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

Community-Engaged Sport Safety - Aim 1 and Aim 3

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04908930
Enrollment
106
Registered
2021-06-01
Start date
2021-07-08
Completion date
2023-11-29
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Injury, Sport Injury

Keywords

Sport Safety, Youth Football, Head Impact Exposure

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.

Interventions

BEHAVIORALOn-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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Number of Head ImpactsMonth 3Head 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 MinuteMonth 3Head 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 PracticeMonth 3Head 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 PracticeMonth 3Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
Median Linear Acceleration (g)Month 3Head 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 AccelerationMonth 3Head 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 VelocityMonth 3Head 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 Linear Acceleration (g)Month 3Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration.
95th Percentile Rotational AccelerationMonth 3Head 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 VelocityMonth 3Head 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

MeasureTime frameDescription
NIH Toolbox List Sorting Working Memory Test ScoreBaselineParticipants 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 Vocabulary Test ScoreBaselineParticipants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better
NIH Toolbox Picture Sequence Memory Test ScoreBaseline and month 3Participants 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)BaselineThe 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
Postural Control - Anterior-Posterior Postural Sway ScoreBaseline and month 3Participants 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 ScoreBaseline and month 3Participants 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 ScoreBaseline and month 3Participants 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 ScoreBaseline and month 3Participants 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 PursuitsBaselineThe 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) - ConvergenceMonth 3The 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 SaccadesBaselineThe 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 SensitivityBaselineThe 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 SaccadesBaselineThe 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 ReflexBaselineThe 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 ConvergenceBaselineThe 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 SpeedBaselineParticipants 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)) - OmissionsBaselineParticipants 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
Feasibility of Intervention Measure (FIM)Month 3Perceived 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
Conners' Continuous Performance Test (CPT) - CommissionsBaselineParticipants 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) - PerseverationsBaselineParticipants 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 ScoreMonth 3ImPACT 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 ScoreBaselineThe 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 ScoreMonth 3ImPACT 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 ScoreMonth 3ImPACT 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
Conners' Continuous Performance Test (CPT) - OmissionsMonth 3Participants 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
Acceptability of Intervention Measure (AIM)Month 3total range 0 - 5 higher values denote better acceptability of the intervention (higher scores are better)
Percentage of Practices the Intervention Was Implemented as PrescribedMonth 3The 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 InterventionMonth 3Adaptations 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 TestingBaselineImPACT 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 TestingBaselineImPACT 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 ScoreBaselineImPACT 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 ScoreBaselineImPACT 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 ScoreBaselineImPACT 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
Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test ScoreBaselineParticipants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better

Countries

United States

Participant flow

Participants by arm

ArmCount
Unexposed Practice Group- Aim 1
Data from an unexposed sample (football players practicing as they would otherwise).
36
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
34
Unexposed Practice Group- Aim 1 Stakeholders
Coach stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football
6
On-field Activity Group - Aim 3 Stakeholders
Coach stakeholders pilot tested the intervention
12
Unexposed Practice Group - Other Aim Stakeholders
Parent and organizational leader stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football
18
Total106

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall Studyhardware in mouth11000
Overall StudyLost to Follow-up11000
Overall Studyparent not liking program01000
Overall Studyquit team24000
Overall StudyWithdrawal by Subject12000
Overall Studywrong team10000

