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| ID | Type | Description | Link |
|---|---|---|---|
| K25HD101686 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unexposed practice group- Aim 1 | No Intervention | Data from an unexposed sample (football players practicing as they would otherwise). | |
| On-field activity group - Aim 3 | Experimental | 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 |
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| Unexposed practice group- Aim 1 Stakeholders | No Intervention | Stakeholders (parents, coaches, league officials) participated in guided discussions using an audit and feedback approach (sharing biomechanical data with the stakeholders) and semi-structured focus groups with the coaches and parents of the participating teams. Also, key informant interviews with league officials were used to assess the awareness and receptivity to creating a safer practice structure. | |
| On-field activity group - Aim 3 Stakeholders | Experimental | coaches pilot tested the COACH program |
|
| Unexposed Practice Group - Other Aim Stakeholders | No Intervention | Parent and organizational leader stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On-field activity group - Aim 3 | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3 |
| 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 | Month 3 |
| 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. | Month 3 |
| 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. | Month 3 |
| 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. | Month 3 |
| 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. | Month 3 |
| Median Rotational Velocity |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 3 |
| Acceptability of Intervention Measure (AIM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Urban, PhD, MPH | Wake Forest Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39351080 | Derived | Urban JE, Moore JB, Marks ME, Holcomb TD, Patterson R, McCoy A, Miles CM, Stitzel JD, Foley KL. Protocol for COACH, an evidence-based intervention for improved head impact safety in youth American football developed using a community-engaged approach. Contemp Clin Trials Commun. 2024 Sep 17;42:101371. doi: 10.1016/j.conctc.2024.101371. eCollection 2024 Dec. |
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Participant Data and Study Protocol
Beginning 9 months and ending 36 months following article publication
Individual participant data (IPD) collected in this study be shared using the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system. The National Institute of Health FITBIR database is a data sharing resource for the Traumatic Brain Injury imaging research field. Data sharing forms will be used to upload biomechanical data and associated metadata according to the The National Institute of Neurological Disorders and Stroke Department of Defense (NINDS/DoD) Biomechanical Devices in TBI Common Data Elements (CDE). All data summarized in publications will also be made available upon email request to the study Principal Investigator and upon completion of a data-sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unexposed Practice Group- Aim 1 | Data from an unexposed sample (football players practicing as they would otherwise). |
| FG001 | 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 |
| FG002 | Unexposed Practice Group- Aim 1 (Stakeholders) | Coach stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football |
| FG003 | On-field Activity Group - Aim 3 (Stakeholders) | Coach stakeholders pilot tested the intervention |
| FG004 | Unexposed Practice Group - Other Stakeholders | Parent and organizational leader stakeholders (unexposed to intervention) participated in discussions about safety and biomechanics in youth football. Did not participate in the biomechanical and neurocognitive assessments in other arms. No outcomes associated with this arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Unexposed Practice Group- Aim 1 | Data from an unexposed sample (football players practicing as they would otherwise). |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | total number of practice impacts | Month 3 |
|
13 weeks
Study team depended on Parents and Coaches to report AEs
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unexposed Practice Group- Aim 1 | Data from an unexposed sample (football players practicing as they would otherwise). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jillian Urban, PhD | Wake Forest University Health Sciences | 336.716.0947 | jurban@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2024 | Oct 4, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 21, 2023 | Jan 5, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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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.
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|
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.
