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Набор по приглашению NCT05013307

Clinical Assessment of Sports Exertion

Без фазы С лечением Return to Sport

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CASE.
Кому может быть актуально
Состояния в реестре: Return to Sport. Базовые параметры: 10 лет — 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Heart rate (bpm) [Срок оценки: through study completion, an average of 1.5 hours]
  • Blood pressure (mmHg) [Срок оценки: through study completion, an average of 1.5 hours]
  • Oxygen Saturation (%) [Срок оценки: through study completion, an average of 1.5 hours]
  • Rate of Perceived Exertion (Borg 6-20) [Срок оценки: through study completion, an average of 1.5 hours]
  • Self-rated lightheadedness (0-6) [Срок оценки: through study completion, an average of 1.5 hours]
  • Self-rated dyspnea (Modified Borg 0-10) [Срок оценки: through study completion, an average of 1.5 hours]
  • Heart rate reserve (peak-rest), beats/min-1 [Срок оценки: through study completion, an average of 1.5 hours]
Вторичные конечные точки (1)
  • Modified Post-Concussion Symptom Scale (PCSS) (0-6) [Срок оценки: through study completion, an average of 1.5 hours]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • Baylor Scott and White Sports Therapy and Research — Frisco

Идентификаторы

NCT: NCT05013307 · 021-143

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