Stroke Rehabilitation Clinical Trial
Official title:
Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis: A Multi-Centre, Single-Blind, Randomized Parallel Study
The study aims at demonstrating the efficacy of self-modulated functional electrical stimulation (SM-FES) in promoting upper-limb (UL) motor recovery in chronic stroke patients with severe and severe-moderate paralysis. The effect of such experimental therapy will be compared to dose-matched, goal-oriented standard care (SC). SM-FES consists of intensive, goal-oriented, repetitive functional exercises assisted by electrical stimulation. The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. The duration of the intervention is 90 min per day, 5 days per week, for 2 weeks.
After the informed consent process, each centre will screen potential participants according to the inclusion and exclusion criteria. Each recruited participant will be randomly assigned to one group: - experimental group - patients will receive self-modulated functional electrical stimulation SM-FES; - control group - patients will receive standard care SC. This first main phase of the study includes 10 days intervention delivered to the two groups and assessments pre-intervention, post-intervention and after 3 months (follow-up). After the follow-up, participants initially recruited in the control group will be able to enter a secondary exploratory phase and receive further 10 days of treatment with SM-FES. ;
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