NCT06786390

Improved Recovery of Walking in Acquired Muscle Weakness

Regaining Walking Ability Easier and Better in Critical Illness Polyneuropathy and Myopathy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Critical Illness Myopathy
• Critical Illness Polyneuropathy

Interventions

Type	Name	Description
OTHER	Rehabilitation protocol: FES	Subjects diagnosed with CIP will follow the FES-based rehabilitation protocol
OTHER	Rehabilitation protocol without FES	Subjects belonging to the control group will follow the rehabilitation protocol without FES
OTHER	Rehabilitation protocol: FES	Subjects diagnosed with CIM will follow the FES-based rehabilitation protocol

Timeline

• Start date: 2025-02-25
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-01-22
• Last updated: 2025-03-03

Locations

1 site across 1 country: Italy