Comparing two tests for concussion recovery in adolescents
Comparing Symptom Provocation and Physiological Response Between Buffalo Concussion Treadmill Test (BCTT) Protocol and Modified Dynamic Exertion Test (mEXiT) Post Concussion
This study is trying to see if two different tests for concussion recovery can help teenagers aged 14-17 feel better and recover faster after a sports-related injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 14 Years to 17 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06276660 on ClinicalTrials.gov |
What this trial studies
This study compares the Buffalo Concussion Treadmill Test (BCTT) and the Modified Dynamic Exertion (mEXiT) test to assess symptom provocation and physiological responses in adolescents aged 14-17 who have suffered a sport-related concussion. Participants will be randomly assigned to one of the two tests within 14 days of their injury, and their symptoms, heart rate, and perceived exertion will be monitored throughout the testing process. The goal is to determine if there are significant differences in recovery time and symptom response between the two testing methods.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 14-17 who have been diagnosed with a sport-related concussion within 14 days of injury.
Not a fit: Patients who have been medically cleared from a previous concussion within the past 6 months or have a history of multiple concussions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective recovery protocols for adolescents with concussions.
How similar studies have performed: While the BCTT is a well-established method, the mEXiT test is a newer approach, making this study a novel exploration in concussion recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
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 worse by physical activity * Been told by a doctor to only conduct physical activity under medical supervision.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC/Univ of Pgh Sports Medicine Concussion Research Program — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Anthony P Kontos, PhD — University of Pittsburgh
- Study coordinator: Anthony P Kontos, PhD
- Email: akontos@pitt.edu
- Phone: 412-904-1298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.