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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00036-43 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibrasens : Test group | Experimental | Training programme: vibration training 3/week from Day 1 to Day 60 + Usual activities from day 60 to Day 75. |
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| Control group | Active Comparator | Control: Usual activities from day 1 to Day 75. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrasens | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard FEASSON, MD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de SAINT-ETIENNE | Saint-Etienne | 42000 | France |
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| Usual activities | Other | The patients will perform their usual activities, to allow the comparison with a vibration programme. They will not have a specific training. |
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