N/A
Completed N=106
Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3
Head Injury · Sport Injury
Source: ClinicalTrials.gov NCT04908930 ↗
Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Number of Head Impacts — 100.24; 50.27 total number of practice impacts
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Head Impacts |
100.24; 50.27 | — |
| PRIMARY Number of Impacts Per Player Per Minute |
0.047; 0.026 | — |
| PRIMARY Mean Number of Impacts Per Athlete Per Practice |
4.75; 2.74 | — |
| PRIMARY 95th Percentile Number of Impacts Per Athlete Per Practice |
15.12; 10.12 | — |
| PRIMARY Median Linear Acceleration (g) |
9.63; 12.7 | — |
| PRIMARY Median Rotational Acceleration |
722.03; 1035.21 | — |
| PRIMARY Median Rotational Velocity |
9.03; 10.28 | — |
| PRIMARY 95th Percentile Linear Acceleration (g) |
25.8; 31.86 | — |
| PRIMARY 95th Percentile Rotational Acceleration |
2013.18; 2928.97 | — |
| PRIMARY 95th Percentile Rotational Velocity |
17.19; 21.21 | — |
| SECONDARY Feasibility of Intervention Measure (FIM) |
4.75; 4.41 | — |
| SECONDARY Acceptability of Intervention Measure (AIM) |
5; 4.54 | — |
| SECONDARY Percentage of Practices the Intervention Was Implemented as Prescribed |
41.7 | — |
| SECONDARY Number Changes to the Intervention |
— | — |
| SECONDARY Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing |
74.57; 79.10 | — |
| SECONDARY Visual Memory Composite Score (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing |
63.77; 69.79 | — |
| SECONDARY (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score |
27.61; 27.87 | — |
| SECONDARY (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score |
0.71; 0.70 | — |
| SECONDARY (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score |
11.80; 12.1 | — |
| SECONDARY Flanker - National Institutes of Health (NIH) Toolbox Flanker Inhibitory Control and Attention Test Score |
100.80; 98.19 | — |
| SECONDARY NIH Toolbox List Sorting Working Memory Test Score |
128.28; 104.95 | — |
| SECONDARY NIH Toolbox Picture Vocabulary Test Score |
92.52; 91.29 | — |
| SECONDARY NIH Toolbox Picture Sequence Memory Test Score |
— | — |
| SECONDARY Rey Auditory Verbal Learning Test Score (RAVLT) |
29.76; 25.71 | — |
| SECONDARY Postural Control - Anterior-Posterior Postural Sway Score |
— | — |
| SECONDARY Postural Control - Medial-Lateral Postural Sway Score |
— | — |
| SECONDARY Postural Control - Maximum Path Velocity Score |
— | — |
| SECONDARY Postural Control - Center of Pressure Area Score |
— | — |
| SECONDARY Vestibular/Ocular Motor Screening (VOMS) - Smooth Pursuits |
0.15; 0.06 | — |
| SECONDARY Vestibular/Ocular Motor Screening (VOMS) - Convergence |
0.35; 0.09 | — |
| SECONDARY Vestibular/Ocular Motor Screening (VOMS) - Horizontal Saccades |
0.16; 0.10 | — |
| SECONDARY Vestibular/Ocular Motor Screening (VOMS) - Visual Motion Sensitivity |
0.17; 0.10 | — |
| SECONDARY Vestibular/Ocular Motor Screening (VOMS) - Vertical Saccades |
0.15; 0.10 | — |
| SECONDARY Vestibular/Ocular Motor Screening (VOMS) - Horizontal Vestibular Ocular Reflex |
0.15; 0.10 | — |
| SECONDARY Vestibular/Ocular Motor Screening (VOMS) - Near Point Convergence |
6.00; 3.38 | — |
| SECONDARY Conners' Continuous Performance Test (CPT) - Reaction Speed |
51.48; 45.60 | — |
| SECONDARY Conners' Continuous Performance Test (CPT)) - Omissions |
64.46; 55.07 | — |
| SECONDARY Conners' Continuous Performance Test (CPT) - Omissions |
61.68; 52.30 | — |
| SECONDARY Conners' Continuous Performance Test (CPT) - Commissions |
50.56; 47.20 | — |
| SECONDARY Conners' Continuous Performance Test (CPT) - Perseverations |
68.48; 54.75 | — |
| SECONDARY Post Season (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Motor Composite Score |
30.79; 30.30 | — |
| SECONDARY NIH Toolbox Pattern Comparison Test Score |
106.12; 113.86 | — |
| SECONDARY (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score |
84.96; 81.62 | — |
| SECONDARY (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Visual Memory Composite Score |
73.76; 68.29 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04908930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.