What is this study trying to find out about acute neuromuscular diseases?

This study is evaluating if high-tech rehabilitation methods using robotics, virtual reality, and balance platforms improve balance, motor skills, fatigue, muscle health, and quality of life better than traditional rehabilitation for patients with acute neuromuscular diseases. The research is sponsored by Istituti Clinici Scientifici Maugeri SpA and aims to enhance recovery options for these patients.

Who may be eligible for this acute neuromuscular disease clinical trial?

Adults aged 18 to 80 years with a confirmed diagnosis of acute or subacute neuromuscular diseases like Guillain-Barre9 Syndrome, Critical Illness Myopathy, or Critical Illness Polyneuropathy may be eligible. Participants must have muscle strength of at least 2 in key lower limb muscles and be within 15 to 30 days of disease onset. Please review eligibility criteria for more details.

Is there any cost to participate in this acute neuromuscular disease clinical trial?

Study-related care, including the study devices and all trial visits, is provided at no cost. Personal travel and accommodation expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any associated travel costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

ID06822231

Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases Fit4MedRob-Acute MND Project

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-03-03

124

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether a high-tech rehabilitation circuit is more effective than traditional rehabilitation methods for improving function, especially balance control, in patients with acute neuromuscular diseases NMDs. The study focuses on conditions such as Guillain-Barre9 Syndrome GBS, Critical Illness Myopathy CIM, and Critical Illness Polyneuropathy CIP, aiming to improve motor function, fatigue, muscle loss, cognitive engagement, and overall quality of life. The study compares two groups one receiving high-tech rehabilitation using robotic verticalization systems, virtual reality devices, stabilometric platforms, and robotic treadmills, and a control group receiving standard rehabilitation care. The high-tech group is further divided into three phases based on balance ability measured by the Berg Balance Scale, with treatments tailored accordingly. The intervention lasts up to 60 days. Participants will undergo assessments of balance, motor function, walking ability, muscle strength, fatigue, and quality of life at multiple time points during the 60-day treatment period. Researchers will measure changes in balance using the Berg Balance Scale as the primary outcome. Secondary outcomes include functional independence, trunk control, walking tests, and patient perception of the rehabilitation technology. Safety and adherence will also be monitored throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 80 years
Confirmed diagnosis of acute or subacute neuromuscular diseases such as Guillain-Barr�e9 Syndrome, Critical Illness Myopathy, or Critical Illness Polyneuropathy
Onset of symptoms between 15 and 30 days before enrollment
Lower limb muscle strength of at least 2 (Medical Research Council scale) in at least two flexor and extensor muscles of the hip, knee, and ankle joints
Ability to provide informed consent

You will not qualify if you...

Unstable medical conditions such as severe cardiovascular disease (NYHA class 4) or respiratory distress not managed by ventilation
Participation in other clinical trials that could interfere with this study
Pregnant or breastfeeding women

Research Team

Christian Lunetta, MD

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