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Набор скоро начнётся NCT06783062

Activation Failure of Knee Extensors After Anterior Cruciate Ligament Rupture Depending on the Contraction Mode

Наблюдательное ACL - Anterior Cruciate Ligament Rupture Activation Failure Contraction Mode

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: ACL - Anterior Cruciate Ligament Rupture, Activation Failure, Contraction Mode. Базовые параметры: 18 лет — 50 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The primary objective of the study is to evaluate the impact of ACL injury and ACL reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode. The goal is to provide elements of knowledge to clinicians about the mechanisms of the activation failure depending on contraction mode, but also the resulting adapted clinical recommendations for conducting rehabilitation, and particularly for the use of different contraction modes. The main hypothesis is that activation failure is not equal according to the contraction mode during maximal voluntary contractions and neurophysiological parameters will be decreased in comparison with non-injured subjects. Secondary objectives are: * To analyze the evolution of neurophysiological parameters between sessions interspaced by several months according to the contraction mode. * To observe this time evolution depending on the treatment strategy chosen: rehabilitation or surgery plus rehabilitation.

Первичные конечные точки

  • Voluntary Activation Level [Срок оценки: Between 2 and 6 weeks after ACL rupture]
Вторичные конечные точки (5)
  • Maximal voluntary torque [Срок оценки: between 2 to 6 weeks after ACL rupture]
  • EMG activity of vastus lateralis, vastus medialis and rectus femoris [Срок оценки: between 2 to 6 weeks after ACL rupture]
  • Voluntary Activation Level [Срок оценки: Around 9 months after ACL rupture]
  • Maximal voluntary torque [Срок оценки: Around 9 months after ACL rupture]
  • EMG activity of vastus lateralis, vastus medialis and rectus femoris [Срок оценки: Around 9 months after ACL rupture]

Критерии участия

Критерии включения

A. ACL-injured groups (surgically or conservatively treated):

  • Age between 18 and 50 years
  • Free, informed consent signed by the participant and the investigator.
  • Session 1: Delay of 2 to 6 weeks after injury, with a quiet knee (range of motion 110- 0°, minimal effusion, maximal contraction pain ≤ 2/10)
  • Session 2: Duration of 36 to 42 weeks after injury, with a quiet knee (range of motion 110-0°, minimal effusion, maximal contraction pain ≤ 2/10)
  • Independent person (Unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision)

B. ControlGroup:

  • Age between 18 and 50 years
  • Free, informed consent signed by the participant and the investigator.
  • Sport practitioners: at least once per week practicing activities like collective sports, racket sports, combat sports, skiing, or on-loading activities with changing of directions.
  • Independent person (Unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision)

Критерии исключения

  • 1\. Subjects fitted with an implanted electronic device such as a cardiac pacemaker 2. Professional athlete 3. Pregnant women 4. Subject with systemic pathology or treatment affecting the musculoskeletal system 5. Subject with a history of neurological pathology or traumatic pathology, or pathology that required orthopedic treatment and/or surgery of the knee, hip and/or lumbar spine 6. Contraindication to isokinetic testing: incapacitating pain, evolving pathological process, non- healed fracture, unbalanced cardiovascular pathology (angina pectoris, arterial hypertension) 7. Contralateral knee injury 8. Subject inability to follow procedures or insufficient knowledge of project language 9. Data acquisition issue or injury during testing

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06783062 · 2024-01580

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