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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIstituti Clinici Scientifici Maugeri SpA

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • High-tech rehabilitative treatment
  • Rehabilitation

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Istituti Clinici Scientifici Maugeri SpA

Lead sponsor

Ospedale Policlinico San Martino

Collaborator

Azienda Ospedaliero-Universitaria di Modena

Collaborator

Fondazione Don Carlo Gnocchi Onlus

Collaborator