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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Istituti Clinici Scientifici Maugeri SpA • ClinicalTrials.gov ID: NCT06881979

Registry updated: 2026-09-21
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Description

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.

Interventions

  • High-tech rehabilitative treatment (Device)
    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
  • Rehabilitation (Other)
    Traditional rehabilitative treatment

Eligibility criteria

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.

Conditions

Amyotrophic Lateral Sclerosis Chronic Inflammatory Demyelinating Neuropathy Charcot-Marie-Tooth Disease

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record