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Completed

NCT Number: NCT02929004

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEPART, Challes-les-Eaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrasens

Device

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.

Other names: Vibrasens (TECHNO CONCEPT, France).

Primary outcomes

  1. Maximal voluntary force

    Time frame: 60 days

    Maximal voluntary strength in dorsal flexion of the ankle

Secondary outcomes

  1. 6 minutes walking test

    Time frame: 60 days

    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)

  2. Get up and Go test

    Time frame: 60 days

    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

  3. The cortical level of activation (%)

    Time frame: 60 days

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: VIB_LCA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2016
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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