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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06368050
Other study ID # IRB00067187.2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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
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