NCT02850926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,050

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

July 25, 2016

Last Update Submit

January 8, 2019

Conditions

Brain Concussion

Keywords

ConcussionSoccerAdolescent

Outcome Measures

Primary Outcomes (1)

  • The number Sport Related Concussion injuries

    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 Outcomes (1)

  • Number of days of soccer participation lost due to Sport Related Concussion injuries

    2 years

Study Arms (2)

Soccer head gear

EXPERIMENTAL

Subjects who are wearing soccer head gear during the practices and games during the soccer season.

Other: Soccer head gear

Control

NO INTERVENTION

Subjects who are not wearing soccer head gear during the practices and games during the soccer season.

Interventions

Soccer head gearOTHER

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.

Soccer head gear

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705-2281, United States

Location

Related Publications (1)

  • 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.

    PMID: 31088784DERIVED

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Timothy A McGuine, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 1, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

US(1)