- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013307
Clinical Assessment of Sports Exertion (CASE)
February 6, 2026 updated by: Baylor Research Institute
Baylor Scott and White Sports Concussion Program Clinical Assessment of Sports Exertion Research Proposal
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Frisco, Texas, United States, 75034
- Baylor Scott and White Sports Therapy and Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 22 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CASE
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.
|
The Clinical Assessment for Sports Exertion (CASE) addresses the physical performance of athletes by quantifying physiological and symptomatic responses to dynamic exertion.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate (bpm)
Time Frame: through study completion, an average of 1.5 hours
|
Using pulse oximeter placed on index finger heart rate will be recorded.
|
through study completion, an average of 1.5 hours
|
|
Blood pressure (mmHg)
Time Frame: through study completion, an average of 1.5 hours
|
Using a manual cuff and auscultation method diastolic and systolic scores will be recorded.
|
through study completion, an average of 1.5 hours
|
|
Oxygen Saturation (%)
Time Frame: through study completion, an average of 1.5 hours
|
Using pulse oximeter placed on index finger oxygen saturation will be recorded.
|
through study completion, an average of 1.5 hours
|
|
Rate of Perceived Exertion (Borg 6-20)
Time Frame: through study completion, an average of 1.5 hours
|
Using Borg Scale, self report measure of exertion will be recorded.
A higher number indicates higher exertion.
|
through study completion, an average of 1.5 hours
|
|
Self-rated lightheadedness (0-6)
Time Frame: through study completion, an average of 1.5 hours
|
On a scale of 0-6, a self report measure of lightheadedness will be recorded.
A higher number indicates worse lightheadedness.
|
through study completion, an average of 1.5 hours
|
|
Self-rated dyspnea (Modified Borg 0-10)
Time Frame: through study completion, an average of 1.5 hours
|
Using Borg scale, self report measure of dyspnea will be recorded.
A higher number indicates worse dyspnea.
|
through study completion, an average of 1.5 hours
|
|
Heart rate reserve (peak-rest), beats/min-1
Time Frame: through study completion, an average of 1.5 hours
|
Using metabolic cart, heart rate reserve will be recorded via Garmin heart rate strap.
|
through study completion, an average of 1.5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Post-Concussion Symptom Scale (PCSS) (0-6)
Time Frame: through study completion, an average of 1.5 hours
|
Using modified PCSS, self report measure of symptoms will be recorded.
A high number indicates worse symptoms.
|
through study completion, an average of 1.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
August 4, 2021
First Submitted That Met QC Criteria
August 18, 2021
First Posted (Actual)
August 19, 2021
Study Record Updates
Last Update Posted (Actual)
February 10, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 021-143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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