Physical Performance Assessment for Safe Return to Sport

(CASE Trial)

Overseen By Taylor Gilliland, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Must not be taking: Insulin, Anticoagulants, Antiplatelets, others

Disqualifiers: Seizures, Cardiopulmonary, Diabetes, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how athletes recover from concussions and determine when they can safely return to sports. Researchers use a special test called CASE (Clinical Assessment for Sports Exertion) to measure the body's response to physical activity, focusing on sports like soccer, gymnastics, and basketball. The goal is to identify any lingering issues in athletes cleared to play again after a concussion. The trial seeks athletes aged 10 to 22 who have had a concussion, are now symptom-free at rest, and have been cleared by a healthcare professional to resume sports within the last 30 days. As an unphased trial, this study offers athletes the chance to contribute to important research that could improve concussion recovery protocols.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop certain medications. The trial excludes participants who are currently taking prescription medication for concussion-related impairments, anticoagulants, antiplatelets, or medications for diabetes. If you're on these medications, you might not be eligible to participate.

What prior data suggests that the Clinical Assessment for Sports Exertion (CASE) is safe for athletes?

In previous studies, the Clinical Assessment for Sports Exertion (CASE) has helped athletes decide when it's safe to return to their sport. Research shows that this method can determine if an athlete is truly ready to play again. CASE includes exercises that mimic real sports activities to assess how an athlete's body responds, checking for signs like changes in heart rate or breathing.

Sports health experts designed CASE to understand how an athlete's body handles exertion, and its safety is well-regarded. No reports of serious negative effects or injuries from the test itself exist, suggesting that CASE is a safe way to assess if athletes are ready to play again. However, as with any physical activity, a small chance of discomfort or minor symptoms remains, which will be closely monitored during the assessment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it seeks to better understand how adolescents can safely return to sports after experiencing symptoms provoked by physical activity. Unlike current guidelines that may rely on subjective assessments, this study focuses on measuring physiological markers like blood pressure, heart rate, and oxygen saturation to provide a more objective evaluation. By doing so, it aims to identify personalized thresholds for safe exercise, potentially reducing the risk of symptoms worsening. This approach could lead to more effective and individualized recommendations, helping young athletes get back in the game safely and confidently.

What evidence suggests that the CASE is effective for assessing readiness to return to sport?

Research shows that the Clinical Assessment for Sports Exertion (CASE), which participants in this trial will undergo, helps athletes safely decide when to return to play. Studies have found that tests like CASE effectively check progress and determine if an athlete is ready to play again without risking further injury. This method evaluates physical performance by monitoring heart rate and symptoms during exercise. CASE is particularly helpful because it imitates real sports activities, identifying any remaining issues that might affect an athlete's performance. Overall, it aids in making informed decisions for a safe return to sports. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Asymptomatic at rest and must be cleared from return-to-play by a qualified healthcare professional no later than 30 days following clearance

You have been diagnosed with a concussion using the international concussion in sport group criteria.

10-22 years of age who have participated in organized sport activities within the past 12 months

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Assessment

Participants engage in sport-specific physical activities to assess physiological and symptomatic responses

1.5 hours

1 visit (in-person)

Follow-up

Participants are monitored for any changes in symptoms after physical activity

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CASE

Trial Overview 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.

How Is the Trial Designed?

Group I: CASE Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Sports Academy

Collaborator

Trials

2

Recruited

150+

Published Research Related to This Trial

A consensus was reached on a Physical Performance Assessment Checklist (PPAC) consisting of 12 critical constructs to evaluate an athlete's readiness to return to sport after a lower extremity injury, developed through a 3-round Delphi method with 9 expert participants.

The finalized PPAC serves as a valuable tool for guiding physical performance tests, ensuring that all necessary elements are considered for safe and effective return-to-sport decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a physical performance assessment checklist for athletes who sustained a lower extremity injury in preparation for return to sport: a delphi study. Haines, S., Baker, T., Donaldson, M.[2022]

Functional outcome data are crucial for ensuring safe and effective return to athletics for injured athletes, as they inform clinical decision-making and assess the efficacy of therapeutic interventions.

The paper provides guidelines for selecting or developing appropriate functional outcome measures, emphasizing the importance of considering patient population, pathology, test parameters, and practicality in both clinical practice and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcome measures for knee dysfunction assessment. Keskula, DR., Duncan, JB., Davis, VL., et al.[2022]

A study involving 4,903 adolescent athletes across 9 sports found that both male and female athletes reported high health levels on the Pediatric Quality of Life Inventory (PedsQL), with scores ranging from 82.6 to 95.7 for males and 83.9 to 95.2 for females.

The Multidimensional Fatigue Scale (MFS) indicated low levels of general and cognitive fatigue among athletes, with mean scores above 83.5 for males and 83.8 for females, suggesting that scores below these reference values may indicate poorer health and the need for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reference Values for the Pediatric Quality of Life Inventory and the Multidimensional Fatigue Scale in Adolescent Athletes by Sport and Sex. Snyder Valier, AR., Welch Bacon, CE., Bay, RC., et al.[2018]

The study developed specific assessment methods for evaluating the physical performance of athletes recovering from knee injuries, showing that these sport-specific tests are more effective than traditional diagnostic methods.

Using these tailored testing procedures alongside conventional diagnostics significantly reduced the frequency of repeated injuries in athletes, indicating a safer and more effective approach to rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The estimation of the effectiveness of early rehabilitation of the athletes practicing different sports after the knee injury with the use of specific simulators]. Preobrazhenskiĭ, VIu., Sidorenko, EV., Preobrazhenskiĭ, AV., et al.[2013]

Return to sport decisions after injury should be seen as a continuous process that aligns with recovery and rehabilitation, rather than a one-time decision at the end of treatment.

