Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT05373992
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects
* Age 12-17 years of age presenting to the Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) concussion clinic in Plano, Texas, to be treated for a diagnosed SRC
* Patients who suffered a sport-related concussion within 72-hours of first clinic visit
Exclusion Criteria:
* Patients who suffered a sport-related concussion outside of 72-hours of first clinic visit
* Is not diagnosed with a SRC
* Is already taking part in another study that measures their physical activity, sleep, screen-time, or is related to concussion
* Has a current diagnosis of and treatment with medication for attention deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions (because these factors are associated with delayed recovery
* Has a co-existing musculoskeletal injury that may impact their ability to be physically active during recovery
* Has an increased cardiac event risk according to the American College of Sports Medicine criteria
* Has a symptom severity score of less than 5 points on the post-concussion symptom scale during the initial clinical examination
* Has an ability to exercise to exhaustion without symptom provocation during the initial clinical examination
* Has limited English language proficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT05373992
Study Brief:
Protocol Section:
NCT05373992