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Regaining Walking Ability Easier and Better in Critical Illness Polyneuropathy and Myopathy
The aim of Re-Walk-Easy is to evaluate the effects of rehabilitation based on electrical stimulation on the motor performance of critically ill patients. The study will also investigate the pathophysiology of the two forms-the myopathic-predominant and the polyneuropathic-predominant variants-by examining the longitudinal progression of CIP and CIM and determining which form benefits more from electrical stimulation as a rehabilitative approach.
Although rehabilitation is often recommended to patients with Intensive Care Unit Acquired Weakness (ICU-AW) to counteract the induced muscle weakness, systematic reviews failed to determine its efficacy. Neuro Muscular Electrical Stimulation (NMES) is part of clinical practice in ICU-AW however its effects are still under debate. The investigators hypothesize that this uncertainty stems from the lack of distinction between the two forms of the condition-Critical Illness Polyneuropathy (CIP) and Critical Illness Myopathy (CIM)-which have distinct pathological features and disease trajectories. In addition, the investigators hypothesize that motivating patients by requiring voluntary muscle activation during the Electrical Stimulation (i.e. Functional Electrical Stimulation - FES) will enhance rehabilitation. The study will test the following hypothesis through a longitudinal clinical trial aimed at determining: 1. which form will benefit the most from FES based-rehabilitation, 2. the biomarkers of walking recovery in ICU-AW.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
Yes
IRCCS Fondazione Don Carlo Gnocchi Onlus
Milan, Italy
Start Date
February 25, 2025
Primary Completion Date
December 1, 2027
Completion Date
December 1, 2027
Last Updated
March 3, 2025
72
ESTIMATED participants
Rehabilitation protocol: FES
OTHER
Rehabilitation protocol without FES
OTHER
Rehabilitation protocol: FES
OTHER
Lead Sponsor
Fondazione Don Carlo Gnocchi Onlus
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07017517