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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Centre Hospitalier Georges Claudinon
NOT_YET_RECRUITING
Le Chambon-feugerolles
Hôpital Marrel
RECRUITING
Rive-de-gier
Centre Hospitalier de Roanne
NOT_YET_RECRUITING
Roanne
Service de SSR Val-Rosay
NOT_YET_RECRUITING
Saint-didier-au-mont-d'or
Hôpital Bellevue, CHU de Saint-etienne
RECRUITING
Saint-etienne
Service de SSR du Centre Le Clos Champirol
NOT_YET_RECRUITING
Saint-etienne
Hospices Civils de Lyon, site Henry Gabrielle
NOT_YET_RECRUITING
Saint-genis-laval
Contact Information
Primary
Bruno FERNANDEZ, MD
bruno.fernandez@chu-st-etienne.fr
(0)477120638
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2027-05-15
Participants
Target number of participants: 70
Treatments
Experimental: Vibration
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.
Sham_comparator: no vibration
In addition of a subacute post-stroke standard rehabilitation program, they will have a sham vibration program.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France

This content was sourced from clinicaltrials.gov