High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases (Fit4MedRob-Acute MND Project)
Istituti Clinici Scientifici Maugeri SpA
124 participants
May 28, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria3
- 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.
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Interventions
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
Traditional rehabilitative treatment
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT06822231