Full 90 Headgear Research Paper

Full90 does not claim that its headgear prevents concussions. But the company does say the headgear can reduce, by up to 50 percent, the peak impact forces that occur during typical collisions when a player's head strikes another head, the ground, an elbow or a goal post.

The headgear debate is occurring at a time when some studies indicate that concussions occur in soccer at a rate similar to the rate in football.

There also is disagreement on whether heading the ball can cause concussions or long-term brain impairment. Studies have presented contradictory results, and the matter remains disputed as the soccer federation undertakes a long-term examination of head injuries.

The resolution of these head-related issues could have far-reaching health and financial impacts, given that nearly 18 million people play soccer in the United States.

On one side of the headgear argument is Jeff Skeen, founder of Full90. He said he developed the protective device after his daughter Lauren suffered two soccer-related concussions in high school, causing her to quit the sport.

At 46, Skeen possesses the righteousness of the aggrieved parent. He believes his product can reduce head injuries without giving an illicit advantage in heading the ball.

The soccer federation, which permits headgear but does not endorse it, fears that its wide use would undermine the assertion that soccer is a safe alternative to football, Skeen said. He likens the doubt of soccer officials to familiar but failed arguments once made against the use of bicycle helmets, automobile seat belts and soccer shin guards.

"They are trying to thwart the evolution of headgear in soccer because they think it will scare soccer moms away from the sign-up table," Skeen said of soccer federation officials. "And because they think it could be viewed as an admission that heading the ball itself is dangerous."

Calvin Williams, founder of the Kangaroo headgear company, said he thought soccer officials resisted the equipment because they felt "it is sissified."

Soccer federation officials disagree, saying their caution is based on scientific uncertainty.

Insufficient independent evidence exists to confirm that headgear can reduce the risk of head injuries, they say. Doctors affiliated with the federation also say that headgear is being marketed primarily to children, who least need them because there is little incidence of concussions in players under the age of 12.

Players might develop a false sense of security, relying on headgear instead of proper medical evaluation after suffering a concussion, federation doctors say. Or, they say, players might feel invincible in headgear and play with reckless aggressiveness, displaying behavior known as the Superman effect.

Rather than headgear, federation officials advocate better technique, stricter rules enforcement and improved officiating to reduce the number of head injuries. Some also recommend mouth guards and padded goal posts instead of padded headgear.

"There is no evidence headgear are going to help, and some theoretical stuff that it could hurt," said Dr. Gary Green, a clinical professor at the U.C.L.A. division of sports medicine who is on the soccer federation's medical advisory committee. "Why take a chance until this gets studied?"

Because Full90 pays some pro players (the equivalent of $50 to $100 per game, it says) and some state soccer associations ($4,000 to $10,000) to endorse its product, the soccer federation says the company's claims are suspect.

"We're talking about marketing and fear and manipulation," said Dr. Bert Mandelbaum, team physician for the United States national teams.

Not all medical soccer experts oppose headgear.

Dr. J. Scott Delaney of McGill University in Montreal said laboratory data, not yet published, does indicate that headgear could reduce impact forces by 10 to 30 percent. (The soccer federation says this involves low-level forces that don't cause concussions.) Delaney said an industry standard for headgear has been drafted and could be instituted in May.

In a study, published in the Clinical Journal of Sports Medicine, Delaney queried 328 Canadian university football players and 201 university soccer players as they reported to fall training camp in 1999. He found that 70.4 percent of the football players and 62.7 percent of the soccer players had experienced symptoms of a concussion in the previous year.

"We've shown concussions are a problem, and in the lab these things work," Delaney said of headgear. "What else do you need? Why wouldn't you start protecting people?"

Studies involving large numbers of players can occur only after headgear is used widely, said Delaney, who is team physician for the McGill soccer team and the Montreal Alouettes of the Canadian Football League.

The concern over concussions, and whether headgear can protect against them, is a growing issue for youth soccer associations. In September, the New York State West Youth Soccer Association, which governs more than 200 clubs and 80,000 youths in the Buffalo-Rochester area, voted to require headgear for all players under 14.

The association later retreated over concerns about liability and protests from some coaches and officials. Several coaches interviewed in Rochester wondered why headgear were proposed for young children and not for older teenagers, who are more likely to get concussions.

Others said risk was inherent in any sport.

"Where are you going to draw the line? Make everyone wear knee braces?" said Tom Maines, who coaches an under-10 boys team in Brockport, N.Y.

Some players resist headgear on aesthetic grounds.

"It looks goofy," said Brittany Myles, 13, of Syracuse.

Ross Paule, a midfielder for the Columbus Crew of Major League Soccer, wore Full90 headgear for a dozen games in the recently completed season, seeking some security after suffering three earlier concussions.

"I'm on the fence," said Paule, who was not paid to endorse the headgear. "I don't agree it should be mandated. If something makes you comfortable, why not?" He added: "I can't tell you if it was a huge help. When I got hit one time, maybe it gave me a little extra cushion."

Any club or association that makes headgear compulsory risks losing its affiliation with the United States Soccer Federation, Dr. S. Robert Contiguglia, its president, said.

But that threat is either unknown or ignored by the Temecula Valley Soccer Association in Southern California, which for three seasons has required headgear for players under 8. Peter Schilperoort, president of the association, said headgear prevented bumps and cuts previously suffered by his players, calling the equipment "the best thing since sliced bread."

The De Anza Force soccer club of Cupertino, Calif., will require headgear for players under 17 beginning in March, said Tom Pridham, a club official. Both the Temecula and De Anza clubs are sponsored by Full90.

Jerry Smith, coach of the Santa Clara women's team, which received free headgear from Full90, said the equipment made his players more confident in challenging balls in the air, and more assertive, but not overly so.

Anson Dorrance, who has coached the women's team at North Carolina to 18 national championships, said compulsory use of shin guards had not changed the nature of soccer, as many feared. He predicted that headgear would not, either.

"I'd challenge any of these doctors who feel this has no value to run into the goal post without a Full90 and with it, then tell me, if they were forced to do it a third time, whether or not they would wear it," said Dorrance, whose team is also sponsored by Full90.

Several players, including Joy Fawcett of the United States women's national team, who endorses Full90, discounted the so-called the Superman effect, saying the headgear did not make players dangerously aggressive.

"It's like a flag that reminds you not to go up for stupid plays," said Jill Conaboy, a defender at Downingtown West High in suburban Philadelphia, who wore headgear last weekend as her team won the Pennsylvania Class AAA state championship.

Kathy Conaboy, Jill's mother, said she held no illusion that her daughter, who has suffered two concussions, would never be hurt again while wearing headgear. What she hopes, she said, is that a blow that might have caused a third concussion will result in only a bruise.

"A seat belt is not going to save a life in a 90-mile-per-hour crash into a wall," Kathy Conaboy said. "A 30-mile-per-hour crash, a fender bender, it helps. I'm looking at this as a seat belt."

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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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