Chronic Effects of Tendon Vibrations on the Neuromechanical Muscular Properties.

Healthy Clinical Trial

— NEUROVIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668224
• Other study ID #: 1408208
• Secondary ID: 2015-A00036-43
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: August 25, 2016
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

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.

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.

Locations

Country	Name	City	State
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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of maximal voluntary strength in dorsal flexion of the ankle	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	No