Baseline characteristics

CharacteristicUnexposed Practice Group- Aim 1TotalUnexposed Practice Group - Other Aim StakeholdersOn-field Activity Group - Aim 3 StakeholdersUnexposed Practice Group- Aim 1 StakeholdersOn-field Activity Group - Aim 3
Age, Continuous12.4 years
STANDARD_DEVIATION 0.55
12.4 years
STANDARD_DEVIATION 0.7
39.0 years
STANDARD_DEVIATION 6.7
34.5 years
STANDARD_DEVIATION 6.7
33.5 years
STANDARD_DEVIATION 5.2
12.5 years
STANDARD_DEVIATION 0.82
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants12 Participants1 Participants0 Participants0 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants87 Participants16 Participants12 Participants5 Participants23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants7 Participants1 Participants0 Participants1 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
25 Participants59 Participants10 Participants9 Participants4 Participants11 Participants
Race (NIH/OMB)
More than one race
3 Participants9 Participants1 Participants1 Participants0 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants9 Participants1 Participants1 Participants1 Participants4 Participants
Race (NIH/OMB)
White
6 Participants29 Participants6 Participants1 Participants1 Participants15 Participants
Sex/Gender, Customized
Female
0 Participants9 Participants9 Participants0 Participants0 Participants0 Participants
Sex/Gender, Customized
Male
36 Participants96 Participants8 Participants12 Participants6 Participants34 Participants
Sex/Gender, Customized
Unknown
0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 340 / 60 / 120 / 18
other
Total, other adverse events
0 / 360 / 340 / 60 / 120 / 18
serious
Total, serious adverse events
0 / 360 / 340 / 60 / 120 / 18

Outcome results

Primary

95th Percentile Linear Acceleration (g)

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.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 195th Percentile Linear Acceleration (g)25.8 gStandard Deviation 6.83
On-field Activity Group - Aim 395th Percentile Linear Acceleration (g)31.86 gStandard Deviation 10.46
Primary

95th Percentile Number of Impacts Per Athlete Per Practice

Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 195th Percentile Number of Impacts Per Athlete Per Practice15.12 Impacts/Athlete/ PracticeStandard Deviation 10.73
On-field Activity Group - Aim 395th Percentile Number of Impacts Per Athlete Per Practice10.12 Impacts/Athlete/ PracticeStandard Deviation 5.95
Primary

95th Percentile Rotational Acceleration

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.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 195th Percentile Rotational Acceleration2013.18 rad/s^2Standard Deviation 1014.19
On-field Activity Group - Aim 395th Percentile Rotational Acceleration2928.97 rad/s^2Standard Deviation 1340.6
Primary

95th Percentile Rotational Velocity

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.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 195th Percentile Rotational Velocity17.19 rad/sStandard Deviation 2.89
On-field Activity Group - Aim 395th Percentile Rotational Velocity21.21 rad/sStandard Deviation 5.24
Primary

Mean Number of Impacts Per Athlete Per Practice

Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Mean Number of Impacts Per Athlete Per Practice4.75 Impacts per athlete per practiceStandard Deviation 3.35
On-field Activity Group - Aim 3Mean Number of Impacts Per Athlete Per Practice2.74 Impacts per athlete per practiceStandard Deviation 2.03
Primary

Median Linear Acceleration (g)

Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Median Linear Acceleration (g)9.63 gStandard Deviation 2.05
On-field Activity Group - Aim 3Median Linear Acceleration (g)12.7 gStandard Deviation 3.74
Primary

Median Rotational Acceleration

Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Median Rotational Acceleration722.03 rad/s^2Standard Deviation 295.31
On-field Activity Group - Aim 3Median Rotational Acceleration1035.21 rad/s^2Standard Deviation 451.41
Primary

Median Rotational Velocity

Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Median Rotational Velocity9.03 rad/sStandard Deviation 2.25
On-field Activity Group - Aim 3Median Rotational Velocity10.28 rad/sStandard Deviation 3.25
Primary

Number of Head Impacts

Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Number of Head Impacts100.24 total number of practice impactsStandard Deviation 81.06
On-field Activity Group - Aim 3Number of Head Impacts50.27 total number of practice impactsStandard Deviation 39.57
Primary

Number of Impacts Per Player Per Minute

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

Time frame: Month 3

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece, 1 quit team before contact, and 1 did not attend practice sessions.~On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Number of Impacts Per Player Per Minute0.047 impacts per player per minuteStandard Deviation 0.03
On-field Activity Group - Aim 3Number of Impacts Per Player Per Minute0.026 impacts per player per minuteStandard Deviation 0.02
Secondary

