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On-field activity group for Sports Injuries

N/A
Waitlist Available
Led By Jill Urban, PhD, MPH
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights

Study Summary

This trial will involve two middle school football teams, with data being collected on 15-20 randomly selected players from each team. The aim is to develop an intervention to improve player safety, with data being collected before and after the season to measure any changes.

Eligible Conditions
  • Sports Injuries
  • Traumatic Brain Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
All athletes on the teams can take part in the study, even if they have had braces for more than 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
95th percentile linear acceleration
95th percentile number of impacts
95th percentile rotational acceleration
+7 more
Secondary outcome measures
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Impulse Control Composite Score
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Reaction Time Composite Score
(ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing - Verbal Memory Composite Score
+26 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: On-field activity group - Aim 3Experimental Treatment1 Intervention
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
Group II: Unexposed practice group- Aim 1Active Control1 Intervention
Data from an unexposed sample (football players practicing as they would otherwise).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
On-field activity group - Aim 3
2021
N/A
~50

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,231 Previous Clinical Trials
1,001,766 Total Patients Enrolled
Jill Urban, PhD, MPHPrincipal InvestigatorWake Forest Health Sciences

Media Library

On-field activity group - Aim 3 Clinical Trial Eligibility Overview. Trial Name: NCT04908930 — N/A
Sports Injuries Research Study Groups: Unexposed practice group- Aim 1, On-field activity group - Aim 3
Sports Injuries Clinical Trial 2023: On-field activity group - Aim 3 Highlights & Side Effects. Trial Name: NCT04908930 — N/A
On-field activity group - Aim 3 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908930 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current total of patients actively involved in this trial?

"Affirmative. Per the data accessible on clinicaltrials.gov, this medical trial is currently recruiting participants and was first posted on July 8th 2021. The study needs to enrol 60 patients from one location with the most recent update made April 29th 2022."

Answered by AI

Is there availability for patient recruitment to this clinical research initiative?

"This investigation, which was first publicly posted on the 8th of July 2021 is currently enrolling patients. Subsequent updates to the listing have been made as recently as April 29th 2022."

Answered by AI

Is this clinical trial accessible to those aged 45 and above?

"The primary boundaries for enrolment set by this trial are ages 11 to 14. In comparison, there are 129 trials available to minors and 598 geared towards patients aged 65 or above."

Answered by AI

What primary goals is this clinical trial aiming to accomplish?

"This month-long trial is measuring the average number of impacts as its primary outcome. Secondary outcomes include assessing smooth pursuits with VOMS, changes in symptom severity from a 0 to 10 scale, acceptability of intervention on a range from 0 to 5, and Impulse Control Composite Score based off ImPACT assessment results which are measured on a 0 to 40 scale; lower scores being more favourable."

Answered by AI

What qualifications must a participant fulfill to join this experiment?

"This research is focussed on recruiting sixty young athletes between the ages of 11 to 14 who have sustained a sports-related injury. To be eligible, all prospective participants must satisfy the criteria that they are currently registered with a team and any orthotic device in use must have been worn for over 6 months consecutively."

Answered by AI
~13 spots leftby Mar 2025