Study of Local Vibration Therapy on Dorsiflexor Muscles to Improve Walking Recovery in Subacute Stroke Patients
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-12-04
70
Participants Needed
7
Research Sites
18 weeks
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Effects of Local Vibrations Program of Dorsiflexor Muscles on Neuromotor Recovery in Subacute Stroke Patients.
Research Team
B
Bruno FERNANDEZ, MD
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Stroke patients in subacute rehabilitation phase (between 14 days and 3 months post-stroke)
Diagnosed with ischemic or hemorrhagic stroke
Lower-limb weakness with initial motor testing less than 4 on the MRC scale
No other neurological history with functional impact besides stroke
Provided informed consent or consent with guardian assistance if under guardianship
Affiliated or entitled to a social security scheme
You will not qualify if you...
History of multiple strokes
Other neurological, cognitive, or psychiatric conditions
Orthopedic ankle problems affecting measurements
Received botulinum toxin injections in lower limbs before the study
Presence of phlebitis or risk of thrombosis in lower limbs
Under legal tutorship
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Implementation
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)
Monitoring
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
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.
Hugo Bessaguet, Bruno Fernandez, Vincent Malejac...