Acceptability of Intervention Measure (AIM)

total range 0 - 5 higher values denote better acceptability of the intervention (higher scores are better)

Time frame: Month 3

Population: No data collected for this outcome for the Unexposed Practice Group Stakeholders.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Acceptability of Intervention Measure (AIM)5 score on a scaleStandard Deviation 0
On-field Activity Group - Aim 3Acceptability of Intervention Measure (AIM)4.54 score on a scaleStandard Deviation 0.5
Secondary

Conners' Continuous Performance Test (CPT) - Commissions

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

Time frame: Baseline

Population: Missing from each group-- Unexposed practice group: 1 incompatible with mouthpiece~On-field activity group: 1 incompatible with mouthpiece, 1 received invalid CPT results, 1 didn't attend baseline testing, and 3 joined the study after the start of contact

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Conners' Continuous Performance Test (CPT) - Commissions52.57 T scoreStandard Deviation 7.93
On-field Activity Group - Aim 3Conners' Continuous Performance Test (CPT) - Commissions50.14 T scoreStandard Deviation 8.15
Secondary

Conners' Continuous Performance Test (CPT) - Commissions

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

Time frame: Month 3

Population: Missing participants--Unexposed group: 1 incompatible with mouthpiece, 1 had injury, 3 quit team, 1 did not like mouthpiece, 5 didn't return for post-season neurocognitive testing. On-field activity group: 1 incompatible with mouthpiece,1 athlete's parent withdrew consent, 4 quit the team, 2 didn't like mouthpiece, 1 received invalid CPT results, 1 did not attend baseline neurocognitive testing, 3 joined study after start of contact in season,1 athlete didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Conners' Continuous Performance Test (CPT) - Commissions50.56 T scoreStandard Deviation 8.69
On-field Activity Group - Aim 3Conners' Continuous Performance Test (CPT) - Commissions47.20 T scoreStandard Deviation 8.82
Secondary

Conners' Continuous Performance Test (CPT) - Omissions

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

Time frame: Month 3

Population: Missing participants--Unexposed group: 1 incompatible with mouthpiece, 1 had injury, 3 quit team, 1 did not like mouthpiece, 5 didn't return for post-season neurocognitive testing. On-field activity group: 1 incompatible with mouthpiece,1 athlete's parent withdrew consent, 4 quit the team, 2 didn't like mouthpiece, 1 received invalid CPT results, 1 did not attend baseline neurocognitive testing, 3 joined study after start of contact in season,1 athlete didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Conners' Continuous Performance Test (CPT) - Omissions61.68 T-scoreStandard Deviation 16.23
On-field Activity Group - Aim 3Conners' Continuous Performance Test (CPT) - Omissions52.30 T-scoreStandard Deviation 12.04
Secondary

Conners' Continuous Performance Test (CPT)) - Omissions

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

Time frame: Baseline

Population: Missing from each group-- Unexposed practice group: 1 incompatible with mouthpiece~On-field activity group: 1 incompatible with mouthpiece, 1 received invalid CPT results, 1 didn't attend baseline testing, and 3 joined the study after the start of contact

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Conners' Continuous Performance Test (CPT)) - Omissions64.46 T scoreStandard Deviation 16.7
On-field Activity Group - Aim 3Conners' Continuous Performance Test (CPT)) - Omissions55.07 T scoreStandard Deviation 14.99
Secondary

Conners' Continuous Performance Test (CPT) - Perseverations

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

Time frame: Baseline

Population: Missing participants-- Unexposed practice group: 1 incompatible with mouthpiece~On-field activity group: 1 incompatible with mouthpiece, 1 received invalid CPT results, 1 didn't attend baseline testing, and 3 joined the study after the start of contact

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Conners' Continuous Performance Test (CPT) - Perseverations67.74 T scoreStandard Deviation 18.71
On-field Activity Group - Aim 3Conners' Continuous Performance Test (CPT) - Perseverations58.00 T scoreStandard Deviation 14.82
Secondary

