High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project

NCT06822231 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Phase

Not applicable

Started

2025-05-28

Last updated

2026-09-21

Condition(s) studied

Critical Illness MyopathyGuillain Barré SyndromeCritical Illness Polyneuromyopathy (CIPNM)

Investigational drug(s) / intervention(s)

High-tech rehabilitative treatmentRehabilitation

High-tech rehabilitative treatment: Robotic Verticalization System (e.g., Erigo): Assists in regaining upright posture and mobility. Virtual Reality (e.g., VRRS Evo): Provides an engaging and immersive environment for cognitive and motor exercises. Stabilometric Platform (e.g., Gea Master or Prokin Technobody): Used for balance and postural control training. Treadmill System (e.g., Walkerview Technobody): Used for aerobic exercises with gait analysis and feedback

Rehabilitation: Traditional rehabilitative treatment

Study summary

The goal of this study is determine if a high-tech rehabilitation circuit is more effective than usual rehabilitation methods in improving functional outcome, particularly balance control, for patients with acute neuromuscolar diseases. The main question it aims to answer is:

Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, more effective than traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with acute neuromuscular diseases (NMDs)? Researchers will compare a robotic treatment group, that consists in an high-tech rehabilitation, with a control group, that will receive the traditional rehabilitative treatment.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change from baseline in Berg Balance Scale — At the end of treatment at day 60
Improvement in balance measured by the Berg Balance Scale (BBS), with a target improvement of at least 10 points from baseline to the end of the treatment period. BBS is used to objectively determine a patient's ability (or inability) to safely balance during a series of 14 tasks; each task ranks from 0 to 4, with a total score of 56. Higher score indicates the higher level of function.

Trial sites (8)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06822231 on ClinicalTrials.gov ↗ ← All trials in Italy