Clinical trial NCT02850926: Effect of Soccer Head Gear to Reduce Concussions
Official title: The Effectiveness of Soccer Headgear to Reduce Concussion in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: Concussion
Soccer
Adolescent
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Operating Committee on Standards for Athletic Equipment (NOCSAE)
First posted: 2016-08-01
Enrollment: 3050
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* be a member on one (freshman, junior varsity or varsity) of the schools interscholastic soccer teams
* be in grades 9 to 12,
* be able to fully participate (no disabling injuries) in team activities on the day of pre-season team practices
* athlete and parent (when appropriate) sign the mandated University of Wisconsin Research Informed Assent/Consent and HIPAA Research Forms.

Exclusion Criteria:

* are not a member of the schools interscholastic soccer (freshman, junior varsity or varsity) teams,
* are not in grades 9 to 12,
* the athlete or parent (when appropriate) does not sign the mandated University of Wisconsin Research Informed Assent/Consent and HIPAA Research Forms.

Primary outcomes:
measure: The number Sport Related Concussion injuries
timeFrame: 2 years
Secondary outcomes:
measure: Number of days of soccer participation lost due to Sport Related Concussion injuries
timeFrame: 2 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy A McGuine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGuine T, Post E, Pfaller AY, Hetzel S, Schwarz A, Brooks MA, Kliethermes SA. Does soccer headgear reduce the incidence of sport-related concussion? A cluster, randomised controlled trial of adolescent athletes. Br J Sports Med. 2020 Apr;54(7):408-413. doi: 10.1136/bjsports-2018-100238. Epub 2019 May 14.