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Stroke RehabilitationNEUROVIB-AVCNCT05945212

Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.

A study testing Vibration, 10 meters Walk Test and 2 Minute Walk Test (2MWT) in people with Stroke Rehabilitation, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the vibration intervention proposed in the current study is to allow a better neuromotor recovery in subacute stroke patients when compared with standard rehabilitation alone. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke Rehabilitation
What is being tested?
Vibration, 10 meters Walk Test and 2 Minute Walk Test (2MWT)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
7 sitesFrance
Study dates
12 Mar 2024to 7 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stroke patients in subacute rehabilitation phase (between 14 days and 3 months post-stroke)
  • Presenting with a stroke, ischemic or hemorrhagic
  • Lower-limb deficiency with an initial motor testing < 4 according to the MRC scale
  • No neurological history with functional impact other than stroke
  • Having received informed information about the study and having signed the written consent
  • Affiliated or entitled to a social security scheme.
  • Patients under guardianship may be included; they may give their consent with the assistance of their guardian.
  • If the participant is unable to write, their consent may be given and documented by other appropriate means in the presence of at least one impartial witness. In this case, the witness will sign and date the informed consent document.

Who cannot join

  • Multiple stroke
  • Other neurological, cognitive or psychiatric conditions
  • Orthopedic ankle history compromising measurements
  • Botulinum toxin injected in the lower limb prior the study protocol
  • Patient with phlebitis or risk of thrombosis in the lower limb
  • Patient under tutorship

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bruno FERNANDEZ, MD contact

(0)477120638 ext. +33

bruno.fernandez@chu-st-etienne.fr

7 sites in 1 country

France7 sites, 7 recruiting

  • Centre Hospitalier Georges Claudinon

    Le Chambon-Feugerolles, 42500

    Thibault TRAMOY, MD

    Thibault TRAMOY, MD

    Not yet recruiting

  • Hôpital Marrel

    Rive-de-Gier, 42800

    Kevin STAMPONE, MD

    Kevin STAMPONE, MD

    Recruiting

  • Centre Hospitalier de Roanne

    Roanne, 42300

    Annelise MOULINET, MD

    Not yet recruiting

  • Service de SSR Val-Rosay

    Saint-Didier-au-Mont-d'Or, 69370

    Julie DI MARCO, MD

    Julie DI MARCO, MD

    Not yet recruiting

  • Hôpital Bellevue, CHU de Saint-etienne

    Saint-Etienne, 42100

    Bruno FERNANDEZ, MD

    Bruno FERNANDEZ, MD

    Recruiting

  • Service de SSR du Centre Le Clos Champirol

    Saint-Etienne, 42270

    Alexandre BERTHOLON, MD

    Alexandre BERTHOLON, MD

    Not yet recruiting

  • Hospices Civils de Lyon, site Henry Gabrielle

    Saint-Genis-Laval, 69230

    Sophie JACQUIN COURTOIS, MD PhD

    Sophie JACQUIN COURTOIS, MD PhD

    Not yet recruiting

Other trials in France

About this study

Official title: Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients - a Multicentric Randomized Controlled Study

The aim of the vibration intervention proposed in the current study is to allow a better neuromotor recovery in subacute stroke patients when compared with standard rehabilitation alone. These last years, it has been proven that the solicitation of a muscle using vibrations may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition to a standard rehabilitation program of local vibrations sessions of the dorsiflexor muscles of the paretic limb of stroke patients may allow a better recovery of walking speed (primary outcome). One group using vibrations (i.e. experimental group) and one group with sham vibration (i.e. control group) will take part to this study.

