Clinical trial NCT05945212: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: Local vibration
Stroke
Motor recovery
Walking speed
Gait
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2023-07-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Stroke patients in subacute rehabilitation phase (between 14 days and 3 months post-stroke)
* First hemispheric, ischemic or hemorrhagic stroke
* 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.

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 a skin lesion close to the site for the placement of the stimulator
* Patient under tutorship or curatorship

Primary outcomes:
measure: Gait speed by 10 meters Walk Test (in meter /second) results
timeFrame: Month 2
Secondary outcomes:
measure: Walking performance by 10 meters Walk Test (in meter /second) results
timeFrame: Month 0, 1, 2, 3, 4
measure: Walking performance by 2 Minute Walk Test (2MWT) (in meter) results
timeFrame: Month 0, 1, 2, 3, 4
measure: Walking performance by Quantified Gait Analysis results
timeFrame: Month 2, 4
measure: Motor function of the paretic lower limb
timeFrame: Month 4
measure: Lower limb spasticity level
timeFrame: Month 4
measure: Autonomy in walking activities
timeFrame: Month 4
measure: Lower limb strength
timeFrame: Month 4
measure: Neuromuscular fatigue (1)
timeFrame: Month 4
measure: Neuromuscular fatigue (2)
timeFrame: Month 4
measure: Neuromuscular fatigue (3)
timeFrame: Month 4
measure: Neuromuscular fatigue (4)
timeFrame: Month 4
Other outcomes:
Locations:
city: Le Chambon-Feugerolles
country: France
facility: Centre Hospitalier Georges Claudinon
city: Rive-de-Gier
country: France
facility: Hôpital Marrel
city: Roanne
country: France
facility: Centre Hospitalier de Roanne
city: Saint-Didier-au-Mont-d'Or
country: France
facility: Service de SSR Val-Rosay
city: Saint-Genis-Laval
country: France
facility: Hospices Civils de Lyon, site Henry Gabrielle
city: Saint-Étienne
country: France
facility: Hôpital Bellevue, CHU de Saint-etienne
city: Saint-Étienne
country: France
facility: Service de SSR du Centre Le Clos Champirol
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Bruno FERNANDEZ, MD
role: PRINCIPAL_INVESTIGATOR
References: