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Идёт набор NCT07411625

Preoperative Rehabilitation for Patient With an ACL Injury

Без фазы С лечением Anterior Cruciate Ligament (ACL)

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: Resistance training, Traditional exercises.
Кому может быть актуально
Состояния в реестре: Anterior Cruciate Ligament (ACL). 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
Франция
Следующий шаг
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Официальное название

Comparison of Two Programs Delivered During Rehabilitation Before an Anteriror Cruciate Ligament Reconstruction : a Randomised Controlled Trial K-POP

Обзор

Muscle qualities are critical for the recovery after an anterior cruciate ligament (ACL) injury. Before ACL reconstruction (ALCR), resistance training aims to maintain patient strength and volume in order to optimize recovery. Unanswered questions remain on the modalities of resistance training before ACLR. This protocol details a pragmatic clinical trial that primary aims to increase the maximal strength of knee extensors and flexors and to induce hypertrophy before ACLR. Participants awaiting ACLR will be recruited from outpatient rehabilitation clinics and will be randomly allocated to one group to attend a 9-weeks rehabilitation program before ACLR. Participants of 'resistance training' group will perform a training program built on the principles of strength training to increase knee muscles strength and volume. Three blocks of 3 weeks will induce a progressive increase in training load, with exercises performed close to failure. Participants of 'usual group' will perform traditional exercises including: balance/proprioceptive exercises, weight-balances exercises, and body-weight resistance training exercises. Groups will be compared on muscle strength (primary outcome), clinical outcomes (muscle volume, stiffness, knee mobility, effusion) and self-reported outcomes (quality of life, perception of knee function, pain, anxiety and depression, exertion, health consumption, participations in activities) before and after ACLR. Outcomes will be collected by a blinded assessor before and after the resistance training program (before ACLR); 4 and 9 months after the ACLR.

Вмешательства

  • Другое Resistance training
    Participants of 'resistance training' group will perform a training program built on the principles of strength training to increase knee muscles strength and volume. Three blocks of 3 weeks will induce a progressive increase in training load, with exercises performed close to failure. The exercising part for participants of 'RT group' will be composed by a progressive increase in load over the 9 weeks. For that purpose, the intensity of load will be increased each 3 weeks (i.e. on the session 1
  • Другое Traditional exercises
    Participants of 'usual group' will perform traditional exercises including: balance/proprioceptive exercises, weight-balances exercises, and body-weight resistance training exercises. The exercising part for participants of 'usual training group' will comport traditional exercises used in prehabilitation, including: balance/proprioceptive exercises, weight-balances exercises, and body-weight resistance training exercises. Again, the 9 weeks will be sub-divided into 3 blocks of 3 weeks for induc

Первичные конечные точки

  • Maximal torque for knee extension in isometric condition [Срок оценки: In the week following the 9 weeks of preoperative rehabilitation]
Вторичные конечные точки (6)
  • Knee extension and flexion torque [Срок оценки: First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)]
  • Voluntary activation [Срок оценки: First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)]
  • Change in muscle volume [Срок оценки: First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)]
  • KOOS questionnaire [Срок оценки: First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)]
  • SANE scale. [Срок оценки: First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)]
  • HAD scale [Срок оценки: First visit, (T0), visit at 9 weeks of preoperative rehabilitation (T1), visit 4 months after surgery (T2), visit 9 months after surgery (T3)]

Критерии участия

Критерии включения

  • Being over 18 years
  • A first episode of an ACL injury
  • An ACLR scheduled at least 10 weeks later, with a surgical technique using hamstring, gracilis, or quadriceps/patellar tendon autograft
  • A minimum passive range of motion of the knee between 10° of extension deficit, and 80° of flexion
  • A medical prescription for prehabilitation
  • Possibility to attend prehabilitation program and post-ACLR rehabilitation in one of the 15 clinics

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • University Hospital - Laboratoire "Motricité, Interactions, Performance" (UR 4334) — Nantes

Идентификаторы

NCT: NCT07411625 · RC25_0050

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