Being tested
Vibration, Sham vibration, 10 meters Walk Test, 2 Minute Walk Test (2MWT), Fugl-Meyer (FMA-LE)
Keywords
Local vibration, Stroke, Motor recovery, Walking speed, Gait
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VibrationDevice

    Also called VIBRAMOOV PHYSIO

    The program will take place over 40 sessions : 5 sessions per week, for 2 months (40 sessions in total over 8 weeks during the hospitalization in the department); this group will benefit from an effective vibration of a frequency of 100Hz

  • Sham vibrationDevice

    The program will take place over 40 sessions: 5 sessions per week, for 2 months (40 sessions in total over 8 weeks during hospitalization in the department); this group will not benefit from effective vibration.

  • 10 meters Walk TestOther

    Short-distance ambulation speed is measurement between 2 markers on the ground 10 meters apart in a corridor with flat ground, the patient starting his walk 3 meters before to have a launched march disregarding markers, and ends 3 meters After. The stopwatch is started when the markers are crossed.

  • 2 Minute Walk Test (2MWT)Other

    Long-distance ambulation speed is measured from a standing start and the test involves asking the patient to walk as far as possible in 2 minutes.

  • Fugl-Meyer (FMA-LE)Other

    The Fugl-Meyer (FMA-LE) assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination. Score from 0 to 34

  • Modified Ashworth scaleOther

    The modified Ashworth scale allows the measurement of spasticity, that is to say the measurement of muscle tone by mobilizing the segment of the lower limb and by evaluating the resistance to stretching of the muscles. Score from 0 to 4

  • ABILOCO questionnaireOther

    The ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)

  • Barthel indexOther

    The Barthel index measure autonomy in daily life.

  • isometric ergometerOther

    Also called Cybex isometric ergometer (Henley Healthcare, Sugarland, TX, USA)

    Evaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.

  • Electromyograms (EMG)Other

    Also called Electrodes Meditrace 100, Covidien, Mansfield, MA

    Assessment of neuromuscular fatigue by electromyograms (EMG). Surface electrodes is place on the tibial muscle anterior to non-invasively collect electromyograms (EMG). The intensity of stimulation will be gradually increased until a plateau in mechanical (strength) and electromyograms (EMG) responses is obtained.

  • Traditional quantified gait analysisOther

    Also called 0D

    Gait kinematics will be recorded on a force platform (90 x 90 cm, Model 9287C, Kistler, Winterthur, Switzerland) to determine: joint angles, net joint moments and powers at the ankle, knee and hip.

  • SPM - Statistical Parametric MappingOther

    Also called 1D

    Addition of a temporal component to the traditional quantified gait analysis, allowing the focus to be on time series parameters.

  • FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)Other

    A short questionnaire consisting of 13 questions to which the patient answers on a scale from 0 to 4. The scores are simply added up, inverting the scale for negative sentences, to give a result out of 52 points. The lower the score, the greater the fatigue.

Study groups in NCT05945212
Study groupRoleWhat they receive
VibrationExperimentalStroke patients in subacute rehabilitation phase will be included. In addition of a subacute post-stroke standard rehabilitation program, they will have a vibration program.
Receives: Device: Vibration; Other: 10 meters Walk Test; Other: 2 Minute Walk Test (2MWT); Other: Fugl-Meyer (FMA-LE); Other: Modified Ashworth scale; Other: ABILOCO questionnaire; Other: Barthel index; Other: isometric ergometer; Other: Electromyograms (EMG); Other: Traditional quantified gait analysis; Other: SPM - Statistical Parametric Mapping; Other: FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)
no vibrationSham comparatorIn addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Receives: Device: Sham vibration; Other: 10 meters Walk Test; Other: 2 Minute Walk Test (2MWT); Other: Fugl-Meyer (FMA-LE); Other: Modified Ashworth scale; Other: ABILOCO questionnaire; Other: Barthel index; Other: isometric ergometer; Other: Electromyograms (EMG); Other: Traditional quantified gait analysis; Other: SPM - Statistical Parametric Mapping; Other: FACIT questionnaire (Functional Assessment of Chronic Illness Therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait speed by 10 meters Walk Test (in meter /second) results

