Status:
COMPLETED
Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Head Injury
Sport Injury
Eligibility:
All Genders
11-14 years
Phase:
NA
Brief Summary
Two middle school (ages 11-14) football teams will be in Aim 1 of this study. All interested athletes on these teams will be invited to voluntarily participate in biomechanical data collection; of tho...
Detailed Description
This study hypothesizes that (a) determinants at the individual (athlete), interpersonal (team \& coach), and community levels (built \& social environment) of the social ecological model may be ident...
Eligibility Criteria
Inclusion
- All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months.
Exclusion
- Athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04908930
Start Date
July 8 2021
End Date
November 29 2023
Last Update
February 27 2025
Active Locations (1)
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1
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States, 27157