Head Injury, Sport Injury
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| NIH Toolbox List Sorting Working Memory Test Score | Baseline | 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 Vocabulary Test Score | Baseline | Participants 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 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) | Baseline | 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 |
| 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 | Baseline | 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 | 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. 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 | Baseline | 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 | Baseline | 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 | Baseline | 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 | Baseline | 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 | 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 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 | 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 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 |
| 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 |
| Conners' Continuous Performance Test (CPT) - Commissions | Baseline | 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 | 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 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 | Baseline | 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 |
| 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 |
| 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 | 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 - 0-1; lower scores are better |
| (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control 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. 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 Score | Baseline | Participants 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
| Arm | Count |
|---|---|
| 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 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | hardware in mouth | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 |
| Overall Study | parent not liking program | 0 | 1 | 0 | 0 | 0 |
| Overall Study | quit team | 2 | 4 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 | 0 | 0 |
| Overall Study | wrong team | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Unexposed Practice Group- Aim 1 | Total | Unexposed Practice Group - Other Aim Stakeholders | On-field Activity Group - Aim 3 Stakeholders | Unexposed Practice Group- Aim 1 Stakeholders | On-field Activity Group - Aim 3 |
|---|---|---|---|---|---|---|
| Age, Continuous | 12.4 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 Participants | 12 Participants | 1 Participants | 0 Participants | 0 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 87 Participants | 16 Participants | 12 Participants | 5 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 7 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 59 Participants | 10 Participants | 9 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 9 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 9 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 6 Participants | 29 Participants | 6 Participants | 1 Participants | 1 Participants | 15 Participants |
| Sex/Gender, Customized Female | 0 Participants | 9 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Male | 36 Participants | 96 Participants | 8 Participants | 12 Participants | 6 Participants | 34 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 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 / 36 | 0 / 34 | 0 / 6 | 0 / 12 | 0 / 18 |
| other Total, other adverse events | 0 / 36 | 0 / 34 | 0 / 6 | 0 / 12 | 0 / 18 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 | 0 / 6 | 0 / 12 | 0 / 18 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | 95th Percentile Linear Acceleration (g) | 25.8 g | Standard Deviation 6.83 |
| On-field Activity Group - Aim 3 | 95th Percentile Linear Acceleration (g) | 31.86 g | Standard Deviation 10.46 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | 95th Percentile Number of Impacts Per Athlete Per Practice | 15.12 Impacts/Athlete/ Practice | Standard Deviation 10.73 |
| On-field Activity Group - Aim 3 | 95th Percentile Number of Impacts Per Athlete Per Practice | 10.12 Impacts/Athlete/ Practice | Standard Deviation 5.95 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | 95th Percentile Rotational Acceleration | 2013.18 rad/s^2 | Standard Deviation 1014.19 |
| On-field Activity Group - Aim 3 | 95th Percentile Rotational Acceleration | 2928.97 rad/s^2 | Standard Deviation 1340.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | 95th Percentile Rotational Velocity | 17.19 rad/s | Standard Deviation 2.89 |
| On-field Activity Group - Aim 3 | 95th Percentile Rotational Velocity | 21.21 rad/s | Standard Deviation 5.24 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Mean Number of Impacts Per Athlete Per Practice | 4.75 Impacts per athlete per practice | Standard Deviation 3.35 |
| On-field Activity Group - Aim 3 | Mean Number of Impacts Per Athlete Per Practice | 2.74 Impacts per athlete per practice | Standard Deviation 2.03 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Median Linear Acceleration (g) | 9.63 g | Standard Deviation 2.05 |
| On-field Activity Group - Aim 3 | Median Linear Acceleration (g) | 12.7 g | Standard Deviation 3.74 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Median Rotational Acceleration | 722.03 rad/s^2 | Standard Deviation 295.31 |
| On-field Activity Group - Aim 3 | Median Rotational Acceleration | 1035.21 rad/s^2 | Standard Deviation 451.41 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Median Rotational Velocity | 9.03 rad/s | Standard Deviation 2.25 |
| On-field Activity Group - Aim 3 | Median Rotational Velocity | 10.28 rad/s | Standard Deviation 3.25 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Number of Head Impacts | 100.24 total number of practice impacts | Standard Deviation 81.06 |
| On-field Activity Group - Aim 3 | Number of Head Impacts | 50.27 total number of practice impacts | Standard Deviation 39.57 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Number of Impacts Per Player Per Minute | 0.047 impacts per player per minute | Standard Deviation 0.03 |
