Trial Outcomes & Findings for Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3 (NCT NCT04908930)
NCT ID: NCT04908930
Last Updated: 2025-02-27
Results Overview
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
COMPLETED
NA
106 participants
Month 3
2025-02-27
Participant Flow
Participant milestones
| Measure |
Unexposed Practice Group- Aim 1
Data from an unexposed sample (football players practicing as they would otherwise).
|
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
|
Unexposed Practice Group- Aim 1 (Stakeholders)
Coach stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football
|
On-field Activity Group - Aim 3 (Stakeholders)
Coach stakeholders pilot tested the intervention
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
6
|
12
|
18
|
|
Overall Study
COMPLETED
|
30
|
25
|
6
|
12
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Unexposed Practice Group- Aim 1
Data from an unexposed sample (football players practicing as they would otherwise).
|
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
|
Unexposed Practice Group- Aim 1 (Stakeholders)
Coach stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football
|
On-field Activity Group - Aim 3 (Stakeholders)
Coach stakeholders pilot tested the intervention
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
hardware in mouth
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
wrong team
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
quit team
|
2
|
4
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
parent not liking program
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3
Baseline characteristics by cohort
| Measure |
Unexposed Practice Group- Aim 1
n=36 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=34 Participants
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
|
Unexposed Practice Group- Aim 1 Stakeholders
n=6 Participants
Coach stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football
|
On-field Activity Group - Aim 3 Stakeholders
n=12 Participants
Coach stakeholders pilot tested the intervention
|
Unexposed Practice Group - Other Aim Stakeholders
n=18 Participants
Parent and organizational leader stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
12.4 years
STANDARD_DEVIATION 0.55 • n=5 Participants
|
12.5 years
STANDARD_DEVIATION 0.82 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
39.0 years
STANDARD_DEVIATION 6.7 • n=21 Participants
|
12.4 years
STANDARD_DEVIATION 0.70 • n=8 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
96 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
87 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: 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
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Number of Head Impacts
|
100.24 total number of practice impacts
Standard Deviation 81.06
|
50.27 total number of practice impacts
Standard Deviation 39.57
|
PRIMARY outcome
Timeframe: Month 3Population: 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
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Number of Impacts Per Player Per Minute
|
0.047 impacts per player per minute
Standard Deviation 0.03
|
0.026 impacts per player per minute
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Month 3Population: 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
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Mean Number of Impacts Per Athlete Per Practice
|
4.75 Impacts per athlete per practice
Standard Deviation 3.35
|
2.74 Impacts per athlete per practice
Standard Deviation 2.03
|
PRIMARY outcome
Timeframe: Month 3Population: 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
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
95th Percentile Number of Impacts Per Athlete Per Practice
|
15.12 Impacts/Athlete/ Practice
Standard Deviation 10.73
|
10.12 Impacts/Athlete/ Practice
Standard Deviation 5.95
|
PRIMARY outcome
Timeframe: Month 3Population: 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
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Median Linear Acceleration (g)
|
9.63 g
Standard Deviation 2.05
|
12.7 g
Standard Deviation 3.74
|
PRIMARY outcome
Timeframe: Month 3Population: 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
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Median Rotational Acceleration
|
722.03 rad/s^2
Standard Deviation 295.31
|
1035.21 rad/s^2
Standard Deviation 451.41
|
PRIMARY outcome
Timeframe: Month 3Population: 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
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Median Rotational Velocity
|
9.03 rad/s
Standard Deviation 2.25
|
10.28 rad/s
Standard Deviation 3.25
|
PRIMARY outcome
Timeframe: Month 3Population: 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
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
95th Percentile Linear Acceleration (g)
|
25.8 g
Standard Deviation 6.83
|
31.86 g
Standard Deviation 10.46
|
PRIMARY outcome
Timeframe: Month 3Population: 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
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
95th Percentile Rotational Acceleration
|
2013.18 rad/s^2
Standard Deviation 1014.19
|
2928.97 rad/s^2
Standard Deviation 1340.6
|
PRIMARY outcome
Timeframe: Month 3Population: 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
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=33 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
95th Percentile Rotational Velocity
|
17.19 rad/s
Standard Deviation 2.89
|
21.21 rad/s
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: Month 3Population: No data collected for this outcome for the Unexposed Practice Group Stakeholders.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=6 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=12 Participants
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
|
|---|---|---|
|
Feasibility of Intervention Measure (FIM)
|
4.75 score on a scale
Standard Deviation 0.18
|
4.41 score on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Month 3Population: No data collected for this outcome for the Unexposed Practice Group Stakeholders.
