High-tech rehabilitation program for adults with acute neuromuscular disease

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

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 it's running

• Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
  Milan, Italy Recruiting
• Istituti Clinici Scientifici Maugeri
  Bari, Italy Not yet 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
  Pavia, Italy Not yet recruiting

Study contacts

• Study coordinator: Christian Lunetta, MD
• Email: christian.lunetta@icsmaugeri.it
• Phone: +39 0250725266

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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.