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Clinical Trial Summary

Since the onset of the Coronavirus pandemic disease 2019 (COVID-19), the Lombardy region and in particular the territory of the province of Brescia has been heavily affected. Current data show that the total number of confirmed cases in Italy of COVID-19 due to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) exceeds 3.9 million cases, with more than 120 thousand deaths. As the COVID-19 epidemic continues to spread globally, more and more evidence is being gathered about the presence of neurological manifestations and symptoms associated with it. With the growing understanding of the disease, many non-pulmonary symptoms have been recognized, including neurological complications such as acute cerebrovascular disease, meningitis, encephalitis, and peripheral nervous system disease. The main objective of this study is to analyze the clinical and functional conditions of COVID-19 patients with an associated diagnosis of polyneuropathy who were admitted for rehabilitation in the rehabilitation centers of Brescia.


Clinical Trial Description

The study will be conducted in all the centers considered following the same protocol based on data collection of COVID-19 patients with an associated diagnosis of polyneuropathy. Demographic information, clinical manifestations, laboratory results, electromyography (EMG), neuroimaging, and outcomes will be extracted from the medical records using a standardized data collection form. The data collection will be divided into demographic and clinical data, instrumental examinations, and functional assessment. In the section of demographic data will be collected information regarding age, sex, comorbidities (diabetes mellitus, dyslipidemia, hypertension, coronary artery disease, neoplasia, renal failure, anxiety-depressive syndrome or similar Etc. ), administration during hospitalization of antibiotics, antivirals, mechanical ventilation (invasive / non-invasive; Number of days of mechanical ventilation), pronation cycles (Yes / No), oxygen therapy (Yes / No; Number of days of oxygen therapy; L/min), time of hospitalization in an acute care facility (Number of days) and overall hospitalization time (Number of days). Concerning instrumental examinations will be collected data on neuroimaging tests (CT brain, MRI brain) and EMG more precisely: the type of polyneuropathy will be defined (axonal, demyelinating, mixed); the presence of conduction blocks (Yes/No); latency of F responses from posterior tibial; the amplitude of compound motor action potential (cMAP), distal latencies and motor conduction velocity of one nerve in the lower limbs and one in the upper limbs (possibly peroneal and ulnar); the presence of non-registrable responses (Yes/No); the amplitude of sural sensory-motor potential (SAP). Data at admission and discharge will be collected on the: Cumulative Illness Rating Scale (CIRS), Barthel index, Modified Rankin scale (MRS), muscle strength of the four limbs (MRC muscle scale), walking (Autonomous, with aids, not autonomous). In terms of clinical outcomes will be considered the length of rehabilitation hospitalization (Number of days). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05188690
Study type Observational
Source Fondazione Don Carlo Gnocchi Onlus
Contact Paolo Pedersini, MSc
Phone 02 40308244
Email [email protected]
Status Recruiting
Phase
Start date June 1, 2021
Completion date July 31, 2022

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