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

NCT05945212 | Recruiting

• 2 other identifiers: 21PH2662023-A00489-36
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Stroke Rehabilitation

Keywords

Local vibration; Stroke; Motor recovery; Walking speed; Gait

Outcome Measures

Primary Outcomes (1)

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

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

  Month 2

Secondary Outcomes (11)

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

  Month 0, 1, 2, 3, 4

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

  Month 0, 1, 2, 3, 4

• Walking performance by Quantified Gait Analysis results

  Month 2, 4

• Motor function of the paretic lower limb

  Month 4

• Lower limb spasticity level

  Month 4

Study Arms (2)

Vibration

EXPERIMENTAL

Stroke patients in subacute rehabilitation phase will be included. In addition of a subacute post-stroke standard rehabilitation program, they will have a vibration program.

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 vibration

SHAM COMPARATOR

In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.

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)

Interventions

Vibration DEVICE

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

Also known as: VIBRAMOOV PHYSIO

Vibration

Sham vibration DEVICE

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.

no vibration

10 meters Walk Test OTHER

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.

Vibration; no vibration

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.

Vibration; no vibration

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

Vibration; no vibration

Modified Ashworth scale OTHER

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

Vibration; no vibration

ABILOCO questionnaire OTHER

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

Vibration; no vibration

Barthel index OTHER

The Barthel index measure autonomy in daily life.

Vibration; no vibration

isometric ergometer OTHER

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

Also known as: Cybex isometric ergometer (Henley Healthcare, Sugarland, TX, USA)

Vibration; no vibration

Electromyograms (EMG) OTHER

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.

Also known as: Electrodes Meditrace 100, Covidien, Mansfield, MA

Vibration; no vibration

Traditional quantified gait analysis OTHER

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.

Also known as: 0D

Vibration; no vibration

SPM - Statistical Parametric Mapping OTHER

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

Also known as: 1D

Vibration; no vibration

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.

Vibration; no vibration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, France: collaborator
• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (7)

Centre Hospitalier Georges Claudinon

Le Chambon-Feugerolles, 42500, France

NOT YET RECRUITING

Hôpital Marrel

Rive-de-Gier, 42800, France

RECRUITING

Centre Hospitalier de Roanne

Roanne, 42300, France

NOT YET RECRUITING

Service de SSR Val-Rosay

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

NOT YET RECRUITING

Hôpital Bellevue, CHU de Saint-etienne

Saint-Etienne, 42100, France

RECRUITING

Service de SSR du Centre Le Clos Champirol

Saint-Etienne, 42270, France

NOT YET RECRUITING

Hospices Civils de Lyon, site Henry Gabrielle

Saint-Genis-Laval, 69230, France

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 40335131 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bruno FERNANDEZ, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno FERNANDEZ, MD

CONTACT

(0)477120638; bruno.fernandez@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: March 12, 2024
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal To achieve aims in the approved proposal Proposals should be directed to corresponding author. To gain access, data requestors will need to sign a data access agreement.

Locations

FR (7)