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Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study.

RecruitingNAAges 18 Years - 80 YearsAllFondazione Don Carlo Gnocchi ETS
NCT07130929 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to evaluate the effectiveness of physiotherapy treatment combined with functional electrical stimulation (FES) in a small group of patients with severe acquired brain injury (SABI) of vascular origin and with a clinical and instrumental diagnosis of "Intensive Care Unit-Acquired Weakness" (ICU-AW). Functional electrical stimulation is a technology that uses electrical impulses, generated by an external device, to reactivate the neuromuscular system through electrodes applied to the skin. In functional electrical stimulation, this process is integrated into physiotherapy sessions, with the active involvement of the patient, through the performance of exercises with the assistance and supervision of the physiotherapist. The rationale behind this is to stimulate neuroplasticity processes by facilitating movement through the application of electrical stimuli and the active pa

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of ischemic or hemorrhagic vascular GCA involving unilateral motor deficit \< 3 months; * Premorbid Modified Rankin Scale \<2; * Age \>18 years and \<80 years; * Level of Cognitive Functioning \> 4 for active participation in treatment. * MRC total sum score \<= 48 (range 0 -60) for clinical suspicion of ICU-AW * Clinical diagnosis of tetra/paraparesis of peripheral origin confirmed by neurophysiological examination; * Signature of informed consent by the patient or, if incapacitated, by their legal representative. Exclusion Criteria: * Clinical cardio-respiratory or internal instability such as to prevent treatment; * History of previous comorbidity for ICU-AW; * Previous known chronic neuropathy; * Severe coagulopathy; * Skin integrity problems at the interface surfaces with the electrostimulator; * Epilepsy not controlled by medication; * Presence of implanted electronic devices; * Pregnancy or breastfeeding; * Severe spasticity with a score of \>3 on the modified Ashworth scale; * Treatment with botulinum toxin; * Recent malignant neoplasm; * Conditions that put you at risk for neuropathies, e.g., history of diabetes mellitus, renal failure, hepatic failure, vitamin deficiencies, chronic alcoholism, vasculitis, previous use of neurotoxic drugs.
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What it tests

  • Functional Electrical Stimulation
  • Conventional physiotherapy
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Where

1 site
IRCCS-Fondazione Don Gnocchi
Florence, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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