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

Sport Injury Clinical Trial

Official title:

Community-Engaged Sport Safety - Aim 1 and Aim 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908930
• Other study ID #: IRB00067187
• Secondary ID: K25HD101686
• Status: Completed
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: November 29, 2023

Study information

• Verified date: March 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 29, 2023
• Est. primary completion date: October 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Athletic Injuries
• Craniocerebral Trauma
• Head Injury
• Sport Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Head Impacts	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.	Month 3
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Median rotational acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.	Month 3
Primary	Median rotational velocity	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.	Month 3
Primary	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
Primary	95th percentile rotational acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration.	Month 3
Primary	95th percentile rotational velocity	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity.	Month 3
Secondary	Feasibility of Intervention Measure (FIM)	Perceived feasibility - higher values denote better feasibility - total range 0 - 5	Fall season, up to 13 weeks
Secondary	Acceptability of Intervention Measure (AIM)	Higher values denote better acceptability - total range 0 - 5	Fall season, up to 13 weeks
Secondary	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
Secondary	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
Secondary	(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better	Baseline and month 3
Secondary	(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better	Baseline and month 3
Secondary	(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-100; higher scores are better	Baseline and month 3
Secondary	(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-1; lower scores are better	Baseline and month 3
Secondary	(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score	ImPACT is a computerized neuropsychological test battery. Participants will complete a pre-season baseline assessment which will be compared to post-season assessment scores - 0-40; lower scores are better	Baseline and month 3
Secondary	Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 70-120; higher scores are better	Baseline and month 3
Secondary	NIH Toolbox List Sorting Working Memory Test Score	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Sequence Memory - 70-120; higher scores are better	Baseline and month 3
Secondary	NIH Toolbox Picture Vocabulary Test Score	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Vocabulary - 70-120; higher scores are better	Baseline and month 3
Secondary	NIH Toolbox Picture Sequence Memory Test Score	Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Picture Sequence Memory - 70-120; higher scores are better	Baseline and month 3
Secondary	Rey Auditory Verbal Learning Test Score (RAVLT)	The RAVLT assesses verbal learning ability - A series of 15 words is presented to the participant 3 times via audio recording for standardization, and answers are recorded - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-15; higher scores are better	Baseline and month 3
Secondary	Postural Control - Anterior-Posterior Postural Sway Score	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better	Baseline and month 3
Secondary	Postural Control - Medial-Lateral Postural Sway Score	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-50; lower scores are better	Baseline and month 3
Secondary	Postural Control - Maximum Path Velocity Score	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-10; lower scores are better	Baseline and month 3
Secondary	Postural Control - Center of Pressure Area Score	Participants will complete two 30-second trials (one with eyes opened, one with eyes closed) while standing on a force plate - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - 0-20; lower scores are better	Baseline and month 3
Secondary	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
Secondary	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
Secondary	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
Secondary	Vestibular/Ocular Motor Screening (VOMS) - Convergence	The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times 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
Secondary	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
Secondary	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
Secondary	Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence	The participant will be asked to focus on a small target and slowly bring it to the tip of their nose until two distinct images of the target are seen. The participant will complete this three times and scores will be averaged over three trials - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - Rates changes in symptoms on 0 - 15; lower scores are better	Baseline and month 3
Secondary	Conners' Continuous Performance Test (CPT) - Reaction Speed	Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Reaction Speed T score; 0-100; lower scores are better	Baseline and month 3
Secondary	Conners' Continuous Performance Test (CPT) - Omissions	Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Ommissions T score; 0-100; lower scores are better	Baseline and month 3
Secondary	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
Secondary	Conners' Continuous Performance Test (CPT) - Perseverations	Participants will complete a 14-minute computer-based assessment that evaluates selective, sustained and divided attention, as well as impulsivity and vigilance - Participants will complete a preseason baseline assessment which will be compared to post-season assessment scores - CPT Perseverations T score; 0-100; lower scores are better	Baseline and month 3