Image

Improved Recovery of Walking in Acquired Muscle Weakness

Improved Recovery of Walking in Acquired Muscle Weakness

Recruiting
18-85 years
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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

Study details
    Critical Illness Myopathy
    Critical Illness Polyneuropathy

NCT06786390

Fondazione Don Carlo Gnocchi Onlus

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.