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Behavioural Intervention

Modified EXiT Test (mEXiT) for Concussion

N/A
Recruiting
Led By Anthony P Kontos, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 baseline (60-90 minutes), participants only complete one visit
Awards & highlights

Study Summary

"This trial aims to compare two different tests, the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test, for adolescents aged

Who is the study for?
This trial is for adolescents aged 14-17 who have been diagnosed with a sport-related concussion within the last two weeks. They must be referred to exertion therapy by a clinician from UPMC Sports Medicine Concussion Program after certain tests and interviews.Check my eligibility
What is being tested?
The study compares two types of physical tests: Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT). It looks at how these tests provoke symptoms, affect heart rate, and perceived effort in young athletes post-concussion.See study design
What are the potential side effects?
Since this trial involves exercise testing rather than medication, side effects may include temporary increases in concussion symptoms like headache or dizziness during or after the test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 baseline (60-90 minutes), participants only complete one visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 baseline (60-90 minutes), participants only complete one visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Physiological response to dynamic or aerobic test (HEART RATE)
Secondary outcome measures
Blood Pressure
Clinical Profiles Screening (CP-Screen)
Generalized Anxiety Disorder (GAD-7)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Modified EXiT Test (mEXiT)Experimental Treatment1 Intervention
Participants 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.
Group II: Buffalo Concussion Treadmill Test (BCTT)Active Control1 Intervention
Participants 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.

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Who is running the clinical trial?

University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,307,373 Total Patients Enrolled
Anthony P Kontos, PhDPrincipal InvestigatorUniversity of Pittsburgh
4 Previous Clinical Trials
227 Total Patients Enrolled
~36 spots leftby Sep 2024
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