Active — Not RecruitingNot Applicable

Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test

United States60 participantsStarted 2024-03-05

Plain-language summary

This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit.

Who can participate

Age range

14 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with a sport related concussion within 14 days of injury * Participants referred to exertion therapy after a trained clinician from University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program has interpreted neurocognitive, vestibular, and clinical interview outcomes and determined the participant is capable of completing structured exercise. Exclusion Criteria: * Medically cleared from a previous concussion within the past 6 months * More than 2 previous concussions (excluding current injury) * History of brain surgery or traumatic brain injury (TBI) (based on Glasgow Coma Scale of \<13) * History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations) * Current history of pre-existing vestibular disorder or oculomotor condition * Currently taking antidepressant, anticoagulant, beta-blocker, or anticonvulsant prescription medications * Incapable of treadmill running up to 5.5 miles per hour (mph) and 4.5 mph for males and females respectively (self-reported). * Diagnosed with a cardiac, peripheral, or cerebrovascular disease (type 1 or 2 diabetes, or renal disease. * Experienced chest pain or shortness of breath while at rest or with mild exertion. * Lose balance because of dizziness or have lost consciousness (aside from concussion) from exertion * Currently have (or have had within the past 12 months) a bone, joint, or soft tissue (muscle, ligament, or tendon) problem that could be made w…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physiological response to dynamic or aerobic test (HEART RATE)

Timeframe: Visit 1 (baseline) (pre, during, and post testing) 90 minutes

Physiological response to dynamic or aerobic test (SYMPTOM PROVOCATION)

Timeframe: Visit 1 (baseline) (pre and post testing) 90 minutes

Trial details

NCT IDNCT06276660

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials