Head InjuryNCT04908930
Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3
A study testing On-field activity group - Aim 3 in people with Head Injury and Sport Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Two middle school (ages 11-14) football teams will be in Aim 1 of this study. All interested athletes on these teams will be invited to voluntarily participate in biomechanical data collection; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Injury, Sport Injury
- What is being tested?
- On-field activity group - Aim 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2021to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months.
Who cannot join
- Athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Community-Engaged Sport Safety - Aim 1 and Aim 3
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.
Read the detailed description
This study hypothesizes that (a) determinants at the individual (athlete), interpersonal (team \& coach), and community levels (built \& social environment) of the social ecological model may be identified and targeted to reduce head impact exposure in youth football practices, and (b) an evidence-based strategy to reduce head impact exposure in practices may be developed and pilot tested using a community-engaged approach.
- Conditions
- Head Injury, Sport Injury
- Being tested
- On-field activity group - Aim 3
- Keywords
- Sport Safety, Youth Football, Head Impact Exposure
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-field activity group - Aim 3Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: On-field activity group - Aim 3 |
| 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 Receives: Behavioral: On-field activity group - Aim 3 |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 3
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 3
Secondary outcomes (51)
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
Measured: Month 3
Acceptability of Intervention Measure (AIM)
total range 0 - 5 higher values denote better acceptability of the intervention (higher scores are better)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start8 Jul 2021
- Primary completion22 Oct 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- All interested football players on the 2 teams will be enrolled; will be randomly selected for instrumentation with head impact sensors using a random numbers table. Athletes on these teams will follow their coach prescribed practice structure. Two additional youth football teams at the middle school level will be recruited to pilot test the intervention developed in this study. All interested athletes on these teams will be enrolled; will be randomly selected for instrumentation with head impact sensors using a random numbers table. Enrolled athletes will wear head impact sensors embedded in a custom mouthpiece that will be used to collect head impact exposure in conjunction with on-field video data for the season.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jill Urban, PhD, MPH, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908930
- Sponsor's protocol ID
- IRB00067187
- Other IDs
- K25HD101686
- Status last verified
- Mar 2023
- First submitted
- 17 May 2021
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant Data and Study Protocol
Publications
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.
PubMed 39351080
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Engaged Sport Safety - Aim 1 and Aim 3
- ClinicalTrials.gov ID
- NCT04908930
- Acronym / sponsor ID
- IRB00067187
- Conditions
- Head Injury, Sport Injury
- Keywords
- Sport Safety, Youth Football, Head Impact Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 22 Oct 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 27 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two middle school (ages 11-14) football teams will be in Aim 1 of this study. All interested athletes on these teams will be invited to voluntarily participate in biomechanical data collection; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. In aim 3, two youth football teams at the middle school level will be recruited to pilot an intervention developed this study. The football coaches of each team will be prospectively recruited and enrolled. All interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. Baseline and post-season neurocognitive data will be collected.
Detailed description
This study hypothesizes that (a) determinants at the individual (athlete), interpersonal (team \& coach), and community levels (built \& social environment) of the social ecological model may be identified and targeted to reduce head impact exposure in youth football practices, and (b) an evidence-based strategy to reduce head impact exposure in practices may be developed and pilot tested using a community-engaged approach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- All interested football players on the 2 teams will be enrolled; will be randomly selected for instrumentation with head impact sensors using a random numbers table. Athletes on these teams will follow their coach prescribed practice structure. Two additional youth football teams at the middle school level will be recruited to pilot test the intervention developed in this study. All interested athletes on these teams will be enrolled; will be randomly selected for instrumentation with head impact sensors using a random numbers table. Enrolled athletes will wear head impact sensors embedded in a custom mouthpiece that will be used to collect head impact exposure in conjunction with on-field video data for the season.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: On-field activity group - Aim 3Athletes 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 | 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 | Behavioral: On-field activity group - Aim 3coaches 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 |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months.
Key exclusion criteria (1 listed)
- Athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-field activity group - Aim 3Athletes 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 | Behavioural | On-field activity group - Aim 3, On-field activity group - Aim 3 Stakeholders |
Primary outcome
Number of Head Impacts
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
Number of Impacts Per Player Per Minute
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. Number of impacts per player per minute
Mean Number of Impacts Per Athlete Per Practice
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
95th Percentile Number of Impacts Per Athlete Per Practice
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.
Median Linear Acceleration (g)
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.
Median Rotational Acceleration
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.
Median Rotational Velocity
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.
95th Percentile Linear Acceleration (g)
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration.
95th Percentile Rotational Acceleration
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration.
95th Percentile Rotational Velocity
Time frame: Month 3
Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity.
51 secondary outcomes
Feasibility of Intervention Measure (FIM)
Time frame: Month 3
Acceptability of Intervention Measure (AIM)
Time frame: Month 3
Percentage of Practices the Intervention Was Implemented as Prescribed
Time frame: Month 3
Number Changes to the Intervention
Time frame: Month 3
Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing
Time frame: Baseline
Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing
Time frame: Baseline
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score
Time frame: Baseline
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score
Time frame: Baseline
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score
Time frame: Baseline
Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score
Time frame: Baseline
Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score
Time frame: Month 3
NIH Toolbox List Sorting Working Memory Test Score
Time frame: Baseline
NIH Toolbox List Sorting Working Memory Test Score
Time frame: Month 3
NIH Toolbox Picture Vocabulary Test Score
Time frame: Baseline
NIH Toolbox Picture Sequence Memory Test Score
Time frame: Baseline and month 3
NIH Toolbox Picture Vocabulary Test Score
Time frame: Month 3
Rey Auditory Verbal Learning Test Score (RAVLT)
Time frame: Baseline
Rey Auditory Verbal Learning Test Score (RAVLT)
Time frame: Month 3
Postural Control - Anterior-Posterior Postural Sway Score
Time frame: Baseline and month 3
Postural Control - Medial-Lateral Postural Sway Score
Time frame: Baseline and month 3
Postural Control - Maximum Path Velocity Score
Time frame: Baseline and month 3
Postural Control - Center of Pressure Area Score
Time frame: Baseline and month 3
Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits
Time frame: Baseline
Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits
Time frame: Month 3
Vestibular/Ocular Motor Screening (VOMS) - Convergence
Time frame: Month 3
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades
Time frame: Baseline
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades
Time frame: Month 3
Vestibular/Ocular Motor Screening (VOMS) - Convergence
Time frame: Baseline
Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity
Time frame: Baseline
Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades
Time frame: Baseline
Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades
Time frame: Month 3
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex
Time frame: Baseline
Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity
Time frame: Month 3
Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence
Time frame: Baseline
Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence
Time frame: Month 3
Conners' Continuous Performance Test (CPT) - Reaction Speed
Time frame: Baseline
Conners' Continuous Performance Test (CPT)) - Omissions
Time frame: Baseline
Conners' Continuous Performance Test (CPT) - Omissions
Time frame: Month 3
Conners' Continuous Performance Test (CPT) - Commissions
Time frame: Baseline
Conners' Continuous Performance Test (CPT) - Commissions
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39351080Urban 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.
- Individual participant dataSharing planned: Yes. Participant Data and Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Urban, PhD, MPH principal investigator
Wake Forest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-field activity group - Aim 3 in people with Head Injury and Sport Injury, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Head Impacts (time frame: Month 3). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.