The Impact of Superimposed Vibration on the Recovery of Muscle Strength and Function Following Anterior Cruciate Ligament Surgery

Обзор

Restoring muscle strength following knee ligament reconstruction (of the anterior cruciate ligament, ACL) is a major challenge for the functional success of rehabilitation. Despite advances in rehabilitation protocols, many patients still experience persistent strength deficits several months after surgery. Current rehabilitation strategies rely primarily on neuromuscular training programs aimed at restoring maximum strength and joint range of motion. However, these approaches exhibit significant interindividual variability and do not always fully resolve persistent muscle inhibition. In this context, local vibration appears to be a promising tool. This project aims to evaluate the benefits of repeated application of local vibration superimposed on muscle strengthening exercises (recovery of quadriceps strength, single-leg balance, quadriceps power, perception of effort and pain, knee range of motion) performed during the first six weeks of post-ligamentoplasty rehabilitation. The underlying hypothesis is that the addition of sensory stimulation via vibration, superimposed on rehabilitation exercises, could facilitate muscle activation and, ultimately, accelerate the functional recovery of the quadriceps.The expected results could help validate the use of this approach as a standardized tool within post-ACL rehabilitation protocols, by promoting faster muscle recovery and reducing the duration of functional disability.

Подробное описание

The primary objective of this single-center, prospective, open-label, randomized, controlled, two-arm interventional study is to evaluate the effect of local vibration applied during muscle strengthening exercises on quadriceps strength recovery during postoperative rehabilitation following anterior cruciate ligament reconstruction.

The secondary objectives of this study are to evaluate the effect of applying vibration superimposed on muscle contraction on single-leg balance, quadriceps power, perceived exertion and pain, as well as on knee range of motion and muscle symmetry during the 6 weeks of postoperative rehabilitation.

Вмешательства

• Устройство Vibramoov, Techno Concept, Mane, France
  Local vibration superimposed on muscle contraction (SLV) is delivered using a dedicated device (Vibramoov, Techno Concept, Mane, France), which bears the CE mark (European Medical Devices Directive, Class IIa) and is designed and manufactured in accordance with ISO 13485: 2016.
• Другое No device
  No device applied on quadriceps

Первичные конечные точки

• Assessment of Quadriceps Strength Recovery During Postoperative Rehabilitation Following Anterior Cruciate Ligament Reconstruction, With or Without Local Vibration Superimposed on Muscle Strengthening Exercises [Срок оценки: Before surgery and after 6 weeks of rehabilitation]

Критерии участия

Критерии включения

• Men or women who have undergone anterior cruciate ligament reconstruction (using the Kenneth Jones method or a hamstring graft) on the right or left leg
• Be between the ages of 18 and 45
• Be enrolled in or eligible for a social security program
• Have signed an informed consent form

Критерии исключения

• Patients who have previously undergone anterior cruciate ligament reconstruction
• Patients not currently under care at the Dracy-le-Fort Orthopedic Center
• Patients with chronic sensorimotor disorders
• Patients who have previously undergone ligament reconstruction on the knee currently being operated on
• Patients undergoing surgery more than one year after a cruciate ligament rupture
• Pregnant women, women in labor, or breastfeeding women
• Individuals subject to legal protection measures (judicial protection, guardianship, or conservatorship)
• Individuals deprived of liberty by judicial or administrative order
• Individuals receiving psychiatric care
• Individuals subject to a period of exclusion for another study
• Non-consenting subjects who cannot give consent, or cannot return for scheduled visits as per the protocol

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07555613 · 2025-52-DLF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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