Chronic Effects of Tendon Vibrations on the Neuromechanical Muscular Properties.

NCT ID: NCT02668224

Last Updated: 2016-08-26

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Vibrasens : Test group

Training programme: vibration training 3/week from Day 1 to Day 60 + Usual activities from day 60 to Day 75.

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.

Control group

Control: Usual activities from day 1 to Day 75.

Group Type ACTIVE_COMPARATOR

Usual activities

Intervention Type OTHER

The patients will perform their usual activities, to allow the comparison with a vibration programme. They will not have a specific training.

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

Usual activities

The patients will perform their usual activities, to allow the comparison with a vibration programme. They will not have a specific training.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Leonard FEASSON, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00036-43

Identifier Type: OTHER

Identifier Source: secondary_id

1408208

Identifier Type: -

Identifier Source: org_study_id

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