Clinical Assessment of Sports Exertion

Return to Sport Clinical Trial

— CASE  

Official title:

Baylor Scott and White Sports Concussion Program Clinical Assessment of Sports Exertion Research Proposal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05013307
• Other study ID #: 021-143
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Baylor Research Institute
• Contact: Taylor Gilliland, MS
• Phone: 214-603-1527
• Email: taylor.gilliland[@]bswhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 22 Years

Eligibility

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)

Related Conditions & MeSH terms

• Return to Sport

Intervention

Other:
• CASE
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.

Locations

Country	Name	City	State
United States	Baylor Scott and White Sports Therapy and Research	Frisco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Sports Academy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate (bpm)	Using pulse oximeter placed on index finger heart rate will be recorded.	through study completion, an average of 1.5 hours
Primary	Blood pressure (mmHg)	Using a manual cuff and auscultation method diastolic and systolic scores will be recorded.	through study completion, an average of 1.5 hours
Primary	Oxygen Saturation (%)	Using pulse oximeter placed on index finger oxygen saturation will be recorded.	through study completion, an average of 1.5 hours
Primary	Rate of Perceived Exertion (Borg 6-20)	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
Primary	Self-rated lightheadedness (0-6)	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
Primary	Self-rated dyspnea (Modified Borg 0-10)	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
Primary	Heart rate reserve (peak-rest), beats/min-1	Using metabolic cart, heart rate reserve will be recorded via Garmin heart rate strap.	through study completion, an average of 1.5 hours
Secondary	Modified Post-Concussion Symptom Scale (PCSS) (0-6)	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