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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04014270
Study type Interventional
Source Intento SA
Contact
Status Terminated
Phase N/A
Start date November 8, 2019
Completion date May 22, 2023

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