Brain Concussion Clinical Trial
Official title:
The Effectiveness of Soccer Headgear to Reduce Concussion in Adolescents
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.
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.
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