Local vibrations to improve recovery in stroke patients

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

This study is testing if adding local vibrations to regular rehab can help stroke patients recover their walking speed better than rehab alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (other)
• Locations: 7 sites (Le Chambon-Feugerolles and 6 other locations)
• Trial ID: NCT05945212 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a local vibrations program on the dorsiflexor muscles of subacute stroke patients to enhance neuromotor recovery compared to standard rehabilitation alone. Participants will be divided into two groups: one receiving actual vibrations and the other receiving sham vibrations. The primary outcome measured will be walking speed, assessed through tests such as the 10 meters Walk Test and the 2 Minute Walk Test. The study aims to determine if the addition of vibration therapy can lead to better recovery outcomes in this patient population.

Who should consider this trial

Good fit: Ideal candidates are stroke patients in the subacute rehabilitation phase, specifically those with lower-limb deficiencies and no prior neurological conditions.

Not a fit: Patients with multiple strokes or other neurological, cognitive, or psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve walking speed and overall mobility in stroke patients during their rehabilitation phase.

How similar studies have performed: Other studies have shown positive effects of vibration therapy on neuromuscular function, suggesting potential success for this approach.

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

Where this trial is running

Le Chambon-Feugerolles and 6 other locations

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

Study contacts

• Principal investigator: Bruno FERNANDEZ, MD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Bruno FERNANDEZ, MD

Conditions: Stroke Rehabilitation, Local vibration, Stroke, Motor recovery, Walking speed, Gait