NCT02929004

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 16, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

3.1 years

First QC Date

October 7, 2016

Last Update Submit

December 13, 2022

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Anterior Cruciate Ligament ReconstructionLocal vibration trainingLigamentoplastyAnterior cruciate ligamentCorticospinal excitabilityElastographyKnee extensor musclesReadaptation

Outcome Measures

Primary Outcomes (1)

  • Maximal voluntary force

    Maximal voluntary strength in dorsal flexion of the ankle

    60 days

Secondary Outcomes (3)

  • 6 minutes walking test

    60 days

  • Get up and Go test

    60 days

  • The cortical level of activation (%)

    60 days

Study Arms (2)

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

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.

Interventions

VibrasensDEVICE

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.

Also known as: Vibrasens (TECHNO CONCEPT, France).
Vibrasens

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CEPART

Challes-les-Eaux, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

Related 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 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.

    PMID: 33059096RESULT

Study Officials

  • Pascal EDOUARD, MD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

  • Thomas LAPOLE, PhD

    Jean Monnet University

    STUDY CHAIR

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

October 7, 2016

First Posted

October 10, 2016

Study Start

December 16, 2016

Primary Completion

February 2, 2020

Study Completion

April 27, 2020

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)