Principal Investigator: Timothy A. McGuine PhD ATC, Senior Scientist (PI)
Institution: University of Wisconsin School of Medicine and Public Health
Title: The Effectiveness of Soccer Headgear to Reduce the Incidence or Severity of Sport Related Concussion in Adolescents
Abstract: High school soccer is a very popular sport, with over one million male and female participants annually nationwide. An estimated 87,000 Sport Related Concussions (SRC) occur in U.S. high school soccer athletes each year. Despite the high incidence of SRC in this population, little is known about equipment that is being marketed to players and coaches with claims that it reduces a player’s susceptibility to SRC. There have been no prospective randomized, controlled trials to examine the effect of soccer headgear on the incidence and severity of SRC in high school soccer players. The proposed study will fill this important gap by evaluating the effectiveness of soccer headgear in reducing the risk of SRC in high school adolescent soccer players.
Aims: To determine if protective soccer headgear reduces the incidence or severity of SRC in high school soccer players.
Study Design: Cluster randomized control trial.
Materials and Methods: A minimum of N = 2,940 high school soccer players (male and female, age 14-18, grades 9 – 12) from 84 Wisconsin high schools will be enrolled as subjects in this study. All subjects will complete a baseline questionnaire to provide information on their age, competition level, number of years playing competitive soccer, previous history of SRC and a 22 item Concussion Symptom Scale. Subjects in schools randomly assigned to the intervention group (n = 1470, 42 schools) will be required to wear the protective soccer head gear (Full90 Premier Headgear) for all practice and competitions throughout their competitive soccer season. Subjects in the control group will be allowed to practice and compete without the protective head gear. Licensed athletic trainers (LATs) at each participating school will electronically report all SRC injury and athletic exposure (AE) data on weekly basis to the study team. At the conclusion of the data collection, the rate of SRCs will be estimated using Kaplan and Meier survival analysis and compared between the intervention and control group using a log-rank test. Cox Proportional Hazards modeling will be utilized to examine the relationship between SRCs and the independent variables (age, sex, competition level and previous SRC history). Wilcoxon Rank Sum tests will be used to determine if there was a significant difference in the injury severity between the intervention and control subjects. All analyses will control for school cluster effect and will be performed at the threshold of α = 0.05.
Main Outcome Measures:
- The incidence (number of SRC’s per 1000 AE)
- The severity (days lost due to injury)
Significance: This study will provide the first rigorous, scientific evidence to guide clinical recommendations to soccer players, parents, coaches and medical providers regarding use of protective headgear to reduce the risk of SRC.