| On-field Activity Group - Aim 3 | Number of Impacts Per Player Per Minute | 0.026 impacts per player per minute | Standard Deviation 0.02 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Acceptability of Intervention Measure (AIM) | 5 score on a scale | Standard Deviation 0 |
| On-field Activity Group - Aim 3 | Acceptability of Intervention Measure (AIM) | 4.54 score on a scale | Standard Deviation 0.5 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Conners' Continuous Performance Test (CPT) - Commissions | 52.57 T score | Standard Deviation 7.93 |
| On-field Activity Group - Aim 3 | Conners' Continuous Performance Test (CPT) - Commissions | 50.14 T score | Standard Deviation 8.15 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Conners' Continuous Performance Test (CPT) - Commissions | 50.56 T score | Standard Deviation 8.69 |
| On-field Activity Group - Aim 3 | Conners' Continuous Performance Test (CPT) - Commissions | 47.20 T score | Standard Deviation 8.82 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Conners' Continuous Performance Test (CPT) - Omissions | 61.68 T-score | Standard Deviation 16.23 |
| On-field Activity Group - Aim 3 | Conners' Continuous Performance Test (CPT) - Omissions | 52.30 T-score | Standard Deviation 12.04 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Conners' Continuous Performance Test (CPT)) - Omissions | 64.46 T score | Standard Deviation 16.7 |
| On-field Activity Group - Aim 3 | Conners' Continuous Performance Test (CPT)) - Omissions | 55.07 T score | Standard Deviation 14.99 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Conners' Continuous Performance Test (CPT) - Perseverations | 67.74 T score | Standard Deviation 18.71 |
| On-field Activity Group - Aim 3 | Conners' Continuous Performance Test (CPT) - Perseverations | 58.00 T score | Standard Deviation 14.82 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Conners' Continuous Performance Test (CPT) - Perseverations | 68.48 T score | Standard Deviation 18.98 |
| On-field Activity Group - Aim 3 | Conners' Continuous Performance Test (CPT) - Perseverations | 54.75 T score | Standard Deviation 16.46 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Conners' Continuous Performance Test (CPT) - Reaction Speed | 51.48 T score | Standard Deviation 11.33 |
| On-field Activity Group - Aim 3 | Conners' Continuous Performance Test (CPT) - Reaction Speed | 45.60 T score | Standard Deviation 4.42 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Conners' Continuous Performance Test (CPT) - Reaction Speed | 55.34 T-score | Standard Deviation 11.77 |
| On-field Activity Group - Aim 3 | Conners' Continuous Performance Test (CPT) - Reaction Speed | 47.00 T-score | Standard Deviation 9.5 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Feasibility of Intervention Measure (FIM) | 4.75 score on a scale | Standard Deviation 0.18 |
| On-field Activity Group - Aim 3 | Feasibility of Intervention Measure (FIM) | 4.41 score on a scale | Standard Deviation 0.54 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score | 93.2 score on a scale | Standard Deviation 20.98 |
| On-field Activity Group - Aim 3 | Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score | 91.24 score on a scale | Standard Deviation 16.77 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score | 100.80 score on a scale | Standard Deviation 18.67 |
| On-field Activity Group - Aim 3 | Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score | 98.19 score on a scale | Standard Deviation 22.26 |
(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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score | 11.80 score on a scale | Standard Deviation 9.65 |
| On-field Activity Group - Aim 3 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score | 12.1 score on a scale | Standard Deviation 13.13 |
(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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score | 12.17 score on a scale | Standard Deviation 11.44 |
| On-field Activity Group - Aim 3 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score | 11.17 score on a scale | Standard Deviation 7.18 |
(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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score | 0.76 milliseconds | Standard Deviation 0.11 |
| On-field Activity Group - Aim 3 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score | 0.72 milliseconds | Standard Deviation 0.1 |
(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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score | 0.71 milliseconds | Standard Deviation 0.12 |
| On-field Activity Group - Aim 3 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score | 0.70 milliseconds | Standard Deviation 0.09 |
(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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score | 84.96 score on a scale | Standard Deviation 10.98 |
| On-field Activity Group - Aim 3 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score | 81.62 score on a scale | Standard Deviation 15.04 |
(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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score | 73.76 score on a scale | Standard Deviation 10.28 |
| On-field Activity Group - Aim 3 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score | 68.29 score on a scale | Standard Deviation 16.35 |
(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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score | 27.61 score on a scale | Standard Deviation 7.82 |
| On-field Activity Group - Aim 3 | (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score | 27.87 score on a scale | Standard Deviation 6.22 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | NIH Toolbox List Sorting Working Memory Test Score | 128.28 score on a scale | Standard Deviation 14.58 |
| On-field Activity Group - Aim 3 | NIH Toolbox List Sorting Working Memory Test Score | 104.95 score on a scale | Standard Deviation 17.45 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | NIH Toolbox List Sorting Working Memory Test Score | 105.77 score on a scale | Standard Deviation 14.82 |
