The Impact of Superimposed Vibration on the Recovery of Muscle Strength and Function Following Anterior Cruciate Ligament Surgery
VIBRA-LCA
1 other identifier
interventional
62
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 15, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 29, 2026
April 1, 2026
1.5 years
April 15, 2026
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of Quadriceps Strength Recovery During Postoperative Rehabilitation Following Anterior Cruciate Ligament Reconstruction, With or Without Local Vibration Superimposed on Muscle Strengthening Exercises
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
Study Arms (2)
Traditional rehabilitation without vibration
SHAM COMPARATORApplication of localized vibration during certain muscle-strengthening exercises
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Non-consenting subjects who cannot give consent, or cannot return for scheduled visits as per the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2026
First Posted
April 29, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04