Chronic Effects of Tendon Vibrations on the Neuromechanical Muscular Properties. (NEUROVIB)

August 25, 2016 updated by: Centre Hospitalier Universitaire de Saint Etienne

Chronic Effects of Tendon Vibrations on the Neuromechanical Muscular Properties : Pilot Study, Interventional, Prospective, Longitudinal.

It is a randomized, controlled clinical trial, in healthy volunteers. They are in two groups : the test one will perform the vibration training (1h of Vibrasens 3 times a week, 24 sessions) whereas the control group will not be training. The primary outcome is the maximal voluntary strength.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

These last 10 years, a new idea born: vibrations could have potential effects on muscular reconditioning. Researchers have previously demonstrated the effects on plantar ankle flexion, with the increase of the strength, on healthy volunteers. Nowadays physicians would like to demonstrate the effects on another muscular group: ankle's dorsal flexors. 24 sessions are programmed on 8 weeks.

Moreover, the last results showed a modification of the nervous capacities of the cortical voluntary activation. Transcranial Magnetic Stimulation (TMS) is a great tool to explore the neuromuscular function, at the cortical stage. The use of this tool will allow the characterization the effects of the vibration training on the cortical activation state.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18 and 50 years old
  • Both gender
  • Occasional sportsman (<4h/week)
  • Affiliated to a social security scheme
  • Having freely given their written consent

Exclusion Criteria:

  • Taking neuro-active substances able to modify cortico-spinal excitability from Day 10 to the end of the study
  • Contraindication to magnetic field application
  • Previous pathologies susceptible to modify the process of the tests (particularly stakeholders presenting knee or ankle pathologies)
  • Participation during the same time in another interventional experimentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibrasens : Test group
Training programme: vibration training 3/week from Day 1 to Day 60 + Usual activities from day 60 to Day 75.
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.
Active Comparator: Control group
Control: Usual activities from day 1 to Day 75.
Other: Usual activities
The patients will perform their usual activities, to allow the comparison with a vibration programme. They will not have a specific training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of maximal voluntary strength in dorsal flexion of the ankle
Time Frame: 8 weeks
Determine if a training of 24 sessions of tendon vibrations of dorsal flexors' ankles programmed on 8 weeks allows the increase of the maximal voluntary strength in ankles' dorsal flexion, compared to a control group, with no vibration.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1408208
  • 2015-A00036-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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