CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
On-field activity group - Aim 3behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04908930
NCT04908930N/ACompleted

Community-Engaged Sport Safety - Aim 1 and Aim 3

Wake Forest University Health Sciences·interventional·Posted Jun 1, 2021·Updated Feb 27, 2025

In Brief

A clinical study evaluating On-field activity group - Aim 3 for Head Injury and Sport Injury. Completed, enrolled 106 participants across 1 site.

Detailed 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 those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. In aim 3, two youth football teams at the middle school level will be recruited to pilot an intervention developed this study. The football coaches of each team will be prospectively recruited and enrolled. All interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. Baseline and post-season neurocognitive data will be collected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 1, 2021
Enrollment StartJul 8, 2021
Primary CompletionOct 22, 2023
Study CompletionNov 29, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.1 years ago

Interventions

On-field activity group - Aim 3behavioral

Athletes of two new teams at the middle school level to pilot the practice structure intervention and continuously monitor on-field activity with head impact sensors to evaluate the feasibility, acceptability, and sustainability of the practice structure