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Набор по приглашению NCT06827483

Adding Neurocognitive Component to Balance Test

— Наблюдательное Anterior Cruciate Ligament Injuries

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: Neurocognitive Component.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament Injuries. Базовые параметры: 18 лет — 25 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

Identifying Asymmetries in Reaction Time and Reach Distance by Adding a Neurocognitive Component to the Y-Balance Test of the Lower Quarter

Обзор

By introducing BlazePods as a neurocognitive addition to the YBT, this study aims to determine whether this addition impacts balance performance and/or reach distances between the operative and non-operative limbs of patients recovering from ACL reconstruction. Findings will contribute to optimizing return-to-sport protocols and enhancing late-stage rehabilitation program designs.

Подробное описание

The study team will measure performance under two conditions: the standard Y-Balance Test (YBT) and the YBT with an added neurocognitive component (YBT+NC). For the YBT+NC, the study team will attach Blaze Pods to the target area of the three reach indictors: anterior (A), posteromedial (PM), and posterolateral (PL). The Blaze Pods will light up in random sequences, requiring participants to slide the illuminated reach indicator as far as possible while maintaining balance on the stationary stance limb. Reaction time, individual reach distances (PM,PL,A), YBT composite score, and number of errors will be recorded and compared bilaterally.

To first establish feasibility and clinical utility, a pilot group of healthy participants will perform both the YBT and the YBT+NC with two simultaneous testers on two separate occasions separated by at least one day but no more than 28 days. The differences in reach distances, composite scores, and reaction times between the two test conditions will be compared. The study team will also determine intra- and inter-rater reliability as well as any learning effects.

For the patient cohort, the study team will employ a cross-sectional design to measure patients presenting for physical performance testing battery between 5-8 months post-anterior cruciate ligament reconstruction/repair (ACLR). This visit is standard of care for this population. If the patient is able to pass the initial screening test (maintain pain-free single leg balance for 10 seconds) a physical therapist will have the patient perform both the YBT and the YBT+NC as described above. The study team will compare the side-to-side differences between reaction time, reach distance, and number of errors (loss of balance) made.

Вмешательства

  • Другое Neurocognitive Component
    A neurocognitive component will be added to the Y Balance Test

Первичные конечные точки

  • Y-Balance Test - reach distance with and without neurocognitive component [Срок оценки: Day 1]
  • Y-Balance Test - composite score with and without neurocognitive component [Срок оценки: Day 1]
  • Reaction Time Asymmetry between limbs [Срок оценки: Day 1]
Вторичные конечные точки (4)
  • Reliability of Y-Balance Test - Inter-rater [Срок оценки: Day 8]
  • Reliability of Y-Balance Test - Intra-rater [Срок оценки: Day 8]
  • Reliability of Reaction Time Measurements - Inter-rater [Срок оценки: Day 8]
  • Reliability of Reaction Time Measurements - Intra-rater [Срок оценки: Day 8]

Критерии участия

Критерии включения

  • All participants: 18-25 years old
  • All participants: MARX activity questionnaire of greater than 10
  • All participants: able to follow verbal instructions
  • For patient participants: ACL Repair or Reconstruction within past 5-7 months

Критерии исключения

  • Healthy participants: Chronic Ankle Instability
  • Healthy participants: Prior lower extremity surgery
  • Healthy participants: LE injury <6 months ago
  • Healthy participants: current LE pain
  • Healthy participants: visual deficits
  • Healthy participants: vestibular or neurological deficits affecting balance
  • Healthy participants: unable to maintain single leg stance for 10 seconds
  • Healthy participants: unable to read or speak English
  • For patient participants: Chronic Ankle Instability
  • For patient participants: current LE pain
  • For patient participants: multi-ligament procedure
  • For patient participants: prior surgery on uninvolved limb
  • For patient participants: visual deficits
  • For patient participants: vestibular or neurological deficits affecting balance
  • For patient participants: unable to read or speak English
  • For patient participants: unable to maintain single leg stance for 10 seconds

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Duke Sports Science Institute — Durham

Идентификаторы

NCT: NCT06827483 · Pro00117009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