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Набор по приглашению NCT05942638

Longitudinal Assessment of Post-concussion Driving in Young Adults

— Наблюдательное Brain Injuries, Traumatic Concussion, Brain Brain Injury Traumatic Mild

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Brain Injuries, Traumatic, Concussion, Brain, Brain Injury Traumatic Mild. Базовые параметры: от 18 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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Обзор

Upwards of 3.8 million concussions occur annually in the United States. Driving is a highly complicated activity that requires visual, motor, and cognitive skills, which are commonly impaired after concussion. Yet, the time course of post-concussion driving impairment has not been characterized. There is a critical need to 1) determine when concussed individuals should return to driving and 2) identify the key concussion assessment predictors of readiness to return to driving. In the absence of formal recommendations, impaired concussed drivers are at risk to themselves and others on the road. The first specific aim is to compare simulated driving between concussed individuals and non-concussed yoked matched controls across five longitudinal timepoints (pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance) and daily naturalistic driving from day 2 to day 9. Driving recommendations must be appropriate and necessitated by concussion impairments, since excessively strict recommendations wrongfully strip concussed patients of their independence and may dissuade individuals from seeking medical care. The second specific aim is to identify widely used concussion assessment outcomes that predict simulated driving performance among concussed individuals throughout concussion recovery. To address these aims, 100 concussed and 100 yoked matched control young adult college athletes will complete a simulated driving assessment and a robust concussion assessment battery at pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance. Naturalistic driving (measured with in-car global positioning systems) will be captured from day 2 to day 9 (7 days total). This study will determine the acute and subacute time course of post-concussion driving impairment and determine key predictors of post-concussion driving performance. Results from this innovative approach will have a broad and positive impact that will improve the safety of both concussed individuals and the general population, guide the practices of health professionals, inform the future work of researchers, and substantiate the work of policy-makers by providing evidence-based recommendations for managing post-concussion driving.

Первичные конечные точки

  • Centerline Crossings (count) [Срок оценки: Pre-injury baseline]
  • Centerline Crossings (count) [Срок оценки: Day 2]
  • Centerline Crossings (count) [Срок оценки: Day 4]
  • Centerline Crossings (count) [Срок оценки: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)]
  • Centerline Crossings (count) [Срок оценки: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)]
  • Road edge excursions (count) [Срок оценки: Pre-injury baseline]
  • Road edge excursions (count) [Срок оценки: Day 2]
  • Road edge excursions (count) [Срок оценки: Day 4]
  • Road edge excursions (count) [Срок оценки: Within 24 hours of when symptoms resolve (Asymptomatic) (on average <30 days post-concussion - tracked up to 1 year)]
  • Road edge excursions (count) [Срок оценки: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)]
Вторичные конечные точки (12)
  • Pedestrian Collisions (count) [Срок оценки: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
  • Speed exceedances (count) [Срок оценки: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
  • Percent time over speed limit (%) [Срок оценки: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
  • Percent time out of lane (%) [Срок оценки: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
  • Lateral lane position (feet) [Срок оценки: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
  • Speed (miles per hour) [Срок оценки: Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
  • Number of speeding events (count) [Срок оценки: Up to 9 days post-injury]
  • Hard braking events (count) [Срок оценки: Up to 9 days post-injury]
  • Hard acceleration events (count) [Срок оценки: Up to 9 days post-injury]
  • Hard cornering events (count) [Срок оценки: Up to 9 days post-injury]
  • UFOV Processing Speed (ms) [Срок оценки: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]
  • UFOV Divided Attention (ms) [Срок оценки: Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance]

Критерии участия

Критерии включения

  • 18 years old or older
  • Possesses a valid driver's license
  • 1 year or more of driving experience
  • Normal or corrected-to-normal vision
  • Rostered on an organized athletic team at the college level
  • (Concussion Group Only) Diagnosed with concussion by a physician and meet inclusion criteria above.

Критерии исключения

  • Four or more previous concussions
  • A concussion within the past 6 months
  • History of any major neurological disorders or injuries
  • Current use of any medications that evoke drowsiness (prescription or over the counter)
  • Current orthopedic condition that interferes with driving (e.g. a walking boot, shoulder immobilizer)
  • Heavy use of alcohol (binge drinking 5+ days in the past 30 days)
  • Any illegal drug use (any illegal substance use)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Ramsey Student Center — Athens

Идентификаторы

NCT: NCT05942638 · PROJECT00007249

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