Rehabilitation protocol: FESRehabilitation protocol without FESRehabilitation protocol: FES
Rehabilitation protocol: FES: Subjects diagnosed with CIP will follow the FES-based rehabilitation protocol
Rehabilitation protocol without FES: Subjects belonging to the control group will follow the rehabilitation protocol without FES
Rehabilitation protocol: FES: Subjects diagnosed with CIM will follow the FES-based rehabilitation protocol
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
Critical Illness Patient Inclusion Criteria:
* clinical diagnosis of tetra/paraparesis of peripheral origin as disclosed by ENG/EMG examination;
* be independent before the episode of critical illness
Critical Illness Patient Exclusion Criteria:
* history of previous comorbidity for ICU-AW;
* previous known chronic polyneuropathy;
* severe coagulopathy;
* severe disorder of consciousness;
* contraindications to Electrical Stimulation application
Healthy Subjects Exclusion Criteria:
* Prosthetic implants
* musculoskeletal, neurological, cardiovascular and pulmonary disorders that may alter the gait
Primary outcome measure(s)
Medical Research Council - Sum Score (MRC-SS) — Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3) The scale measures six bilateral muscle groups (wrist flexion, elbow flexion, shoulder abduction, ankle dorsiflexion, knee extension and hip flexion) with a maximum score of 60 points (normality) and a minimum score of 0 points (No muscle contraction visible or palpable).
Trial sites (1)
Facility
City
Region
Status
IRCCS Fondazione Don Carlo Gnocchi Onlus
Milan
Italy
Recruiting
More Fondazione Don Carlo Gnocchi ETS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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