NCT07344298

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Jan 2028

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

January 7, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

neuromuscular functionlocal vibration protocolknee extensor

Outcome Measures

Primary Outcomes (1)

  • 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.

    The primary endpoint will be the relative change in maximum isometric strength of the knee extensors (expressed as a percentage increased), assessed using an isokinetic dynamometer.

    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 Outcomes (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

    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.

    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)

    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

    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.

    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.

  • +2 more secondary outcomes

Study Arms (4)

Group "5 days and 30 min"

EXPERIMENTAL

Participants will follow a protocol involving local vibration applied to the quadriceps muscle for 5 consecutive days, at a rate of one 30-minute session per day.

Device: Local vibration protocol

Group "5 days and 60 min"

EXPERIMENTAL

Participants will follow a protocol involving local vibration applied to the quadriceps muscle for 5 consecutive days, at a rate of one 60-minute session per day.

Device: Local vibration protocol

Group "4-weeks and 30 min"

EXPERIMENTAL

Participants will follow a protocol involving local vibration applied to the quadriceps muscle over a period of 4 weeks, with 3 weekly sessions of 30 minutes each, for a total of 12 sessions.

Device: Local vibration protocol

Group "4-weeks and 60 min"

EXPERIMENTAL

Participants will follow a protocol involving local vibration applied to the quadriceps muscle over a period of 4 weeks, with 3 weekly sessions of 60 minutes each, for a total of 12 sessions.

Device: Local vibration protocol

Interventions

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.

Also known as: Vibramoov Physio
Group "4-weeks and 30 min"Group "4-weeks and 60 min"Group "5 days and 30 min"Group "5 days and 60 min"

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Study Officials

  • Léonard FEASSON, MD, PhD

    CHU de Saint Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Léonard FEASSON, MD, PhD

CONTACT

Thomas LAPOLE, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a single-center, randomized, controlled trial comparing four groups of healthy volunteers following a protocol involving local vibration applied to the knee extensor muscles of the dominant leg. Two groups will follow a short-term intervention program consisting of 5 consecutive days of 30 or 60 minutes of vibration (5 sessions), while the other two will benefit from a program spread over 4 weeks at a rate of 3 sessions per week of 30 or 60 minutes of vibration (a total of 12 sessions).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

January 22, 2028

Study Completion (Estimated)

January 22, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations