RECRUITINGINTERVENTIONAL

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

Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases (Fit4MedRob-Chronic MND Project)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form to participate in the study Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Treatments Being Tested

DEVICE

High-tech rehabilitative treatment

Virtual Reality (e.g., VRRS Evo): Provides an engaging and immersive environment for cognitive and motor exercises. Stabilometric Platform (e.g., Gea Master or Prokin Technobody): Used for balance and postural control training. Treadmill System (e.g., Walkerview Technobody): Used for aerobic exercises with gait analysis and feedback

OTHER

Rehabilitation

Traditional rehabilitative treatment

Locations (7)

IRCCS Azienda Ospedaliera Universitaria San Martino - Genova

Genova, Italy

Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Istituti Clinici Scientifici Maugeri

Montescano, Italy

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Italy

Fondazione Don Carlo Gnocchi Onlus

Roma, Italy

Istituti Clinici Scientifici Maugeri IRCCS

Telese Terme, Italy