Anterior Cruciate Ligament ReconstructionVIBRA-LCANCT07555613
The Impact of Superimposed Vibration on the Recovery of Muscle Strength and Function Following Anterior Cruciate Ligament Surgery
A study testing Vibramoov, Techno Concept, Mane, France and No device in people with Anterior Cruciate Ligament Reconstruction, run by Centre orthopédique de Dracy-le-Fort.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Vibramoov, Techno Concept, Mane, France and No device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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.
Read the 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.
- Being tested
- Vibramoov, Techno Concept, Mane, France, No device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibramoov, Techno Concept, Mane, FranceDevice
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.
No deviceOther
No device applied on quadriceps
| Study group | Role | What they receive |
|---|---|---|
| Traditional rehabilitation without vibration | Sham comparator | Not described Receives: 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. Receives: Device: Vibramoov, Techno Concept, Mane, France |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery and after 6 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Aug 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre orthopédique de Dracy-le-Fort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555613
- Sponsor's protocol ID
- 2025-52-DLF
- Acronym
- VIBRA-LCA
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Superimposed Vibration on the Recovery of Muscle Strength and Function Following Anterior Cruciate Ligament Surgery
- ClinicalTrials.gov ID
- NCT07555613
- Acronym / sponsor ID
- VIBRA-LCA / 2025-52-DLF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Centre orthopédique de Dracy-le-FortUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional rehabilitation without vibration | Sham comparator | Other: No device |
| Application of localized vibration during certain muscle-strengthening exercises | Experimental | Device: Vibramoov, Techno Concept, Mane, FranceThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibramoov, Techno Concept, Mane, FranceLocal 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. | Device | Application of localized vibration during certain muscle-strengthening exercises |
| No deviceNo device applied on quadriceps | Other | Traditional rehabilitation without vibration |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vibramoov, Techno Concept, Mane, France and No device in people with Anterior Cruciate Ligament Reconstruction, run by Centre orthopédique de Dracy-le-Fort.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.