Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368050
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-11
Brief Title:
Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program COmmunities Aligned to reduce Concussion and Head impact exposure COACH on a larger scale Coaches of 12U 12 years old and under and 13U 13 years old and under teams within six youth football organizations will pilot test the intervention Aim 1 will conduct focus groups with coaches parents and organizational leaders to assess organizational needs capacity and readiness to adopt the intervention program Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success Aim 2 results intervention outcomes are reported herein
Detailed Description:
Coaches of teams at the 12U and 13U levels within the six youth football organizations will be invited to pilot test the intervention program Intervention outcomes will be compared to historic controls K25HD101686 - NCT04908930 Video taken at all practices will be used to monitor team activities of 12U and 13U teams across all organizations participating in the intervention incidence of injuries will be monitored across all teams Athletes n30 enrolled across two of six participating teams will be recruited to participate in parallel biomechanical and video data collection to evaluate the frequency and severity of head impacts experienced throughout the season Biomechanical data will be collected using instrumented mouth guards and verified with video Preliminary effectiveness will be measured by the percentage of coaches who choose to adopt and maintain the intervention program Head impact exposure and injury rates will be compared across the intervention and control teams
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None