| On-field Activity Group - Aim 3 | NIH Toolbox List Sorting Working Memory Test Score | 103.76 score on a scale | Standard Deviation 15.99 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | NIH Toolbox Pattern Comparison Test Score | 91.03 number items correct | Standard Deviation 26.49 |
| On-field Activity Group - Aim 3 | NIH Toolbox Pattern Comparison Test Score | 102.10 number items correct | Standard Deviation 26.3 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | NIH Toolbox Pattern Comparison Test Score | 106.12 number items correct | Standard Deviation 19.78 |
| On-field Activity Group - Aim 3 | NIH Toolbox Pattern Comparison Test Score | 113.86 number items correct | Standard Deviation 27.89 |
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | NIH Toolbox Picture Vocabulary Test Score | 91.89 score on a scale | Standard Deviation 16.06 |
| On-field Activity Group - Aim 3 | NIH Toolbox Picture Vocabulary Test Score | 92.28 score on a scale | Standard Deviation 11.68 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | NIH Toolbox Picture Vocabulary Test Score | 92.52 score on a scale | Standard Deviation 14.95 |
| On-field Activity Group - Aim 3 | NIH Toolbox Picture Vocabulary Test Score | 91.29 score on a scale | Standard Deviation 11.18 |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| On-field Activity Group - Aim 3 | Number Changes to the Intervention | 0 number of adaptations |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| On-field Activity Group - Aim 3 | Percentage of Practices the Intervention Was Implemented as Prescribed | 41.7 percentage |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score | 30.79 score on a scale | Standard Deviation 7.48 |
| On-field Activity Group - Aim 3 | Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score | 30.30 score on a scale | Standard Deviation 8.7 |
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
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
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
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Rey Auditory Verbal Learning Test Score (RAVLT) | 29.76 score on a scale | Standard Deviation 5.58 |
| On-field Activity Group - Aim 3 | Rey Auditory Verbal Learning Test Score (RAVLT) | 25.71 score on a scale | Standard Deviation 7.44 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Rey Auditory Verbal Learning Test Score (RAVLT) | 22.06 score on a scale | Standard Deviation 6.29 |
| On-field Activity Group - Aim 3 | Rey Auditory Verbal Learning Test Score (RAVLT) | 23.28 score on a scale | Standard Deviation 6.47 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing | 74.57 score on a scale | Standard Deviation 14.2 |
| On-field Activity Group - Aim 3 | Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing | 79.10 score on a scale | Standard Deviation 11.18 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Convergence | 0.35 score on a scale | Standard Deviation 0.85 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Convergence | 0.09 score on a scale | Standard Deviation 0.31 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Convergence | 0.13 score on a scale | Standard Deviation 0.39 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Convergence | 0.10 score on a scale | Standard Deviation 0.31 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades | 0.16 score on a scale | Standard Deviation 0.48 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades | 0.10 score on a scale | Standard Deviation 0.3 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades | 0.30 score on a scale | Standard Deviation 0.78 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades | 0.12 score on a scale | Standard Deviation 0.36 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex | 0.29 score on a scale | Standard Deviation 0.8 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex | 0.13 score on a scale | Standard Deviation 0.36 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex | 0.15 score on a scale | Standard Deviation 0.46 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex | 0.10 score on a scale | Standard Deviation 0.31 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence | 6.00 centimeters | Standard Deviation 4.92 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence | 3.38 centimeters | Standard Deviation 4.96 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence | 6.48 centimeters | Standard Deviation 5.71 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence | 2.97 centimeters | Standard Deviation 2.93 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits | 0.15 score on a scale | Standard Deviation 0.49 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits | 0.06 score on a scale | Standard Deviation 0.27 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits | 0.25 score on a scale | Standard Deviation 0.76 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits | 0.11 score on a scale | Standard Deviation 0.39 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades | 0.34 score on a scale | Standard Deviation 0.84 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades | 0.12 score on a scale | Standard Deviation 0.36 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades | 0.15 score on a scale | Standard Deviation 0.49 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades | 0.10 score on a scale | Standard Deviation 0.31 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity | 0.17 score on a scale | Standard Deviation 0.52 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity | 0.10 score on a scale | Standard Deviation 0.33 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity | 0.37 score on a scale | Standard Deviation 0.89 |
| On-field Activity Group - Aim 3 | Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity | 0.10 score on a scale | Standard Deviation 0.39 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unexposed Practice Group- Aim 1 | Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing | 63.77 score on a scale | Standard Deviation 14.87 |
| On-field Activity Group - Aim 3 | Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing | 69.79 score on a scale | Standard Deviation 13.24 |