Effect of Soccer Head Gear to Reduce Concussions (Socheadgear)

January 8, 2019 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3050

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2281
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soccer head gear
Subjects who are wearing soccer head gear during the practices and games during the soccer season.
Other: Soccer head gear
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.
No Intervention: Control
Subjects who are not wearing soccer head gear during the practices and games during the soccer season.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number Sport Related Concussion injuries
Time Frame: 2 years
To determine if the number of SRC injuries in soccer players wearing HG is lower than soccer players who did not wear head gear (NoHG).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days of soccer participation lost due to Sport Related Concussion injuries
Time Frame: 2 years
To determine if the average number of days of soccer participation lost post Sport Related Concussion injury is different between soccer players in the HG group compared to players in the NoHG group.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Operating Committee on Standards for Athletic Equipment (NOCSAE)

Investigators

  • Principal Investigator: Timothy A McGuine, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSN186953

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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