High-tech rehabilitation program for adults with chronic neuromuscular diseases
Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases (Fit4MedRob-Chronic MND Project)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 7 sites (Genova and 6 other locations) |
| Trial ID | NCT06881979 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Genova and 6 other locations
- IRCCS Azienda Ospedaliera Universitaria San Martino - Genova — Genova, Italy (Not_yet_recruiting)
- Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute — Milan, Italy (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)
- Istituti Clinici Scientifici Maugeri IRCCS — Telese Terme, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Christian Lunetta, MD
- Email: christian.lunetta@icsmaugeri.it
- Phone: +39 0250725266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.