High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project

Recruiting now · Not applicable

Conditions studied: Critical Illness Myopathy, Guillain Barré Syndrome, Critical Illness Polyneuromyopathy (CIPNM)

In brief

The goal of this study is determine if a high-tech rehabilitation circuit is more effective than usual rehabilitation methods in improving functional outcome, particularly balance control, for patients with acute neuromuscolar diseases. The main question it aims to answer is: Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, more effective than traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with acute neuromuscular diseases (NMDs)? Researchers will compare a robotic treatment group, that consists in an high-tech rehabilitation, with a control group, that will receive the traditional rehabilitative treatment.

Key facts

Study ID

NCT06822231

Run by

Istituti Clinici Scientifici Maugeri SpA

People needed

124

Starts

2025-05-28

Expected to finish

2026-11-01

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with ages ranging from 18 to 80 years.
• Patients with a confirmed diagnosis of acute/subacute neuromuscular diseases (e.g. GBS, CIM, CIP)
• Time of onset ranging from 15 to 30 days
• Patients with lower limb strength (Medical Research Council or MRC) >=2 in at least two of the flexor and extensor muscles of the following joints: hip, knee and ankle
• Possibility of obtaining informed consent

You may not qualify if…

• Patients with unstable medical conditions (e.g. severe cardiovascular diseases, such as "New York Heart Association" - NYHA=4, respiratory distress not compensated by ventilation) that could interfere, in the clinician's judgment, with their ability to safely participate in the study or to perform the assessments related to the protocol.
• Patients currently participating in other clinical trials that could interfere with this study.
• Pregnant or breastfeeding women.

Where it is running

• Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute — Milan, Italy (enrolling)
• IRCCS Azienda Ospedaliera Universitaria San Martino - Genova — Genova, Italy
• Azienda Ospedaliero-Universitaria di Modena — Modena, Italy
• Istituti Clinici Scientifici Maugeri — Montescano, Italy
• Istituti Clinici Scientifici Maugeri — Pavia, Italy
• Fondazione Don Carlo Gnocchi Onlus — Roma, Italy
• Istituti Clinici Scientifici Maugeri — Bari, Italy
• Istituti Clinici Scientifici Maugeri — Telese Terme, Italy

Full record on ClinicalTrials.gov

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