The Impact of Superimposed Vibration on the Recovery of Muscle Strength and Function Following Anterior Cruciate Ligament Surgery (VIBRA-LCA)

April 21, 2026 updated by: Centre orthopédique de Dracy-le-Fort
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Traditional rehabilitation without vibration
Other: No device
No device applied on quadriceps
Experimental: Application of localized vibration during certain muscle-strengthening exercises
The stimulation is delivered at 100 Hz with an amplitude of 2-3 mm, parameters that allow for optimal activation of Ia afferents (Eklund et al., 1966). Contact is provided by a 5 cm × 1 cm skin interface positioned on the muscular body of the quadriceps of each thigh.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Quadriceps Strength Recovery During Postoperative Rehabilitation Following Anterior Cruciate Ligament Reconstruction, With or Without Local Vibration Superimposed on Muscle Strengthening Exercises
Time Frame: 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.
Before surgery and after 6 weeks of rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre orthopédique de Dracy-le-Fort

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-52-DLF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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