Actively Recruiting
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-12-04
70
Participants Needed
7
Research Sites
18 weeks
Total Duration
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
Researchers are investigating whether adding local vibration sessions to the dorsiflexor muscles of the affected leg can improve neuromotor recovery in patients who are in the subacute phase after a stroke. This study compares two groups of stroke patients: one receiving vibration therapy alongside standard rehabilitation and the other receiving sham vibration with standard rehabilitation. The main goal is to see if this vibration program can help patients walk faster. The treatment involves 40 sessions over 8 weeks during hospitalization, with five sessions per week. One group receives actual vibration therapy at a frequency of 100Hz on the dorsiflexor muscles, while the other group receives sham vibration without effective stimulation. Both groups also continue with the usual rehabilitation program for stroke recovery. Participants will undergo various assessments including walking speed measured by a 10-meter walk test at 2 months, and other walking performance tests over several months. Additional evaluations include motor function, spasticity, autonomy in walking, muscle strength, and neuromuscular fatigue using tools like electromyograms and gait analysis. These tests occur at different timepoints up to 4 months to monitor recovery and treatment effects.
CONDITIONS
Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 8 weeks
Participants undergo a vibration program consisting of 40 sessions over 8 weeks during hospitalization, with either effective vibration or sham vibration applied to dorsiflexor muscles in addition to standard rehabilitation.
5 sessions per week for 8 weeks (40 sessions total)
Duration - Up to 4 months
Participants are assessed on walking performance, motor function, spasticity, autonomy, strength, and neuromuscular fatigue through various tests and questionnaires.
Assessments at Month 0, 1, 2, 3, and 4 including 10 meters Walk Test, 2 Minute Walk Test, gait analysis, motor function tests, and questionnaires
Total: 7 locations
1
Centre Hospitalier Georges Claudinon
Le Chambon-Feugerolles, France, 42500
Not Yet Recruiting
2
Hôpital Marrel
Rive-de-Gier, France, 42800
Actively Recruiting
3
Centre Hospitalier de Roanne
Roanne, France, 42300
Not Yet Recruiting
4
Service de SSR Val-Rosay
Saint-Didier-au-Mont-d'Or, France, 69370
Not Yet Recruiting
5
Hôpital Bellevue, CHU de Saint-etienne
Saint-Etienne, France, 42100
Actively Recruiting
6
Service de SSR du Centre Le Clos Champirol
Saint-Etienne, France, 42270
Not Yet Recruiting
7
Hospices Civils de Lyon, site Henry Gabrielle
Saint-Genis-Laval, France, 69230
Not Yet Recruiting
B
Bruno FERNANDEZ, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Hugo Bessaguet, Bruno Fernandez, Vincent Malejac...
https://pubmed.ncbi.nlm.nih.gov/40335131