Conners' Continuous Performance Test (CPT) - Perseverations

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

Time frame: Month 3

Population: Missing participants--Unexposed group: 1 incompatible with mouthpiece, 1 had injury, 3 quit team, 1 did not like mouthpiece, 5 didn't return for post-season neurocognitive testing. On-field activity group: 1 incompatible with mouthpiece,1 athlete's parent withdrew consent, 4 quit the team, 2 didn't like mouthpiece, 1 received invalid CPT results, 1 did not attend baseline neurocognitive testing, 3 joined study after start of contact in season,1 athlete didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Conners' Continuous Performance Test (CPT) - Perseverations68.48 T scoreStandard Deviation 18.98
On-field Activity Group - Aim 3Conners' Continuous Performance Test (CPT) - Perseverations54.75 T scoreStandard Deviation 16.46
Secondary

Conners' Continuous Performance Test (CPT) - Reaction Speed

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).

Time frame: Month 3

Population: Missing participants--Unexposed group: 1 incompatible with mouthpiece, 1 had injury, 3 quit team, 1 did not like mouthpiece, 5 didn't return for post-season neurocognitive testing. On-field activity group: 1 incompatible with mouthpiece,1 athlete's parent withdrew consent, 4 quit the team, 2 didn't like mouthpiece, 1 received invalid CPT results, 1 did not attend baseline neurocognitive testing, 3 joined study after start of contact in season,1 athlete didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Conners' Continuous Performance Test (CPT) - Reaction Speed51.48 T scoreStandard Deviation 11.33
On-field Activity Group - Aim 3Conners' Continuous Performance Test (CPT) - Reaction Speed45.60 T scoreStandard Deviation 4.42
Secondary

Conners' Continuous Performance Test (CPT) - Reaction Speed

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)

Time frame: Baseline

Population: Missing from each group-- Unexposed practice group: 1 incompatible with mouthpiece~On-field activity group: 1 incompatible with mouthpiece, 1 received invalid CPT results, 1 didn't attend baseline testing, and 3 joined the study after the start of contact

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Conners' Continuous Performance Test (CPT) - Reaction Speed55.34 T-scoreStandard Deviation 11.77
On-field Activity Group - Aim 3Conners' Continuous Performance Test (CPT) - Reaction Speed47.00 T-scoreStandard Deviation 9.5
Secondary

Feasibility of Intervention Measure (FIM)

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

Time frame: Month 3

Population: No data collected for this outcome for the Unexposed Practice Group Stakeholders.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Feasibility of Intervention Measure (FIM)4.75 score on a scaleStandard Deviation 0.18
On-field Activity Group - Aim 3Feasibility of Intervention Measure (FIM)4.41 score on a scaleStandard Deviation 0.54
Secondary

Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score

Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score93.2 score on a scaleStandard Deviation 20.98
On-field Activity Group - Aim 3Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score91.24 score on a scaleStandard Deviation 16.77
Secondary

Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score

Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score100.80 score on a scaleStandard Deviation 18.67
On-field Activity Group - Aim 3Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score98.19 score on a scaleStandard Deviation 22.26
Secondary

(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score11.80 score on a scaleStandard Deviation 9.65
On-field Activity Group - Aim 3(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score12.1 score on a scaleStandard Deviation 13.13
Secondary

(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score12.17 score on a scaleStandard Deviation 11.44
On-field Activity Group - Aim 3(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score11.17 score on a scaleStandard Deviation 7.18
Secondary

(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece)~On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score0.76 millisecondsStandard Deviation 0.11
On-field Activity Group - Aim 3(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score0.72 millisecondsStandard Deviation 0.1
Secondary

(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score0.71 millisecondsStandard Deviation 0.12
On-field Activity Group - Aim 3(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score0.70 millisecondsStandard Deviation 0.09
Secondary

(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score84.96 score on a scaleStandard Deviation 10.98
On-field Activity Group - Aim 3(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score81.62 score on a scaleStandard Deviation 15.04
Secondary

