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Clinical Assessment of Sports Exertion (CASE)

Baylor Scott and White Health (BSWH) logo

Baylor Scott and White Health (BSWH)

Status

Active, not recruiting

Conditions

Return to Sport

Treatments

Other: CASE

Study type

Interventional

Funder types

Other

Identifiers

NCT05013307
021-143

Details and patient eligibility

About

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.

Enrollment

125 estimated patients

Sex

All

Ages

10 to 22 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

125 participants in 1 patient group

CASE
Experimental group
Description:
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.
Treatment:
Other: CASE

Trial contacts and locations

1

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Central trial contact

Taylor Gilliland, MS

Data sourced from clinicaltrials.gov

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