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:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT03865433
Eligibility Criteria:
Inclusion Criteria:
1. are aged 13-17, years and a high school student-athlete who attends school where an athletic trainer can supervise the exercise protocol;
2. have sustained a concussion within 2-7 days of clinic presentation and diagnosed by a study physician;
3. demonstrate symptom exacerbation during a graded treadmill exercise test and cannot complete the test;
4. are currently participating in a school or club sport;
5. are English speaking and capable of giving assent
Exclusion Criteria:
1. have a reported history of neurological condition or disorder including but not limited to brain surgery, special education, seizure disorder, speech pathology, previous diagnosis of Post-Concussion Syndrome (PCS),
2. are unwilling to exercise,
3. have focal neurologic deficit that would represent risk for walking/running on treadmill,
4. exhibit an inability to exercise due to injury, known heart disease, or increased cardiac risk,
5. have experienced more than 3 previous concussions,
6. have suffered a substantial comorbidity (eg,cervical injury),
7. currently taking β-blockers, calcium channel blockers, or prophylactic headache medications (e.g., amitriptyline, topiramate), or
8. have a resting blood pressure of \> 140/90.
9. If the potential participant or parent/guardian is unable to fully understand the study protocol or study risks due to injury or developmental delay, the potential participant will be excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT03865433
Study Brief:
Protocol Section:
NCT03865433