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Physical Performance Assessment for Safe Return to Sport (CASE Trial)
N/A
Recruiting
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1.5 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial assesses an athlete's physical performance in response to dynamic exertion, in order to identify system impairments that may keep them from safely returning to their sport.
Who is the study for?
This trial is for athletes aged 10-22 who've had a concussion but are symptom-free at rest and cleared to play within the last 30 days. They must have played organized sports in the past year. It's not for those with severe brain injuries, cardiopulmonary conditions, certain mental health diagnoses, more than three concussions, diabetes, uncontrolled asthma, pregnancy or current COVID-19 symptoms.
What is being tested?
The CASE test measures an athlete's physical response during sport-specific activities to help decide if they're ready to return to sports after a concussion. It looks at physiological and symptomatic responses across various body positions typical of different sports like soccer and basketball.
What are the potential side effects?
Since CASE is an exercise-based assessment rather than a drug treatment, there aren't traditional side effects. However, it may provoke symptoms in recovering athletes which can inform healthcare professionals about their readiness to resume sporting activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1.5 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1.5 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood pressure (mmHg)
Heart rate (bpm)
Heart rate reserve (peak-rest), beats/min-1
+4 moreSecondary study objectives
Modified Post-Concussion Symptom Scale (PCSS) (0-6)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CASEExperimental Treatment1 Intervention
In this prospective study the investigators aim to quantify participants' responses to physical activity. Participants will be asked to engage in physical activity, to identify any provocation of symptoms in adolescents ranging from ages 10 to 22 years. Responses to physical activity will be measured through physiologic markers (e.g., blood pressure, heart rate, oxygen saturation, rate of perceived exertion, dyspnea). Additionally, participants will be monitored for any changes in symptoms that occur during or after physical activity as measured by the modified PCSS symptom inventory.
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Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
206 Previous Clinical Trials
203,300 Total Patients Enrolled
Sports AcademyUNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of heart or lung problems.You are currently taking medication for attention-deficit/hyperactivity disorder, learning disorder, depression, or anxiety, or have had more than three concussions in the past.You have physical limitations due to orthopedic, neurological, or other issues.You are pregnant.You have reported experiencing at least one symptom during the initial assessment.You are taking medication for issues related to a previous concussion.You have a medical condition that causes symptoms similar to a concussion, like chronic headaches or active migraines.You are either currently showing symptoms of COVID-19 or have had symptoms within the last week.You have had a serious head injury in the past that caused a score of 12 or less on the Glasgow Coma Scale.You have asthma that is not well controlled.You have a history of seizures.You have difficulty speaking or understanding English.You are currently taking medication to prevent blood clots or reduce the risk of heart attacks and strokes.You have been diagnosed with a concussion using the international concussion in sport group criteria.
Research Study Groups:
This trial has the following groups:- Group 1: CASE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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