    Analysis Gait speed by 10 meters Walk Test (in meter /second) results

    Measured: Month 2

Secondary outcomes (11)

  1. Walking performance by 10 meters Walk Test (in meter /second) results

    Analysis Walking performance (comfort speed) by 10 meters Walk Test (in meter /second) results

    Measured: Month 0, 1, 2, 3, 4

  2. Walking performance by 2 Minute Walk Test (2MWT) (in meter) results

    Analysis Walking performance (distance) by 2 Minute Walk Test (2MWT) (in meter) results

    Measured: Month 0, 1, 2, 3, 4

  3. Walking performance by Quantified Gait Analysis results

    Walking performance will be assessed using: (in m/s) in the 10-meter test (short distance), distance (in m) covered in a 2-minute walk test (long distance) , and qualitatively by a Quantified Gait Analysis (performed only in M2 and M4).

    Measured: Month 2, 4

  4. Motor function of the paretic lower limb

    The motor function of the paretic lower limb will be measured by the Fugl Meyer Assessment scale for lower limbs (FMA-LE) which includes five domains: Motor skills; Balance skills; Sensitivity; Range of motion; Joint pain. A three-point ordinal scale (0: cannot perform; 1: partially performed; 2: fully performed) is applied to each item. The maximum score is 226.

    Measured: Month 4

  5. Lower limb spasticity level

    The level of spasticity of the lower limb will be measured by the modified Ashworth scale : a 6-point scale with scores ranging from 0 to 4, where the lowest scores represent normal muscle tone and the highest scores represent spasticity or increased resistance to passive movement.

    Measured: Month 4

  6. Autonomy in walking activities

    The patient's autonomy in walking activities will be measured by the ABILOCO questionnaire and in daily living activities by the Barthel index.

    Measured: Month 4

  7. Lower limb strength

    Lower extremity strength will be measured as maximal voluntary strength in isometric ankle dorsiflexion.

    Measured: Month 4

  8. Neuromuscular fatigue (1)

    Neuromuscular fatigue will be assessed by the level of voluntary activation (in %).

    Measured: Month 4

  9. Neuromuscular fatigue (2)

    Neuromuscular fatigue will be assessed by corticospinal and intracortical excitability thanks to electromyographic responses evoked by transcranial magnetic stimulation.

    Measured: Month 4

  10. Neuromuscular fatigue (3)

    Neuromuscular fatigue will be assessed by spinal excitability thanks to electromyographic responses evoked by electrical nerve stimulation.

    Measured: Month 4

  11. Neuromuscular fatigue (4)

    Neuromuscular fatigue will be assessed by perceived subjective fatigue measured by the FACIT questionnaire : the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness, including over 400 questions. Higher scores for the scales and subscales indicate better quality of life.

    Measured: Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start12 Mar 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion7 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05945212
Sponsor's protocol ID
21PH266
Other IDs
2023-A00489-36
Acronym
NEUROVIB-AVC
Status last verified
Oct 2026
First submitted
6 Jul 2023
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data shared: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices)

Publications

  • Bessaguet H, Fernandez B, Malejac V, Nerriere E, Velarde M, Coiffet A, Rimaud D, Lapole T. Effect of tibialis anterior focal muscle vibration for gait rehabilitation in hemiplegic individuals during the subacute phase after stroke: the NEUROVIB-AVC study protocol - a multicentric randomised controlled trial. BMJ Open. 2025 May 6;15(5):e102838. doi: 10.1136/bmjopen-2025-102838.

    PubMed 40335131

Questions about this trial

What is this clinical trial studying?

A study testing Vibration, 10 meters Walk Test and 2 Minute Walk Test (2MWT) in people with Stroke Rehabilitation, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bruno FERNANDEZ, MD ((0)477120638 ext. +33, bruno.fernandez@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait speed by 10 meters Walk Test (in meter /second) results (time frame: Month 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05945212, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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