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

Mild Traumatic Brain Injury Clinical Trial

Official title: Comparing Symptom Provocation and Physiological Response Between Buffalo Concussion Treadmill Test (BCTT) Protocol and Modified Dynamic Exertion Test (mEXiT) Post Concussion

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The Buffalo Concussion Treadmill Test is a well established test to determine intensity of exercise without significant symptoms provocation after sport related concussion.

This study will help determine if there is a difference in type of symptom response between the two tests, due to the dynamic changes of direction and strain on the vestibular system with the m-EXiT group. The investigators hypothesize there will not be a significant difference between the two groups in time to clearance to return to sport despite allowing for higher symptoms earlier on in recovery.

High school athletes who have been diagnosed with a sport-related concussion will be randomly assigned to complete either the BCTT or the modified dynamic EXiT test (m-EXiT). The BCTT group will follow the established protocol and exercise to an increase of 2/10 symptoms on a visual analog scale (VAS) or 17/20 on rate of perceived effort (RPE) scale. The m-EXiT test will complete a shortened version of the dynamic EXiT test, but will stop if participants have an increase of greater than 4 points of headache, dizziness or nausea or RPE of 17/20. Symptoms, heart rate, and RPE will be measured through out both tests as well as Post-Concussion Symptom Scale (PCSS), Vestibular Ocular Motors Screening (VOMS), blood pressure and heart rate will be administered before and after testing. The time (in days) to recovery, will also be recorded from the medical record to determine if there is a difference between the two groups.

The primary outcome for the study will be symptoms post test and heart rate. Secondary measures include: Post Concussion Symptom Score (PCSS), Clinical Profiles Screening (CP-Screen), Vestibular Ocular Motor Screening (VOMS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder - 7 (GAD-7) and blood pressure. These will be collected at one visit with participants, there are no follow-up or subsequent visits for this study. ;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

• NCT number: NCT06276660
• Study type: Interventional
• Source: University of Pittsburgh
• Contact: Anthony P Kontos, PhD
• Phone: 412-904-1298
• Email: akontos@pitt.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Completion date: December 31, 2024