Clinical Assessment of Sports Exertion (NCT05013307) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Assessment of Sports Exertion
United States125 participantsStarted 2021-08-07
Plain-language summary
The Clinical Assessment for Sports Exertion (CASE) addresses the physical performance of athletes by quantifying physiological and symptomatic responses to dynamic exertion. The CASE is highly sport-specific as it tests multiple body positions that mimic requirements typical of individual and contact sports activities including soccer, gymnastics, cheerleading, swimming, and basketball. It was developed by clinicians at the Baylor Scott and White Sports Concussion Program in an effort to identify specific system impairments in athletes who were unable to successfully demonstrate readiness for return to play protocols. Like the other published forms of concussion exertion testing described above, the CASE is a provocative exercise test that may also prove to be useful in making informed return-to-play decisions based upon the athlete's symptomatology.
Who can participate
Age range
10 Years – 22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart rate (bpm)
Timeframe: through study completion, an average of 1.5 hours
2
Blood pressure (mmHg)
Timeframe: through study completion, an average of 1.5 hours
3
Oxygen Saturation (%)
Timeframe: through study completion, an average of 1.5 hours
4
Rate of Perceived Exertion (Borg 6-20)
Timeframe: through study completion, an average of 1.5 hours
5
Self-rated lightheadedness (0-6)
Timeframe: through study completion, an average of 1.5 hours
6
Self-rated dyspnea (Modified Borg 0-10)
Timeframe: through study completion, an average of 1.5 hours
7
Heart rate reserve (peak-rest), beats/min-1
Timeframe: through study completion, an average of 1.5 hours