Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Reconstruction Clinical Trial

— VIB_LCA  

Official title:

Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929004
• Other study ID #: 1608114
• Secondary ID: 2016-A01358-43
• Status: Completed
• Phase: N/A
• Start date: December 16, 2016
• Est. completion date: April 27, 2020

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 27, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Undergoing to surgery (i.e. ligamentoplasty) of the anterior cruciate ligament

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Device:
• Vibrasens
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.

Locations

Country	Name	City	State
France	CEPART	Challes-les-Eaux
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

References & Publications (1)

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 l — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal voluntary force	Maximal voluntary strength in dorsal flexion of the ankle	60 days
Secondary	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)	60 days
Secondary	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	60 days
Secondary	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	60 days