| Month 3 |
| 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. | Month 3 |
| 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. | Month 3 |
| 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. | Month 3 |
total range 0 - 5 higher values denote better acceptability of the intervention (higher scores are better) |
| Month 3 |
| 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. | Month 3 |
| 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. | Month 3 |
| 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 | Baseline |
| 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 | Baseline |
| (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 | Baseline |
| (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 | Baseline |
| (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 | Baseline |
| 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 | Baseline |
| 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 | Month 3 |
| 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 | Baseline |
| 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 | Month 3 |
| 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 | Baseline |
| 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 | Baseline and month 3 |
| 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 | 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 | Baseline |
| 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 | Month 3 |
| 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 | 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 | 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 | 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 | Baseline and month 3 |
| 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. | Baseline |
| 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. | Month 3 |
| 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. | Month 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. | Baseline |
| 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. | Month 3 |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Month 3 |
| 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. | Baseline |
| 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. | Month 3 |
| 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 | Baseline |
| 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 | Month 3 |
| 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) | Baseline |
| 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 | Baseline |
| 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 | Month 3 |
| 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 | Baseline |
| 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 | Month 3 |
| 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 | Baseline |
| 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 | Month 3 |
| 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 | Month 3 |
| (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 | Month 3 |
| (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 | Month 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 | Baseline |
| 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 | Month 3 |
| (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 | Month 3 |
| (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 | Month 3 |
| 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. | Month 3 |
| 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). | Month 3 |
| hardware in mouth |
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| wrong team |
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| quit team |
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| Withdrawal by Subject |
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| parent not liking program |
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| BG002 | Unexposed Practice Group- Aim 1 Stakeholders | Coach stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football |
| BG003 | On-field Activity Group - Aim 3 Stakeholders | Coach stakeholders pilot tested the intervention |
| BG004 | 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 |
| BG005 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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
|
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| 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 | 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 | Posted | Mean | Standard Deviation | impacts per player per minute | Month 3 |
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| 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. | 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 | Posted | Mean | Standard Deviation | Impacts per athlete per practice | Month 3 |
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| 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. | 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 | Posted | Mean | Standard Deviation | Impacts/Athlete/ Practice | Month 3 |
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| 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. | 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 | Posted | Mean | Standard Deviation | g | Month 3 |
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| 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. | 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 | Posted | Mean | Standard Deviation | rad/s^2 | Month 3 |
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| 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. | 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 | Posted | Mean | Standard Deviation | rad/s | Month 3 |
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| 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. | 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 | Posted | Mean | Standard Deviation | g | Month 3 |
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| 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. | 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 | Posted | Mean | Standard Deviation | rad/s^2 | Month 3 |
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| 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. | 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 | Posted | Mean | Standard Deviation | rad/s | Month 3 |
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| 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 | No data collected for this outcome for the Unexposed Practice Group Stakeholders. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| Secondary | Acceptability of Intervention Measure (AIM) | total range 0 - 5 higher values denote better acceptability of the intervention (higher scores are better) | No data collected for this outcome for the Unexposed Practice Group Stakeholders. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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. | 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 | Posted | Number | percentage | Month 3 | Teams | Teams |
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| 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. | 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 | Posted | Number | number of adaptations | Month 3 | teams | teams |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | Data not collected from any athletes for this outcome because this task was inadvertently not included in the testing protocol. | Posted | Baseline and month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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 | Not Posted | Baseline and month 3 | Participants |
| 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 | Not Posted | Baseline and month 3 | Participants |
| 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 | Not Posted | Baseline and month 3 | Participants |
| 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 | Not Posted | Baseline and month 3 | Participants |
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | centimeters | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | centimeters | Month 3 |
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| 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) | 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 | Posted | Mean | Standard Deviation | T-score | Baseline |
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| 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 | 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 | Posted | Mean | Standard Deviation | T score | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | T-score | Month 3 |
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| 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 | 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 | Posted | Mean | Standard Deviation | T score | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | T score | Month 3 |
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| 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 | 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 | Posted | Mean | Standard Deviation | T score | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | T score | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | milliseconds | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | number items correct | Baseline |
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| 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 | 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. | Posted | Mean | Standard Deviation | number items correct | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
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| 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). | 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. | Posted | Mean | Standard Deviation | T score | Month 3 |
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| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | 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 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 | 0 | 34 | 0 | 34 | 0 | 34 |
| EG002 | Unexposed Practice Group- Aim 1 Stakeholders | Data from an unexposed sample | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | On-field Activity Group - Aim 3 Stakeholders | participation in this research will involve 4 to 12 visits and last about 1 hour per meeting over 4 to12 months - Participation in this study will involve discussion of biomechanical and video data with other stakeholders via semi-structured focus groups (coaches and parents) or individual interviews with league officials surrounding awareness and receptivity to creating a safer practice structure | 0 | 12 | 0 | 12 | 0 | 12 |
| EG004 | Unexposed Practice Group - Other Stakeholders | : Parent and organizational leader stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided