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Набор скоро начнётся NCT07389850

Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery

Без фазы С лечением Anterior Cruciate Ligament Rupture With Ligamentoplasty

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: ReproEVO intervention.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament Rupture With Ligamentoplasty. Базовые параметры: 15 лет — 40 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
Франция
Следующий шаг
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Официальное название

Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery - ReproEVO

Обзор

Anterior cruciate ligament (ACL) injury is the most common knee injury among athletes who play contact sports involving pivoting. ACL reconstruction (ACLR) combined with rehabilitation is the standard treatment for ACL tears in athletes, and rehabilitation is one of the keys to success. The overall return to sport rate is 80%, but the return to pre-injury level of sport is only 65% and the return to the same level of competition is only 55%. The recurrence rate is close to 20%. During rehabilitation and sports practice, proprioceptive information is essential for adjusting the muscle sensorimotor loop and enabling optimal movement. Athletes can thus be classified as plastic or rigid . Our hypothesis is to show that the proportion of "plastic" patients 9 months post-operative following ACL reconstruction is higher than that found in the same population 3 months post-operative, thus demonstrating the progression of proprioceptive integration abilities after ACL reconstruction surgery.

Подробное описание

Anterior cruciate ligament (ACL) injury is the most common knee injury among athletes who play contact sports involving pivoting. ACL reconstruction (ACLR) combined with rehabilitation is the standard treatment for ACL tears in athletes, and rehabilitation is one of the keys to success. The overall return to sport rate is 80%, but the return to pre-injury level of sport is only 65% and the return to the same level of competition is only 55%. The recurrence rate is close to 20%. Although the number of studies on the subject is growing, there is currently no consensus on rehabilitation protocols.

During rehabilitation and sports practice, proprioceptive information is essential for adjusting the muscle sensorimotor loop and enabling optimal movement.

We have demonstrated that athletes and athletes after ACL reconstruction show variability in the integration of proprioceptive information during a complex balance task.

Athletes can thus be classified as plastic (able to vary the source of proprioceptive information depending on conditions) or rigid (unable to do so).

Our hypothesis is to show that the proportion of "plastic" patients 9 months post-operative following ACL reconstruction is higher than that found in the same population 3 months post-operative, thus demonstrating the progression of proprioceptive integration abilities after ACL reconstruction surgery.

Вмешательства

  • Процедура ReproEVO intervention
    After the inclusion visit, each assessment will include an examination of standing balance in two support conditions: hard floor or soft floor and two conditions of vibration of the Achilles tendons or lumbar muscles, performed randomly over five trials for each condition. The subjects stand with their eyes covered by an opaque mask. Vibrators are positioned at both locations and vibrated randomly after a trial without recording to perceive the destabilizing effect induced by the vibration. The

Первичные конечные точки

  • Assessment of progress in proprioceptive reweighting after knee ligament reconstruction [Срок оценки: Baseline, 3 months after surgery and 9 months after surgery]
Вторичные конечные точки (4)
  • Assesment of the variation in weighting between before and after the operation [Срок оценки: Baseline and 3 months postoperatively]
  • Assess postural control [Срок оценки: Baseline, at 3 months postoperatively and at 9 months postoperatively]
  • Assess your Anterior Cruciate Ligament - Return to Sport and Injury (ACL-RSI) perception score [Срок оценки: Baseline, at 3 months postoperatively and at 9 months postoperatively]
  • Assess the subjective IKDC activity score [Срок оценки: Baseline, at 3 months postoperatively and at 9 months postoperatively]

Критерии участия

Критерии включения

  • Aged between 15 and 40;
  • Patients with ACL rupture scheduled for ACL reconstruction surgery;
  • Patients able to maintain a stable bipedal standing position without technical assistance and with their eyes closed;
  • Consent of the patient, parents, legal guardians, or guardians to the recording (for minor patients) of data for research and publication purposes.

Критерии исключения

  • Recent osteoarticular pathology (i.e., less than three months) of the lower limbs, whether traumatic or not, other than ACL rupture;
  • Proven disabling neurological pathology;
  • Pain in the musculoskeletal system during exercise (excluding the operated knee);
  • Fatigue assessed using the Borg scale > 6;
  • Skin allergy to an adhesive product.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 3 центра
  • Brest University Hospital — Brest
  • Montpellier University Hospital — Montpellier
  • Dr. STER Clinic, Saint Clément de Rivière — Saint-Clément-de-Rivière

Идентификаторы

NCT: NCT07389850 · 29BRC25.0312

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