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Recruiting NCT07344298

Less is Better? Effectiveness of a Short Local Vibration Protocol on Neuromuscular Function

No phase Interventional Healthy Volonteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local vibration protocol.
Who it may be relevant to
Registry conditions: Healthy Volonteers. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Local vibration is a non-invasive neuromuscular stimulation modality used in training and rehabilitation for its effects on neuromuscular function, particularly its ability to induce nervous adaptations. Its passive application is particularly useful in cases of motor deficit or immobilization. Several studies, including our own, have shown that vibration protocols over several weeks can induce significant gains in muscle strength, particularly in the knee extensors. However, the parameters of application remain heterogeneous, particularly with regard to the duration of the interventions. With this in mind, a prospective controlled study is being conducted in healthy subjects, comparing four modalities of local vibration intervention targeting the knee extensors: an intensive vibration protocol over 5 consecutive days (1 session of 30 or 60 minutes per day) and a protocol spread over 4 weeks at a rate of 3 weekly sessions of 30 or 60 minutes). The objective is to evaluate and compare their immediate and delayed effects on force production and corticospinal properties. The results of this study will thus help optimize recommendations regarding the use of local vibration in muscle strengthening and neuromuscular reconditioning strategies.

Interventions

  • Device Local vibration protocol
    The vibrations will be delivered using the Vibramoov Physio device, positioned directly on the quadriceps muscle. The participant will be seated comfortably and will remain at rest throughout the session. The vibration settings will be set to an amplitude of 1 mm and a frequency of 100 Hz.

Primary outcome measures

  • Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on the gain in knee extension strength in healthy volunteers. [Time frame: Five times: before the procedure (baseline); at the end of the procedure (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70), and 3 months (day 105 or day 126) after the procedure.]
Secondary outcome measures (7)
  • Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on functional motor abilities and, more specifically, maximum voluntary strength [Time frame: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
  • Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on functional motor skills and, more specifically, jumping performance. [Time frame: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
  • Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on functional motor skills and, more specifically, the rate of force development (RFD) [Time frame: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
  • Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on corticospinal properties and, more specifically, on the level of voluntary activation [Time frame: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
  • Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on corticospinal properties and, more specifically, corticospinal excitability. [Time frame: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
  • Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on corticospinal properties and, more specifically, spinal excitability [Time frame: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
  • Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on corticospinal properties and, more specifically, cortical activation of sensorimotor areas. [Time frame: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]

Eligibility criteria

Inclusion criteria

  • Men and women,
  • Aged between 18 and 45,
  • With a body mass index between 18 and 30 kg/m²,
  • Who have received detailed information about the study and have co-signed the consent form with the investigator,
  • Who are affiliated with or entitled to social security coverage.

Exclusion criteria

  • Subjects with chronic cardiovascular, neuromuscular, bone, metabolic, and/or inflammatory conditions,
  • Personal history and/or risk factors for thrombosis,
  • Subjects undergoing antidepressant treatment,
  • Subjects who have taken corticosteroid treatment in the last 3 months,
  • Use of neuroactive substances likely to alter corticospinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) during the study period,
  • History of bone or ligament trauma to the lower limbs within the last 12 months,
  • Unable to perform the physical efforts required for the study,
  • Engaging in intense and unusual physical activity, including competitive sports, in the month preceding and during the protocol,
  • Presence of a skin lesion at the site where the vibrator is to be placed,
  • Simultaneous participation in another interventional medical trial,
  • Pregnant and breastfeeding women
  • Subjects unable to understand the purpose and conditions of the study, unable to give their consent,
  • Subjects deprived of their liberty or subject to legal protection such as guardianship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07344298 · 25CH170 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