Anterior Cruciate Ligament Reconstruction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVibramoov, 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.
OTHERNo device
No device applied on quadriceps
Sponsors
Centre orthopédique de Dracy-le-Fort
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Quadriceps Strength Recovery During Postoperative Rehabilitation Following Anterior Cruciate Ligament Reconstruction, With or Without Local Vibration Superimposed on Muscle Strengthening Exercises | Before surgery and after 6 weeks of rehabilitation | Measurement of changes in strength, with or without vibrations applied to the quadriceps during rehabilitation sessions. Quadriceps strenght will be measured by the maximum voluntary isometric contraction (MVIC): maximum force (kg) while seated. A quadriceps warm-up will begin with progressive isometric contractions, consisting of ten knee-extension contractions of the injured leg, ranging from light to strong intensity depending on the patient's perception. Following this, the patient will perform two 5-second maximal voluntary isometric contractions (MVICs) in extension, separated by 1-minute recovery periods, to measure quadriceps strength. |
Outcome results
None listed