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

NCT ID: NCT02929004

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-16

Study Completion Date

2020-04-27

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Reconstruction

Keywords

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Anterior Cruciate Ligament Reconstruction Local vibration training Ligamentoplasty Anterior cruciate ligament Corticospinal excitability Elastography Knee extensor muscles Readaptation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vibrasens

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

Group Type EXPERIMENTAL

Vibrasens

Intervention Type 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.

Usual activities

Usual activities from day 1 to Day 60 during their classical physiotherapist sessions for the readaptation following anterior cruciate ligament reconstruction.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Vibrasens (TECHNO CONCEPT, France).

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal EDOUARD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Thomas LAPOLE, PhD

Role: STUDY_CHAIR

Jean Monnet University

Locations

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CEPART

Challes-les-Eaux, , France

Site Status

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 33059096 (View on PubMed)

Other Identifiers

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2016-A01358-43

Identifier Type: OTHER

Identifier Source: secondary_id

1608114

Identifier Type: -

Identifier Source: org_study_id