-10; lower scores are better
Postural Control - Center of Pressure Area Score	Baseline and month 3	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-20; lower scores are better
Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits	Month 3	The participant will be asked to focus on a small target that will be moved horizontally and vertically. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.
Vestibular/Ocular Motor Screening (VOMS) - Convergence	Baseline	The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades	Month 3	The participant will be asked to focus on two small targets that are horizontally aligned, moving their eyes quickly from one target to the other. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.
Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity	Month 3	The participant will be asked to focus on a small target that they are holding still while rotating their torso from side to side. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.
Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades	Month 3	The participant will be asked to focus on two small targets that are vertically aligned, moving their eyes quickly from one target to the other. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex	Month 3	The participant will be asked to focus on one small target while rotating their head from side to side. The participant will report any symptoms (i.e., headache, dizziness, nausea, fogginess) after the task is complete. Symptoms reported range on a scale from 0-10; lower scores are better.
Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence	Month 3	The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 15; lower scores are better
Conners' Continuous Performance Test (CPT) - Reaction Speed	Month 3	Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Reaction Speed; Raw reaction speed is the mean response speed for all non-perseverative responses made during the entire Test. Raw reaction speed is converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is atypically slow and \<40 is atypically fast. Reaction speed is bi-directional with higher scores indicating slower reaction times (i.e., inattentiveness), and lower scores indicating faster reaction times (i.e., impulsivity).
Conners' Continuous Performance Test (CPT)) - Omissions	Baseline	Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Omissions; Raw omissions scores are based on the number of missed targets during the test. Raw omissions scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very elevated and indicates poor performance. Higher scores indicate poorer performance
Conners' Continuous Performance Test (CPT) - Omissions	Month 3	Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Omissions; Raw omissions scores are based on the number of missed targets during the test. Raw omissions scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very elevated and indicates poor performance. Higher scores indicate poorer performance
Conners' Continuous Performance Test (CPT) - Commissions	Month 3	Participants will complete a 14-minute computerbased assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Commission; Raw commissions are incorrect responses to non-targets. Raw commissions scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very conservative and indicates much emphasis on accuracy over speed and ≤30 is very liberal and indicates much emphasis on speed over accuracy. Scores indicate the nature of participants' response style rather than performance
Conners' Continuous Performance Test (CPT) - Perseverations	Month 3	Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Perseverations; Raw perseverations are responses that are made in less than 100 milliseconds following a stimulus. Raw perseverations scores are converted to standardized T-scores 0-90; 50 indicates the population mean with a standard deviation of 10. 70+ is very elevated and indicates poor performance. Higher scores indicate poorer performance
Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score	Month 3	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better
NIH Toolbox Pattern Comparison Test Score	Month 3	The Pattern Comparison Test is a measure of speed of processing, which typically improves steadily (time to complete task decreases) throughout childhood and adolescence, then begins to decline in adulthood, becoming much slower in older adults. As such, it is considered a "fluid ability" measure. Score range: 0-130
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score	Month 3	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score	Month 3	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better