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On-field activity group for Sports Injuries
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.
- Sports Injuries
- Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- If you have had braces for less than 6 months, you cannot participate in the study.All athletes on the teams can take part in the study, even if they have had braces for more than 6 months.
- Group 1: Unexposed practice group- Aim 1
- Group 2: On-field activity group - Aim 3
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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