(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score73.76 score on a scaleStandard Deviation 10.28
On-field Activity Group - Aim 3(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score68.29 score on a scaleStandard Deviation 16.35
Secondary

(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score27.61 score on a scaleStandard Deviation 7.82
On-field Activity Group - Aim 3(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score27.87 score on a scaleStandard Deviation 6.22
Secondary

NIH Toolbox List Sorting Working Memory Test Score

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1NIH Toolbox List Sorting Working Memory Test Score128.28 score on a scaleStandard Deviation 14.58
On-field Activity Group - Aim 3NIH Toolbox List Sorting Working Memory Test Score104.95 score on a scaleStandard Deviation 17.45
Secondary

NIH Toolbox List Sorting Working Memory Test Score

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1NIH Toolbox List Sorting Working Memory Test Score105.77 score on a scaleStandard Deviation 14.82
On-field Activity Group - Aim 3NIH Toolbox List Sorting Working Memory Test Score103.76 score on a scaleStandard Deviation 15.99
Secondary

NIH Toolbox Pattern Comparison Test Score

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1NIH Toolbox Pattern Comparison Test Score91.03 number items correctStandard Deviation 26.49
On-field Activity Group - Aim 3NIH Toolbox Pattern Comparison Test Score102.10 number items correctStandard Deviation 26.3
Secondary

NIH Toolbox Pattern Comparison Test Score

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1NIH Toolbox Pattern Comparison Test Score106.12 number items correctStandard Deviation 19.78
On-field Activity Group - Aim 3NIH Toolbox Pattern Comparison Test Score113.86 number items correctStandard Deviation 27.89
Secondary

NIH Toolbox Picture Sequence Memory Test Score

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

Time frame: Baseline and month 3

Population: Data not collected from any athletes for this outcome because this task was inadvertently not included in the testing protocol.

Secondary

NIH Toolbox Picture Vocabulary Test Score

Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1NIH Toolbox Picture Vocabulary Test Score91.89 score on a scaleStandard Deviation 16.06
On-field Activity Group - Aim 3NIH Toolbox Picture Vocabulary Test Score92.28 score on a scaleStandard Deviation 11.68
Secondary

NIH Toolbox Picture Vocabulary Test Score

Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1NIH Toolbox Picture Vocabulary Test Score92.52 score on a scaleStandard Deviation 14.95
On-field Activity Group - Aim 3NIH Toolbox Picture Vocabulary Test Score91.29 score on a scaleStandard Deviation 11.18
Secondary

Number Changes to the Intervention

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.

Time frame: Month 3

Population: Unexposed Practice Group- Aim 1 was not assessed for this measure because there is no intervention in that group. Therefore, unexposed practice group number analyzed value is zero.~Missing participants--On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (NUMBER)
On-field Activity Group - Aim 3Number Changes to the Intervention0 number of adaptations
Secondary

Percentage of Practices the Intervention Was Implemented as Prescribed

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.

Time frame: Month 3

Population: Unexposed Practice Group- Aim 1 was not assessed for this measure because there is no intervention in that group.~Therefore, unexposed practice group number analyzed value is zero. Missing participants--On-Field activity group: 1 incompatible with mouthpiece, 2 quit team before contact, 2 didn't like mouthpiece fit

ArmMeasureValue (NUMBER)
On-field Activity Group - Aim 3Percentage of Practices the Intervention Was Implemented as Prescribed41.7 percentage
Secondary

Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score30.79 score on a scaleStandard Deviation 7.48
On-field Activity Group - Aim 3Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score30.30 score on a scaleStandard Deviation 8.7
Secondary

Postural Control - Anterior-Posterior Postural Sway Score

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

Time frame: Baseline and month 3

Secondary

Postural Control - Center of Pressure Area Score

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

Time frame: Baseline and month 3

Secondary

Postural Control - Maximum Path Velocity Score

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

Time frame: Baseline and month 3

Secondary

Postural Control - Medial-Lateral Postural Sway Score

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

Time frame: Baseline and month 3

Secondary

Rey Auditory Verbal Learning Test Score (RAVLT)

