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

Recruiting now · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis, Chronic Inflammatory Demyelinating Neuropathy, Charcot-Marie-Tooth Disease

In brief

The primary objective is to demonstrate, in a population of chronic neuromuscular disease the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the level of fatigue. The main question it aims to answer is: Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, not inferior to traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with chronic 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

NCT06881979

Run by

Istituti Clinici Scientifici Maugeri SpA

People needed

60

Starts

2025-04-28

Expected to finish

2026-03-01

Last updated by the study team

2025-06-11

Who can join

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

You may qualify if…

• Patients with a confirmed diagnosis of chronic neuromuscular diseases (e.g. ALS, CIDP, CMT)
• Patient able to walk independently or with assistance
• Patients capable of understanding and adhering to the study protocol.
• Patients who have provided informed consent to participate in the study

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 women.

Where it is running

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

Full record on ClinicalTrials.gov

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