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Mild Traumatic Brain InjuryNCT06276660

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

A study testing BCTT and Dynamic ExIT in people with Mild Traumatic Brain Injury, run by University of Pittsburgh at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 14 to 17 years
Conditions the study is for
Mild Traumatic Brain Injury
What is being tested?
BCTT and Dynamic ExIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
5 Mar 2024to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC/Univ of Pgh Sports Medicine Concussion Research Program

    Pittsburgh, Pennsylvania, 15203

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
BCTT, Dynamic ExIT
Keywords
mtbi, concussion, exertion therapy
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCTTOther

    Participants will complete the Buffalo Concussion Treadmill Test, which involves individuals walking at 5.8 km/hr. (3.6 mph) at a 0.0% incline (5.1 km/hr. [3.2 mph] if below 5' 10" tall), the treadmill incline is increased 1 degree each minute for the first 15 minutes, then speed increased 0.64 km/hr. (0.4 mph) each minute thereafter.

  • Dynamic ExITOther

    The modified EXiT test will complete a 12 minute treadmill interval program followed by a dynamic circuit (10 squat jumps, 10 side to side push ups and 10 medicine ball rotations), jump ball toss, zig zag agility and arrow agility. Parameters will be recorded the same as the established dynamic EXiT test; heart rate and RPE will be recorded at 0, 2, 6:30 and 12 minutes of the treadmill program as well as after the second trial of each activity. The time to complete two trials of the zig zag agility and arrow agility will also be recorded.

Study groups in NCT06276660
Study groupRoleWhat they receive
Buffalo Concussion Treadmill Test (BCTT)Active comparatorParticipants in this group will complete the Buffalo Concussion Treadmill Test (BCTT). This involves individuals walking at 5.8 km/hr. (3.6 mph) at a 0.0% incline (5.1 km/hr. [3.2 mph] if below 5' 10" tall), the treadmill incline is increased 1 degree each minute for the first 15 minutes, then speed increased 0.64 km/hr. (0.4 mph) each minute thereafter.
Receives: Other: BCTT
Modified EXiT Test (mEXiT)ExperimentalParticipants in this group will complete the modified EXiT test (mEXiT). Participants will complete a 12 minute treadmill interval program followed by a dynamic circuit (10 squat jumps, 10 side to side push ups and 10 medicine ball rotations), jump ball toss, zig zag agility and arrow agility. Parameters will be recorded the same as the established dynamic EXiT test; heart rate and RPE will be recorded at 0, 2, 6:30 and 12 minutes of the treadmill program as well as after the second trial of each activity. The time to complete two trials of the zig zag agility and arrow agility will also be recorded.
Receives: Other: Dynamic ExIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physiological response to dynamic or aerobic test (HEART RATE)

    Participants will have their heart rate taken before the exercise protocol, then monitored throughout the test and after they complete the BCTT or mEXiT.

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

  2. Physiological response to dynamic or aerobic test (SYMPTOM PROVOCATION)

    Participants will report on a Likert scale ranging from 0-10 (10 being severe) for headache, dizziness, and nausea, and provide a rating of perceived exertion (RPE) on a Borg scale ranging from 6 to 20 before and after completion of the BCTT or mEXiT.

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

Secondary outcomes (6)

  1. Post Concussion Symptom Scale

    Participants rate on a 7 point Likert scale the presence and severity of 22 common concussion-related symptoms, including, but not limited to headache, dizziness, confusion, fogginess. The scale is 0-6 (0=none, 1-2=mild, 3-4=moderate, 5-6=severe). Higher the score, the more symptoms participant is reporting.

    Measured: Visit 1 Baseline (60-90 minutes), participants only complete one visit

  2. Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is a 9 item questionnaire that assesses the presence and severity of depression over the last 2-weeks. Total score ranges from 1-27, with higher scores indicating higher level of depression. Scale is 0-4 (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day). Higher scores indicate worse reporting of issues.

    Measured: Visit 1 Baseline (60-90 minutes), participants only complete one visit

  3. Generalized Anxiety Disorder (GAD-7)

    The GAD-7 is a seven item self-reported questionnaire that measures severity of symptoms regarding anxiety. Responses are 0 = not at all, 1 = several days, 2= more than half the days, and 3 = nearly every day. Higher scores are indicative of higher anxiety (0-4 = minimal anxiety, 5-9= mild anxiety, 10-14 =moderate anxiety, 15-21 = severe anxiety (higher scores indicate higher level of reported anxiety).

    Measured: Visit 1 Baseline (60-90 minutes), participants only complete one visit

  4. Vestibular Ocular Motor Screening (VOMS)

    Participants will complete a VOMS assessment which will take approximately 5 minutes. Prior to screening, the participant reports baseline symptoms (headache, dizziness, nausea, fogginess) on a scale from 0 to 10. Then the participant performs different eye movements that include: smooth pursuits, saccades (horizontal \& vertical), convergence, vestibular ocular reflex (VOR [horizontal \& vertical]), visual motor sensitivity (VMS) and again rates his/her symptoms (headache, dizziness, nausea, fogginess) on a Likert scale from 0 to 10. Abnormal findings or provocation of symptoms with any test may indicate dysfunction. This will be completed by a clinician or researcher. This procedure will be repeated after BCTT and mEXiT protocol on the same day. Higher scores indicate worse symptoms.

    Measured: Visit 1 Baseline (pre and post testing 60-90 minutes), participants only complete one visit

  5. Clinical Profiles Screening (CP-Screen)

    The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2) cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors, sleep and cervical. Patients rate the severity of their symptoms as none = 0, mild = 1, moderate = 2, or severe =3. Scores are totaled across the clinical profiles and symptom modifiers. The measure also yields a CP-Screen total raw score ranging from (0-87) with higher scores reflecting more symptoms.

    Measured: Visit 1 Baseline (60-90 minutes), participants only complete one visit

  6. Blood Pressure

    Participants blood pressure will be taken same-day, before and after the BCTT or mEXiT test (both systolic and diastolic BP will be recorded with all measurements).

    Measured: Visit 1 Baseline (pre and post testing 60-90 minutes), participants only complete one visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start5 Mar 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06276660
Sponsor's protocol ID
STUDY23070079
Status last verified
Feb 2026
First submitted
6 Feb 2024
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data may be shared with other researchers who sent a request to to the study investigators. The data can be used for any analysis purpose, including publications or presentations. After de-identification, all of the individual participant data collected during the trial will be available for sharing.

Questions about this trial

What is this clinical trial studying?

A study testing BCTT and Dynamic ExIT in people with Mild Traumatic Brain Injury, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physiological response to dynamic or aerobic test (HEART RATE) (time frame: Visit 1 (baseline) (pre, during, and post testing) 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06276660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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