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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Physical Performance Assessment for Safe Return to Sport is an effective treatment?

The available research shows that the Physical Performance Assessment for Safe Return to Sport is effective in helping athletes safely return to their sports after an injury. The study on functional outcome measures highlights the importance of using data to make informed decisions about an athlete's readiness to return, ensuring a safe and efficient process. Additionally, the research on the use of an intensive physical exertion test for concussed athletes supports the idea that specific assessments can be valuable in determining when an athlete is ready to return to play. These studies suggest that using structured assessments can improve the decision-making process for returning athletes to their sports safely. ^{1 2 3 4 5}

What safety data exists for the Physical Performance Assessment for Safe Return to Sport treatment?

The provided research does not directly address safety data for the Physical Performance Assessment for Safe Return to Sport or its alternative name, CASE. The studies focus on data collection methods, injury and illness surveillance, and consensus statements for sports injury reporting. None of the abstracts specifically mention safety data related to the treatment in question. ^{6 7 8 9 10}

Is the treatment in the trial 'Physical Performance Assessment for Safe Return to Sport' a promising treatment?

Yes, the treatment is promising because it focuses on creating a checklist to help athletes safely return to sports after an injury. This approach aims to ensure athletes are ready to play again by assessing their physical performance, which can reduce the risk of getting hurt again. ^{1 3 4 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Systematic Selection of Key Logistic Regression Variables for Risk Prediction Analyses: A Five-Factor Maximum Model. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Functional outcome measures for knee dysfunction assessment. [2022]

3. United States 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. [2022]

4. England 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. [2019]

5. United States 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. [2018]

6. England 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)). [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Level of agreement between field-based data collectors in a large scale injury prevention randomised controlled trial. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Para sport translation of the IOC consensus on recording and reporting of data for injury and illness in sport. [2021]

9. England 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The Sport Medicine Diagnostic Coding System. [2022]

11. England pubmed.ncbi.nlm.nih.gov

2016 Consensus statement on return to sport from the First World Congress in Sports Physical Therapy, Bern. [2022]

12. Russia (Federation) 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]. [2013]