The consensus emphasizes the need for a standardized approach to defining and measuring return to sport outcomes, as current research evidence is limited, highlighting a gap in knowledge that future studies should address.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2016 Consensus statement on return to sport from the First World Congress in Sports Physical Therapy, Bern. Ardern, CL., Glasgow, P., Schneiders, A., et al.[2022]

The International Olympic Committee (IOC) has developed updated recommendations and a new STROBE extension for sports injury and illness studies to improve consistency in data collection and reporting, based on a comprehensive review involving international experts and a consensus meeting.

These guidelines aim to standardize definitions, classifications, and methodologies in sports injury research, which will help in tracking injury trends and developing protective measures for athletes' health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Olympic Committee consensus statement: methods for recording and reporting of epidemiological data on injury and illness in sport 2020 (including STROBE Extension for Sport Injury and Illness Surveillance (STROBE-SIIS)). Bahr, R., Clarsen, B., Derman, W., et al.[2023]

The updated football-specific consensus statement, developed by a panel of experts, aims to standardize methods for recording and reporting injuries and illnesses in football, ensuring consistency in future epidemiological studies.

By aligning with the International Olympic Committee's guidelines, this consensus will facilitate better comparisons across studies and improve data pooling, ultimately enhancing the understanding of football-related injuries and illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Football-specific extension of the IOC consensus statement: methods for recording and reporting of epidemiological data on injury and illness in sport 2020. Waldén, M., Mountjoy, M., McCall, A., et al.[2023]

The Sport Medicine Diagnostic Coding System (SMDCS) is a detailed classification system for sport-related injuries, developed in 1991, that allows for comprehensive data analysis based on body region, structure, and diagnosis.

Recent updates to the SMDCS align it with new consensus statements on injury data collection in sports like football and rugby, enhancing its utility for ongoing injury surveillance and prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Sport Medicine Diagnostic Coding System. Meeuwisse, WH., Wiley, JP.[2022]

The review emphasizes the need for a streamlined approach to clinical assessments by identifying a maximum of five key metrics that can effectively guide patient care and injury risk analyses, particularly for ACL injuries.

The five-factor maximum model can be applied to both the prevention of primary ACL injuries and the assessment of risk for secondary ACL injuries, suggesting a standardized method for evaluating injury risk across various contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Selection of Key Logistic Regression Variables for Risk Prediction Analyses: A Five-Factor Maximum Model. Hewett, TE., Webster, KE., Hurd, WJ.[2020]

The IOC's addendum provides a comprehensive framework specifically for recording and reporting health data in Para sports, addressing unique considerations for athletes with impairments, which were not fully covered in the original guidelines.

This new guidance aims to improve the understanding of injury and illness patterns in Para athletes, ultimately helping to develop targeted prevention programs and enhance medical service planning for Para sport events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Para sport translation of the IOC consensus on recording and reporting of data for injury and illness in sport. Derman, W., Badenhorst, M., Blauwet, C., et al.[2021]

In a study of 759 youth and young adult athletes, 14.6% failed the Gapski-Goodman Test (GGT) for return to play (RTP) clearance despite being asymptomatic, indicating that self-reported symptom status may not be sufficient for RTP decisions.

The GGT results were significantly influenced by initial symptom severity and pre-morbid anxiety, suggesting that these factors should be considered when determining an athlete's readiness to return to play after a concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of an intensive physical exertion test as a final return to play measure in concussed athletes: a prospective cohort. Marshall, CM., Chan, N., Tran, P., et al.[2019]

In a study involving 40 community-level Australian football teams, trained primary data collectors (PDCs) demonstrated a high level of reliability, achieving 98% agreement with independent observers on game details and 100% agreement on whether players left the field due to injury.

The PDCs showed strong agreement (79% for player counts and 76% for injury counts) with independent observers, indicating that exercise and sport science students can effectively collect accurate data in sports injury prevention research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Level of agreement between field-based data collectors in a large scale injury prevention randomised controlled trial. Twomey, DM., Finch, CF., Doyle, TL., et al.[2016]

Citations

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Physical Performance Assessment for Safe Return to Sport The available research shows that the Physical Performance Assessment for Safe Return to Sport is effective in helping athletes safely return to their sports ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3658404/

Functional Performance Testing for Power and Return to ... Functional performance testing (FPT) may objectively measure progress and determine rehabilitation effectiveness as well as whether the athlete is safe to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12056336/

A Guideline for Validated Return-to-Sport Testing ... To identify validated and feasible RTS tests that could reliably estimate the risk of reinjury after ACLR in everyday clinical practice.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X21002340

Physical Testing in Sports Rehabilitation: Implications on a ... This helps athletic trainers and medical personnel evaluate recovery and decide on a potential return to sport. A comprehensive holistic approach that includes ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/02640414.2025.2534224

A systematic review and network meta-analysis ABSTRACT. This study evaluated the relative effectiveness of using different return-to-sport (RTS) assessments to improve clinical decision-making following ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11252494/

Limited correlation between physical performance and ... This study sought to evaluate the associations between physical test performance in ACLr patients and known ACL injury risk factors, knee laxity and patient‐ ...

7. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/full/10.1002/jeo2.12071

Limited correlation between physical performance and patient ... This study sought to evaluate the associations between physical test performance in ACLr patients and known ACL injury risk factors, knee laxity and patient- ...