NCT02668224

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 26, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

January 22, 2016

Last Update Submit

August 25, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Vibrasens : Test group

EXPERIMENTAL

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

Device: Vibrasens

Control group

ACTIVE COMPARATOR

Control: Usual activities from day 1 to Day 75.

Other: Usual activities

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.

Vibrasens : Test group
Usual activitiesOTHER

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

Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

Study Officials

  • Leonard FEASSON, MD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 29, 2016

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

August 26, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)