Anterior Cruciate Ligament ReconstructionVIB_LCANCT02929004
Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction
A study testing Vibrasens in people with Anterior Cruciate Ligament Reconstruction, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
These last years, it has been proven that the solicitation of a muscle using vibration may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition of local vibration training sessions on the quadriceps muscle to the classic readaptation program (i.e. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Vibrasens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Dec 2016to 27 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Undergoing to surgery (i.e. ligamentoplasty) of the anterior cruciate ligament
Who cannot join
- Taking neuro-active substances which can lead to alteration of the corticospinal excitability
- Contra indications for using magnetic stimulation
- Participating in another study in the same time
Trial locations and contacts
2 sites in 1 country.
About this study
These last years, it has been proven that the solicitation of a muscle using vibration may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition of local vibration training sessions on the quadriceps muscle to the classic readaptation program (i.e. physiotherapist sessions) may allow a better recuperation 2 months after the surgery and the reconstruction of the anterior cruciate ligament.
The aim of the vibration training proposed in the current study is to allow a better recuperation 2 months after the anterior cruciate ligament reconstruction when compared with conventional physiotherapy alone.
- Being tested
- Vibrasens
- Keywords
- Anterior Cruciate Ligament Reconstruction, Local vibration training, Ligamentoplasty, Anterior cruciate ligament, Corticospinal excitability, Elastography, Knee extensor muscles, Readaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrasensDevice
Also called Vibrasens (TECHNO CONCEPT, France).
Transcutaneous vibrations are used. This device allows vibrations from 25 to 150 Hz with an amplitude of 1 mm. In our study the frequency used is 50 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Vibrasens | Experimental | In addition of classical physiotherapist sessions for the readaptation following anterior cruciate ligament reconstruction, this group will follow a local vibration training, using small and portable vibrator device.
Training programme: vibration training 3/week from Day 1 to Day 60 Receives: Device: Vibrasens |
| Usual activities | No intervention | Usual activities from day 1 to Day 60 during their classical physiotherapist sessions for the readaptation following anterior cruciate ligament reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary force
Maximal voluntary strength in dorsal flexion of the ankle
Measured: 60 days
Secondary outcomes (3)
6 minutes walking test
The patients will have to realize round trips by walking on a distance of 30 meters during 6 minutes. The total distance traveled by the patient will be calculated (in meters)
Measured: 60 days
Get up and Go test
The patient, sat on a seat placed in 3 meters of the wall, is invited:
- to get up
- to walk up to the wall
- to turn back
- to return up to their seat and
- to sit down there again The results will be expressed according to a highly-rated scale from 1 to 5
Measured: 60 days
The cortical level of activation (%)
It is determined by the increment of strength obtained further to a magnetic cortical stimulation realized during a condition of muscle in state of maximal contraction
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start16 Dec 2016
- Primary completion2 Feb 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal EDOUARD, MD, Principal investigator, CHU de SAINT-ETIENNEThomas LAPOLE, PhD, Study chair, Jean Monnet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929004
- Sponsor's protocol ID
- 1608114
- Other IDs
- 2016-A01358-43
- Acronym
- VIB_LCA
- Status last verified
- Dec 2022
- First submitted
- 7 Oct 2016
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coulondre C, Souron R, Rambaud A, Dalmais E, Espeit L, Neri T, Pinaroli A, Estour G, Millet GY, Rupp T, Feasson L, Edouard P, Lapole T. Local vibration training improves the recovery of quadriceps strength in early rehabilitation after anterior cruciate ligament reconstruction: A feasibility randomised controlled trial. Ann Phys Rehabil Med. 2022 Jun;65(4):101441. doi: 10.1016/j.rehab.2020.08.005. Epub 2021 Nov 13.
PubMed 33059096
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02929004
- Acronym / sponsor ID
- VIB_LCA / 1608114
- Keywords
- Anterior Cruciate Ligament Reconstruction, Local vibration training, Ligamentoplasty, Anterior cruciate ligament, Corticospinal excitability, Elastography, Knee extensor muscles, Readaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 10 Oct 2016 (estimated)
- 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.
These last years, it has been proven that the solicitation of a muscle using vibration may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition of local vibration training sessions on the quadriceps muscle to the classic readaptation program (i.e. physiotherapist sessions) may allow a better recuperation 2 months after the surgery and the reconstruction of the anterior cruciate ligament.
The aim of the vibration training proposed in the current study is to allow a better recuperation 2 months after the anterior cruciate ligament reconstruction when compared with conventional physiotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibrasens | Experimental | Device: VibrasensIn addition of classical physiotherapist sessions for the readaptation following anterior cruciate ligament reconstruction, this group will follow a local vibration training, using small and portable vibrator device. Training programme: vibration training 3/week from Day 1 to Day 60 |
| Usual activities | No intervention | –Usual activities from day 1 to Day 60 during their classical physiotherapist sessions for the readaptation following anterior cruciate ligament reconstruction. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Undergoing to surgery (i.e. ligamentoplasty) of the anterior cruciate ligament
Key exclusion criteria (3 listed)
- Taking neuro-active substances which can lead to alteration of the corticospinal excitability
- Contra indications for using magnetic stimulation
- Participating in another study in the same time
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 |
|---|---|---|
| VibrasensAlso: Vibrasens (TECHNO CONCEPT, France).Transcutaneous vibrations are used. This device allows vibrations from 25 to 150 Hz with an amplitude of 1 mm. In our study the frequency used is 50 Hz. | Device | Vibrasens |
Primary outcome
Maximal voluntary force
Time frame: 60 days
Maximal voluntary strength in dorsal flexion of the ankle
3 secondary outcomes
6 minutes walking test
Time frame: 60 days
Get up and Go test
Time frame: 60 days
The cortical level of activation (%)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Results publication: PubMed 33059096Coulondre C, Souron R, Rambaud A, Dalmais E, Espeit L, Neri T, Pinaroli A, Estour G, Millet GY, Rupp T, Feasson L, Edouard P, Lapole T. Local vibration training improves the recovery of quadriceps strength in early rehabilitation after anterior cruciate ligament reconstruction: A feasibility randomised controlled trial. Ann Phys Rehabil Med. 2022 Jun;65(4):101441. doi: 10.1016/j.rehab.2020.08.005. Epub 2021 Nov 13.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Reconstruction
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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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. This study is not recruiting at the moment.
Pascal EDOUARD, MD principal investigator
CHU de SAINT-ETIENNE
Thomas LAPOLE, PhD study chair
Jean Monnet University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrasens in people with Anterior Cruciate Ligament Reconstruction, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximal voluntary force (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02929004, which also lists 1 linked publication.
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 15 Dec 2022.