High-tech rehabilitation program for adults with acute neuromuscular disease
Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases (Fit4MedRob-Acute MND Project)
This trial will test whether a high-tech rehab program using robotics, virtual reality, and balance platforms helps adults with acute neuromuscular conditions improve balance, strength, fatigue, and quality of life more than usual therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 8 sites (Bari and 7 other locations) |
| Trial ID | NCT06822231 on ClinicalTrials.gov |
What this trial studies
This randomized, parallel-assignment study compares a high-tech rehabilitation circuit (robotic systems, virtual reality, stabilometric platforms) to conventional rehabilitation in adults with acute/subacute neuromuscular diseases such as Guillain-Barré syndrome, critical illness myopathy, and critical illness polyneuromyopathy. Participants aged 18–80 within 15–30 days of symptom onset and with minimum preserved lower-limb strength will be randomized to receive either the advanced-technology protocol or standard care. The protocol emphasizes intensive, rapid rehabilitation with repeated, standardized sessions delivered by multidisciplinary teams and uses the Berg Balance Scale and other motor, fatigue, sarcopenia, cognitive engagement, and quality-of-life measures as outcomes. The primary outcome is a predefined improvement in balance (at least 10 points on the Berg Balance Scale) from baseline to end of treatment.
Who should consider this trial
Good fit: Adults 18–80 with a confirmed acute/subacute neuromuscular diagnosis (GBS, CIM, CIP) within 15–30 days of onset, with at least MRC ≥2 in two lower-limb muscle groups and able to give informed consent are ideal candidates.
Not a fit: Patients with unstable medical conditions (for example NYHA class IV heart failure), uncompensated respiratory failure, very low lower-limb strength (MRC <2), pregnant or breastfeeding women, or those enrolled in conflicting trials are unlikely to be eligible or to benefit from the protocol.
Why it matters
Potential benefit: If successful, this program could speed and enhance recovery of balance, strength, and daily function compared with standard rehabilitation for patients with acute neuromuscular diseases.
How similar studies have performed: Related robotic and virtual-reality rehabilitation approaches have shown benefits in stroke and chronic neuromuscular rehabilitation, but rigorous randomized evidence specifically in acute neuromuscular diseases is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with ages ranging from 18 to 80 years. * Patients with a confirmed diagnosis of acute/subacute neuromuscular diseases (e.g. GBS, CIM, CIP) * Time of onset ranging from 15 to 30 days * Patients with lower limb strength (Medical Research Council or MRC) \>=2 in at least two of the flexor and extensor muscles of the following joints: hip, knee and ankle * Possibility of obtaining informed consent 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 or breastfeeding women.
Where this trial is running
Bari and 7 other locations
- Istituti Clinici Scientifici Maugeri — Bari, Italy (Not_yet_recruiting)
- 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 — Pavia, Italy (Not_yet_recruiting)
- Fondazione Don Carlo Gnocchi Onlus — Roma, Italy (Not_yet_recruiting)
- Istituti Clinici Scientifici Maugeri — 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.