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

Community-Engaged Sport Safety - Aim 1 and Aim 3

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.

Study Overview

• Status: Completed
• Conditions: Head Injury; Sport Injury
• Intervention / Treatment: Behavioral: On-field activity group - Aim 3

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Urban, PhD, MPH; Phone Number: (336) 716-0947; Email: jurban@wakehealth.edu
• Study Contact Backup: Name: Konstantia Strates; Phone Number: 336-713-1263; Email: kcstrate@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months.

Exclusion Criteria:

• Athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Unexposed practice group- Aim 1; Data from an unexposed sample (football players practicing as they would otherwise).
Experimental: 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	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Head Impacts	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.	Month 3
Impact rate	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.	Month 3
Mean number of impacts	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.	Month 3
95th percentile number of impacts	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.	Month 3
Median linear acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.	Month 3
Median rotational acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.	Month 3
Median rotational velocity	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.	Month 3
95th percentile linear acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration.	Month 3
95th percentile rotational acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration.	Month 3
95th percentile rotational velocity	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure (FIM)	Perceived feasibility - higher values denote better feasibility - total range 0 - 5	Fall season, up to 13 weeks
Acceptability of Intervention Measure (AIM)	Higher values denote better acceptability - total range 0 - 5	Fall season, up to 13 weeks
Number of times the intervention was implemented as prescribed	The extent to which the intervention was implemented as prescribed. Descriptive data and inferential statistics will be used. Common themes will be grouped, and qualitative data indexed and charted.	Fall season, up to 13 weeks
Number changes to the intervention	Descriptive data and inferential statistics will be used. Common themes will be grouped, and qualitative data indexed and charted.	Fall season, up to 13 weeks
(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	Baseline and 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	Baseline and month 3
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better	Baseline and 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	Baseline and 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 - 0-40; lower scores are better	Baseline and month 3
Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better	Baseline and 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 - Picture Sequence Memory - 70-120; higher scores are better	Baseline and month 3
NIH Toolbox Picture Vocabulary Test Score	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better	Baseline and month 3
NIH Toolbox Picture Sequence Memory Test Score	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Sequence Memory - 70-120; higher scores are better	Baseline and month 3
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 - 0-15; higher scores are better	Baseline and month 3
Postural Control - Anterior-Posterior Postural Sway Score	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better	Baseline and month 3
Postural Control - Medial-Lateral Postural Sway Score	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better	Baseline and month 3
Postural Control - Maximum Path Velocity Score	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-10; lower scores are better	Baseline and month 3
Postural Control - Center of Pressure Area Score	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-20; lower scores are better	Baseline and month 3
Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits	The participant will be asked to focus on a small target 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 - 10; lower scores are better	Baseline and month 3
Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades	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 - 10; lower scores are better	Baseline and month 3
Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades	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 - 10; lower scores are better	Baseline and 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 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 - 10; lower scores are better	Baseline and month 3
Vestibular/Ocular Motor Screening (VOMS) - Horizontal vestibular ocular reflex	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 - 10; lower scores are better	Baseline and month 3
Vestibular/Ocular Motor Screening (VOMS) - Visual motion sensitivity	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 - 10; lower scores are better	Baseline and month 3
Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence	The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 15; lower scores are better	Baseline and 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 T score; 0-100; lower scores are better	Baseline and month 3
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 Ommissions T score; 0-100; lower scores are better	Baseline and month 3
Conners' Continuous Performance Test (CPT) - Commissions	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 Commission T score; 0-100; lower scores are better	Baseline and 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 T score; 0-100; lower scores are better	Baseline and month 3

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Jill Urban, PhD, MPH, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Actual): October 22, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Sport Safety; Youth Football; Head Impact Exposure
• Additional Relevant MeSH Terms: Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma; Athletic Injuries
• Other Study ID Numbers: IRB00067187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant Data and Study Protocol
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Individual participant data (IPD) collected in this study be shared using the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system. The NIH FITBIR database is a data sharing resource for the TBI imaging research field. Data sharing forms will be used to upload biomechanical data and associated metadata according to the NINDS/DoD Biomechanical Devices in TBI Common Data Elements (CDE). All data summarized in publications will also be made available upon email request to the study PI and upon completion of a data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No