Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

High-tech rehabilitation program for adults with chronic neuromuscular diseases

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

Run by Istituti Clinici Scientifici Maugeri SpA · NCT06881979 · Data updated 2026-11-12

This trial will test whether a high-tech rehab program using robotic systems, virtual reality, and balance platforms works as well as traditional rehab to reduce fatigue and improve function in adults with chronic neuromuscular diseases.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment60 (estimated)
SponsorIstituti Clinici Scientifici Maugeri SpA
Academic / other
Locations7 sites (Genova and 6 other locations)
StatusRecruiting
StartedApril 28, 2025
Main results expectedNovember 2026
Study endsDecember 2026
Registry record updatedNovember 4, 2026
Trial IDNCT06881979 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with a confirmed diagnosis of chronic neuromuscular disease (e.g., ALS, CIDP, CMT) who can walk independently or with assistance, can follow the protocol, and can give informed consent.

Probably not a fit

Patients with unstable medical conditions (for example NYHA class IV heart failure or uncompensated respiratory failure), those unable to tolerate device-based therapy, pregnant women, or those enrolled in conflicting trials are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, pragmatic, parallel-assignment trial compares a high-tech rehabilitation program (robotic devices, virtual reality, and stabilometric platforms) with conventional physiotherapy in adults with chronic neuromuscular diseases such as ALS, CIDP, and Charcot–Marie–Tooth. The primary goal is to show non-inferiority in fatigue levels, while secondary outcomes include balance (Berg Balance Scale), motor function, sarcopenia markers, cognitive engagement, and quality of life. Eligible participants who can walk independently or with assistance are randomized to receive a standardized course of either high-tech or traditional rehabilitation at participating Italian centers. Outcomes are measured from baseline to the end of the intervention period to compare improvements between groups.

Why it matters

Potential benefit: If successful, this approach could provide a more engaging, consistent, and scalable rehabilitation option that reduces fatigue and improves balance, mobility, and quality of life for people with chronic neuromuscular diseases.

How similar studies have gone: Robotic and virtual-reality rehabilitation have shown promise in stroke and other neurological conditions, but high-quality evidence in chronic neuromuscular diseases is limited and mixed.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
    Milan, Italy
    Recruiting
  • IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
    Genova, Italy
    Not yet recruiting
  • Azienda Ospedaliero-Universitaria di Modena
    Modena, Italy
    Not yet recruiting
  • Istituti Clinici Scientifici Maugeri
    Montescano, Italy
    Not yet recruiting
  • Istituti Clinici Scientifici Maugeri IRCCS
    Pavia, Italy
    Not yet recruiting
  • Fondazione Don Carlo Gnocchi Onlus
    Roma, Italy
    Not yet recruiting
Show 1 more location
  • Istituti Clinici Scientifici Maugeri IRCCS
    Telese Terme, Italy
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.