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

Official title

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

Overview

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.

Interventions

• Device Vibration
  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
• Device Sham vibration
  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.
• Other 10 meters Walk Test
  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.
• Other 2 Minute Walk Test (2MWT)
  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.
• Other Fugl-Meyer (FMA-LE)
  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
• Other Modified Ashworth scale
  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
• Other ABILOCO questionnaire
  The ABILOCO questionnaire evaluate the autonomy in the walking capacities of the patients (13-items)
• Other Barthel index
  The Barthel index measure autonomy in daily life.
• Other isometric ergometer
  Evaluate voluntary maximum force in isometric ankle dorsiflexion by Cybex isometric ergometer results.
• Other Electromyograms (EMG)
  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.

Primary outcome measures

• Gait speed by 10 meters Walk Test (in meter /second) results [Time frame: Month 2]

Secondary outcome measures (11)

• Walking performance by 10 meters Walk Test (in meter /second) results [Time frame: Month 0, 1, 2, 3, 4]
• Walking performance by 2 Minute Walk Test (2MWT) (in meter) results [Time frame: Month 0, 1, 2, 3, 4]
• Walking performance by Quantified Gait Analysis results [Time frame: Month 2, 4]
• Motor function of the paretic lower limb [Time frame: Month 4]
• Lower limb spasticity level [Time frame: Month 4]
• Autonomy in walking activities [Time frame: Month 4]
• Lower limb strength [Time frame: Month 4]
• Neuromuscular fatigue (1) [Time frame: Month 4]
• Neuromuscular fatigue (2) [Time frame: Month 4]
• Neuromuscular fatigue (3) [Time frame: Month 4]
• Neuromuscular fatigue (4) [Time frame: Month 4]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

France · 7 centers

• Centre Hospitalier Georges Claudinon — Le Chambon-Feugerolles
• Hôpital Marrel — Rive-de-Gier
• Centre Hospitalier de Roanne — Roanne
• Service de SSR Val-Rosay — Saint-Didier-au-Mont-d'Or
• Hôpital Bellevue, CHU de Saint-etienne — Saint-Etienne
• Service de SSR du Centre Le Clos Champirol — Saint-Etienne
• Hospices Civils de Lyon, site Henry Gabrielle — Saint-Genis-Laval

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. PMID 40335131

Identifiers

NCT: NCT05945212 · 21PH266 · 2023-A00489-36

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