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Rey Auditory Verbal Learning Test Score (RAVLT)29.76 score on a scaleStandard Deviation 5.58
On-field Activity Group - Aim 3Rey Auditory Verbal Learning Test Score (RAVLT)25.71 score on a scaleStandard Deviation 7.44
Secondary

Rey Auditory Verbal Learning Test Score (RAVLT)

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Rey Auditory Verbal Learning Test Score (RAVLT)22.06 score on a scaleStandard Deviation 6.29
On-field Activity Group - Aim 3Rey Auditory Verbal Learning Test Score (RAVLT)23.28 score on a scaleStandard Deviation 6.47
Secondary

Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing74.57 score on a scaleStandard Deviation 14.2
On-field Activity Group - Aim 3Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing79.10 score on a scaleStandard Deviation 11.18
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Convergence

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.

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Convergence0.35 score on a scaleStandard Deviation 0.85
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Convergence0.09 score on a scaleStandard Deviation 0.31
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Convergence

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.

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Convergence0.13 score on a scaleStandard Deviation 0.39
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Convergence0.10 score on a scaleStandard Deviation 0.31
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades

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.

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades0.16 score on a scaleStandard Deviation 0.48
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades0.10 score on a scaleStandard Deviation 0.3
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades

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.

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades0.30 score on a scaleStandard Deviation 0.78
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades0.12 score on a scaleStandard Deviation 0.36
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex

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.

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex0.29 score on a scaleStandard Deviation 0.8
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex0.13 score on a scaleStandard Deviation 0.36
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex

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.

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex0.15 score on a scaleStandard Deviation 0.46
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex0.10 score on a scaleStandard Deviation 0.31
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence

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

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence6.00 centimetersStandard Deviation 4.92
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence3.38 centimetersStandard Deviation 4.96
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence6.48 centimetersStandard Deviation 5.71
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence2.97 centimetersStandard Deviation 2.93
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits

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.

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits0.15 score on a scaleStandard Deviation 0.49
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits0.06 score on a scaleStandard Deviation 0.27
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits

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.

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits0.25 score on a scaleStandard Deviation 0.76
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits0.11 score on a scaleStandard Deviation 0.39
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades

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.

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades0.34 score on a scaleStandard Deviation 0.84
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades0.12 score on a scaleStandard Deviation 0.36
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades

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.

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades0.15 score on a scaleStandard Deviation 0.49
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades0.10 score on a scaleStandard Deviation 0.31
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity

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.

Time frame: Month 3

Population: Missing from each group-- Unexposed practice group: 1 was incompatible with mouthpiece, 1 had season-ending injury, 3 quit team, 1 did not like mouthpiece, and 5 did not return for testing.~On-field activity group: 1 incompatible with mouthpiece, 1 athlete's parent withdrew consent, 4 quit the team, 2 did not like mouthpiece, 1 did not attend baseline testing, 3 joined study after start of contact during season, 1 didn't return for post-season testing.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity0.17 score on a scaleStandard Deviation 0.52
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity0.10 score on a scaleStandard Deviation 0.33
Secondary

Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity

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.

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity0.37 score on a scaleStandard Deviation 0.89
On-field Activity Group - Aim 3Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity0.10 score on a scaleStandard Deviation 0.39
Secondary

Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing

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

Time frame: Baseline

Population: Missing participants-- Unexposed Group: 1 athlete did not complete data collection due to hardware in mouth (incompatible with mouthpiece) On-field Activity Group: 1 athlete did not have complete data collection due to hardware in mouth (incompatible with mouthpiece); 1 athlete did not attend baseline testing, and 3 athletes joined the study after the start of contact.

ArmMeasureValue (MEAN)Dispersion
Unexposed Practice Group- Aim 1Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing63.77 score on a scaleStandard Deviation 14.87
On-field Activity Group - Aim 3Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing69.79 score on a scaleStandard Deviation 13.24

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026