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 type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 7 sites (Genova and 6 other locations) |
| Status | Recruiting |
| Started | April 28, 2025 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT06881979 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
- Study coordinator: Christian Lunetta, MD
- Email: christian.lunetta@icsmaugeri.it
- Phone: +39 0250725266
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Implanted Brain-Computer Interface to Help People with Severe Arm Impairment
We’re testing the N1 System, a fully implanted brain interface in the motor cortex with a robot, to see if it can help adults with spinal cord injury, ALS, or chronic stroke use a computer or keyboard more easily.
-
Brain-computer interface chat tool for people with ALS
This test compares a wearable brain-computer interface communication device to eye-tracking devices that people with ALS currently use to help them communicate.
-
BIIB147 safety and how it behaves in adults with ALS
This study tests BIIB147 in adults with ALS to see if it is safe and how the body handles it, including early and long-term effects.
-
Aims to restore UNC13A function in people with ALS
This trial tests TRCN-1023 in adults with ALS to see if it’s safe, tolerated, and shows early signs of benefit.
-
LTX-002 in adults with ALS
A study will test whether the experimental drug LTX-002 is safe and tolerable in adults with ALS and see how the body handles the drug and how it affects ALS indicators.
-
Repeated ultrasound-assisted blood-brain barrier opening in ALS
This trial tests whether repeatedly opening the blood-brain barrier with ultrasound is safe and may help people with ALS.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.