Effect of Soccer Head Gear to Reduce Concussions
Condition: Brain Concussion
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      This study will determine if protective soccer headgear reduces the incidence or severity of
      Sport Related Concussion injuries (SRCs) in US adolescent (high school) soccer players. Half
      the subjects will practice and play during their soccer season with soccer head gear
      specifically marketed to reduce the incidence of SRCs while the other half of the subjects
      will practice and play without the head gear.
    

Detailed description: 
      High school soccer is a very popular sport, with over one million male and female
      participants nationwide each year. Approximately 109,000 Sport Related Concussion SRCs were
      sustained by U.S. high school soccer players last year.

      Despite the high incidence of SRCs in this population, little is known about the type of
      protective head gear that is being marketed to players and coaches to prevent SRCs. There are
      conflicting lab studies that show players may or may not be protected from sustaining a SRC
      while wearing head gear. However, there have been no large, prospective, randomized trials to
      examine the effect of soccer headgear on the incidence and severity of SRC in high school
      soccer players.

      Approximately 3,000 high school soccer players (male and female, age 14-18, grades 9 - 12)
      from 88 United States high schools (44 per year) will be enrolled as subjects. All subjects
      will be asked to complete a short baseline survey regarding their previous history of SRCs.
      Schools will be randomly assigned to be in the head gear (intervention) group or no head gear
      (control) group. Subjects in schools assigned to the intervention group (n = 1500, 44
      schools) will be asked to wear the protective soccer head gear provided by the study team for
      all practices and games throughout their high school soccer season. Subjects in the control
      group schools (n = 1500, 44 schools) will be allowed to practice and compete as they normally
      would (without head gear). Licensed athletic trainers (ATs) employed at each participating
      school will electronically record and report the characteristics of all SRCs that are
      sustained by the subjects as well as their athletic exposures 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.
    

Intervention name(s): Soccer head gear
Intervention type(s): Other
Intervention description(s): Each head gear model consists of lightweight materials with a cross strap design that is fully adjustable or a single elastic headband. All models meet or exceed the American Society for Testing and Materials (ASTM) testing standards for soccer headgear and are approved by the National Federation of High Schools and The Fédération Internationale de Football Association (FIFA) for use by interscholastic soccer players. Players will be allowed to choose the brand of head gear to use and wear it for each practice and game during the soccer season.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Concussion; Soccer; Adolescent