None listed
Conditions
Brief summary
This study will test whether GameGear Nodal Impact Attenuation soft padded headgear can reduce the risk and severity of concussion in collision-sport athletes. Players from participating teams in Victoria, Queensland and the ACT will take part in a randomised crossover trial, in which they will wear the headgear during some matches and not wear it during others. We will compare concussion rates and concussion severity between these two conditions. If a participating player sustains a suspected concussion during a match, they will undergo specialist clinical review and provide a blood sample to measure biomarkers of brain injury. A smaller subgroup of players will also wear instrumented mouthguards during selected matches to measure head impacts, and will provide additional blood samples after non-injury matches to help assess the biological effects of head impacts when playing with and without headgear. The study aims to improve understanding of whether this headgear provides meaningful protection in real-world sport and to help guide safer sporting practices.
Interventions
GameGear Nodal Impact Attenuation padded headgear: All participants allocated to the intervention will wear the same model of commercially manufactured GameGear Nodal Impact Attenuation padded headgear, with size adjusted for individual fit. Headgear will be fitted pre-season by research staff, and participants will be encouraged to trial the headgear during at least one training session before match use to confirm comfort and fit. Headgear use is randomised at the team-week level within a rando
GameGear Nodal Impact Attenuation padded headgear: All participants allocated to the intervention will wear the same model of commercially manufactured GameGear Nodal Impact Attenuation padded headgear, with size adjusted for individual fit. Headgear will be fitted pre-season by research staff, and participants will be encouraged to trial the headgear during at least one training session before match use to confirm comfort and fit. Headgear use is randomised at the team-week level within a randomised crossover design. Over one competitive season, participants will contribute up to five headgear-ON and five headgear-OFF match exposures, subject to match participation and availability. During allocated headgear-ON matches, the headgear is intended to be worn for the full duration of the match unless discontinued earlier because of discomfort or fit issues. Match duration is expected to range from approximately 80 to 140 minutes depending on the code and competition. Adherence will be supported by issue of headgear in allocated headgear-ON matches and assessed by post-match verification of compliance using match recordings/video review, supplemented by team records and participant post-match questionnaires. A subset of up to 150 participants will also take part in the instrumented mouthguard component. These participants will undergo a dental scan by a licensed dental technician to produce a custom-fit Nexus Gen III instrumented mouthguard, will be asked to trial the mouthguard during training before study commencement, and will wear it during matches across one season to record head impact kinematics. The instrumented mouthguard subgroup will be recruited from selected teams based on logistical feasibility and to support appropriate sport, sex and age representation. Within these teams, eligible consenting participants may elect to take part in the mouthguard component. Eligibility for the mouthguard component includes having stable dentition suitable for mouthguard fitting, and excludes individuals with active orthodontic treatment that result in ongoing tooth movement during the study period.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants are athletes aged 16 years and over who are coach-nominated first-team players from recruited teams in participating collision-sport competitions, and who provide written informed consent to participate. Participating teams must have appropriate match-day staff and routine match video capture/filmed matches to support study procedures. For participants aged 16–17 years, parental/guardian written consent and participant assent are required
Exclusion criteria
Key exclusion criteria are: concussion within the previous 6 months; history of moderate to severe brain injury; medical conditions that may contribute to neurological impairment (e.g. epilepsy, significant cognitive impairment, structural brain abnormality, multiple sclerosis or dementia); pregnancy or breastfeeding; current anticoagulant or antiplatelet use; venepuncture not feasible; and regular or intended use of protective headgear during the study period. For the instrumented mouthguard subgroup only, exclusion criteria also include current or permanent dental or orthodontic appliances affecting the upper dentition (e.g. braces)
Outcome results
None listed