total range 0 - 5 higher values denote better acceptability of the intervention (higher scores are better)
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=6 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=12 Participants
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
|
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
|
5 score on a scale
Standard Deviation 0
|
4.54 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Month 3Population: 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
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=2 Teams
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
|
|---|---|---|
|
Percentage of Practices the Intervention Was Implemented as Prescribed
|
—
|
41.7 percentage
|
SECONDARY outcome
Timeframe: Month 3Population: 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
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=2 teams
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
|
|---|---|---|
|
Number Changes to the Intervention
|
—
|
0 number of adaptations
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing
|
74.57 score on a scale
Standard Deviation 14.2
|
79.10 score on a scale
Standard Deviation 11.18
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing
|
63.77 score on a scale
Standard Deviation 14.87
|
69.79 score on a scale
Standard Deviation 13.24
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score
|
27.61 score on a scale
Standard Deviation 7.82
|
27.87 score on a scale
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score
|
0.76 milliseconds
Standard Deviation 0.11
|
0.72 milliseconds
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score
|
12.17 score on a scale
Standard Deviation 11.44
|
11.17 score on a scale
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score
|
93.2 score on a scale
Standard Deviation 20.98
|
91.24 score on a scale
Standard Deviation 16.77
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score
|
100.80 score on a scale
Standard Deviation 18.67
|
98.19 score on a scale
Standard Deviation 22.26
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
NIH Toolbox List Sorting Working Memory Test Score
|
105.77 score on a scale
Standard Deviation 14.82
|
103.76 score on a scale
Standard Deviation 15.99
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
NIH Toolbox List Sorting Working Memory Test Score
|
128.28 score on a scale
Standard Deviation 14.58
|
104.95 score on a scale
Standard Deviation 17.45
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
NIH Toolbox Picture Vocabulary Test Score
|
91.89 score on a scale
Standard Deviation 16.06
|
92.28 score on a scale
Standard Deviation 11.68
|
SECONDARY outcome
Timeframe: Baseline and month 3Population: Data not collected from any athletes for this outcome because this task was inadvertently not included in the testing protocol.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3Population: 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.
Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
NIH Toolbox Picture Vocabulary Test Score
|
92.52 score on a scale
Standard Deviation 14.95
|
91.29 score on a scale
Standard Deviation 11.18
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Rey Auditory Verbal Learning Test Score (RAVLT)
|
22.06 score on a scale
Standard Deviation 6.29
|
23.28 score on a scale
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Rey Auditory Verbal Learning Test Score (RAVLT)
|
29.76 score on a scale
Standard Deviation 5.58
|
25.71 score on a scale
Standard Deviation 7.44
|
SECONDARY outcome
Timeframe: Baseline and month 3Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and month 3Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and month 3Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-10; lower scores are better
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and month 3Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-20; lower scores are better
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits
|
0.25 score on a scale
Standard Deviation 0.76
|
0.11 score on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits
|
0.15 score on a scale
Standard Deviation 0.49
|
0.06 score on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Convergence
|
0.13 score on a scale
Standard Deviation 0.39
|
0.10 score on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades
|
0.30 score on a scale
Standard Deviation 0.78
|
0.12 score on a scale
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades
|
0.16 score on a scale
Standard Deviation 0.48
|
0.10 score on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Convergence
|
0.35 score on a scale
Standard Deviation 0.85
|
0.09 score on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity
|
0.37 score on a scale
Standard Deviation 0.89
|
0.10 score on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades
|
0.34 score on a scale
Standard Deviation 0.84
|
0.12 score on a scale
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades
|
0.15 score on a scale
Standard Deviation 0.49
|
0.10 score on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex
