Assessment of athletes' readiness to return to sports after concussion
Baylor Scott and White Sports Concussion Program Clinical Assessment of Sports Exertion Research Proposal
This study tests a new way to see if athletes who had concussions are ready to safely return to their sports by measuring how they perform during specific exercises.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 10 Years to 22 Years |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (Frisco, Texas) |
| Trial ID | NCT05013307 on ClinicalTrials.gov |
What this trial studies
The Clinical Assessment for Sports Exertion (CASE) evaluates the physical performance of athletes recovering from concussions by measuring their physiological and symptomatic responses during sport-specific exertion tests. This assessment is tailored to various sports, including soccer, gymnastics, cheerleading, swimming, and basketball, and aims to identify specific impairments that may affect an athlete's readiness to return to play. Conducted by clinicians at the Baylor Scott and White Sports Concussion Program, the CASE serves as a provocative exercise test to inform return-to-play decisions based on the athlete's symptoms and performance.
Who should consider this trial
Good fit: Ideal candidates are athletes aged 10-22 who have been diagnosed with a concussion and cleared for return-to-play by a healthcare professional.
Not a fit: Patients with orthopedic or neurologic limitations, uncontrolled asthma, or other specified medical conditions may not benefit from this assessment.
Why it matters
Potential benefit: If successful, this assessment could enhance the safety and effectiveness of return-to-play protocols for athletes recovering from concussions.
How similar studies have performed: Other studies have shown success with similar exertion testing approaches for concussion recovery, indicating potential effectiveness of this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 10-22 years of age who have participated in organized sport activities within the past 12 months * Diagnosed with a concussion according to international concussion in sport group criteria * Asymptomatic at rest and must be cleared from return-to-play by a qualified healthcare professional no later than 30 days following clearance Exclusion Criteria: * Orthopedic or neurologic, or other limitations * History of seizures * Previous or current diagnoses for cardiopulmonary conditions * Medical diagnosis of diabetes and/or currently on medications for diabetes (e.g., insulin) * Uncontrolled asthma * Pregnancy * Currently experiencing symptoms of COVID-19 or \< 7 days since last symptoms * History of moderate or severe traumatic brain injury defined as a brain injury with an associated Glasgow Coma Scale score of 12 or less * Symptom score \>1 point on initial PCSS intake * A current diagnosis of and treatment with medication for attention-deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions * Limited English proficiency * Currently taking prescription medication for concussion related impairments * Anticoagulant or antiplatelet use * History of a medical condition that mimics the signs and symptoms of prolonged concussion symptoms (eg, history of chronic headaches, active migraines, cardiovascular conditions)
Where this trial is running
Frisco, Texas
- Baylor Scott and White Sports Therapy and Research — Frisco, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Taylor Gilliland, MS
- Email: taylor.gilliland@bswhealth.org
- Phone: 214-603-1527
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.