Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football

Sport Injury Clinical Trial

Official title:

Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368050
• Other study ID #: IRB00067187.2
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Jill Urban, PhD, MPH
• Phone: 336.716.0947
• Email: jurban[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (n=30) 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Athletic Injuries
• Craniocerebral Trauma
• Head Injury
• Sport Injury
• Wounds and Injuries

Intervention

Behavioral:
• practice structure intervention
practice structure intervention

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Childress Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of practice head impacts	Number of verified direct head impacts measured in practice over the entire season.	Month 3
Primary	Number of practice head acceleration events	Number of verified direct and indirect head acceleration events measured in practice over the entire season.	Month 3
Primary	Practice head impact rate	Rate of verified direct head impacts per athlete per practice	Month 3
Primary	Practice head acceleration even rate	Rate of verified direct and indirect head acceleration events per athlete per practice	Month 3
Primary	Median linear acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.	Month 3
Primary	Median rotational acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.	Month 3
Primary	Median rotational velocity	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity	Month 3
Primary	95th percentile linear acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration	Month 3
Primary	95th percentile rotational acceleration	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration	Month 3
Primary	95th percentile rotational velocity	Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity	Month 3
Secondary	Feasibility of Intervention Measure (FIM) Values	Perceived feasibility - higher values denote better feasibility - total range 0 - 5	up to 13 weeks
Secondary	Acceptability of Intervention Measure (AIM) Values	Higher values denote better acceptability - total range 0 - 5	up to 13 weeks
Secondary	Number of practices the intervention was implemented as prescribed	The extent to which the intervention was implemented as prescribed. Descriptive data and inferential statistics will be used. Common themes will be grouped, and qualitative data indexed and charted	up to 13 weeks
Secondary	Average minutes per practice of live time	Minutes per practice spent on live tackling	up to 13 weeks