|
0.29 score on a scale
Standard Deviation 0.80
|
0.13 score on a scale
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity
|
0.17 score on a scale
Standard Deviation 0.52
|
0.10 score on a scale
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence
|
6.48 centimeters
Standard Deviation 5.71
|
2.97 centimeters
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence
|
6.00 centimeters
Standard Deviation 4.92
|
3.38 centimeters
Standard Deviation 4.96
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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
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)
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=28 Participants
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
|
|---|---|---|
|
Conners' Continuous Performance Test (CPT) - Reaction Speed
|
55.34 T-score
Standard Deviation 11.77
|
47.00 T-score
Standard Deviation 9.50
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=28 Participants
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
|
|---|---|---|
|
Conners' Continuous Performance Test (CPT)) - Omissions
|
64.46 T score
Standard Deviation 16.7
|
55.07 T score
Standard Deviation 14.99
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=20 Participants
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
|
|---|---|---|
|
Conners' Continuous Performance Test (CPT) - Omissions
|
61.68 T-score
Standard Deviation 16.23
|
52.30 T-score
Standard Deviation 12.04
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=28 Participants
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
|
|---|---|---|
|
Conners' Continuous Performance Test (CPT) - Commissions
|
52.57 T score
Standard Deviation 7.93
|
50.14 T score
Standard Deviation 8.15
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=20 Participants
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
|
|---|---|---|
|
Conners' Continuous Performance Test (CPT) - Commissions
|
50.56 T score
Standard Deviation 8.69
|
47.20 T score
Standard Deviation 8.82
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=28 Participants
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
|
|---|---|---|
|
Conners' Continuous Performance Test (CPT) - Perseverations
|
67.74 T score
Standard Deviation 18.71
|
58.00 T score
Standard Deviation 14.82
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=20 Participants
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
|
|---|---|---|
|
Conners' Continuous Performance Test (CPT) - Perseverations
|
68.48 T score
Standard Deviation 18.98
|
54.75 T score
Standard Deviation 16.46
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score
|
30.79 score on a scale
Standard Deviation 7.48
|
30.30 score on a scale
Standard Deviation 8.70
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score
|
0.71 milliseconds
Standard Deviation 0.12
|
0.70 milliseconds
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score
|
11.80 score on a scale
Standard Deviation 9.65
|
12.1 score on a scale
Standard Deviation 13.13
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=35 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=29 Participants
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
|
|---|---|---|
|
NIH Toolbox Pattern Comparison Test Score
|
91.03 number items correct
Standard Deviation 26.49
|
102.10 number items correct
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
NIH Toolbox Pattern Comparison Test Score
|
106.12 number items correct
Standard Deviation 19.78
|
113.86 number items correct
Standard Deviation 27.89
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score
|
84.96 score on a scale
Standard Deviation 10.98
|
81.62 score on a scale
Standard Deviation 15.04
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score
|
73.76 score on a scale
Standard Deviation 10.28
|
68.29 score on a scale
Standard Deviation 16.35
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=21 Participants
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
|
|---|---|---|
|
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex
|
0.15 score on a scale
Standard Deviation 0.46
|
0.10 score on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Month 3Population: 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.
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).
Outcome measures
| Measure |
Unexposed Practice Group- Aim 1
n=25 Participants
Data from an unexposed sample (football players practicing as they would otherwise).
|
On-field Activity Group - Aim 3
n=20 Participants
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
|
|---|---|---|
|
Conners' Continuous Performance Test (CPT) - Reaction Speed
|
51.48 T score
Standard Deviation 11.33
|
45.60 T score
Standard Deviation 4.42
|
Adverse Events
Unexposed Practice Group- Aim 1
On-field Activity Group - Aim 3
Unexposed Practice Group- Aim 1 Stakeholders
On-field Activity Group - Aim 3 Stakeholders
Unexposed Practice Group - Other Stakeholders
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jillian Urban, PhD
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place