NCT07555613

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Apr 2026

Status
not yet recruiting

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 Progress6%
Apr 2026Dec 2027

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 15, 2026

Last Update Submit

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 COMPARATOR
Other: No device

Application of localized vibration during certain muscle-strengthening exercises

EXPERIMENTAL

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

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.

Application of localized vibration during certain muscle-strengthening exercises

No device applied on quadriceps

Traditional rehabilitation without vibration

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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