NCT06822231

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objective: To evaluate the efficacy of a novel rehabilitation protocol integrating advanced technologies in the treatment of acute neuromuscular diseases (NMDs). Background: NMDs affect muscle function and are directly controlled by the nervous system. Traditional rehabilitation often falls short in addressing the multifaceted needs of NMD patients. This gap underscores the necessity for innovative rehabilitation approaches that can significantly enhance the quality of life and optimize recovery outcomes following acute events. Methods: The protocol integrates advanced technologies to address the rehabilitation needs of patients with acute NMDs. It utilizes robotic systems to ensure consistent and precise movement, virtual reality for immersive and engaging therapy, and stabilometric platforms to enhance balance training. The focus is on acute NMDs such as Guillain-Barré Syndrome (GBS), Critical illness myopathy (CIM) and polyneuropathy (CIP), either individually or in combination (CIP/CIM). The approach emphasizes rapid rehabilitation to maximize recovery outcomes. Study Design: An interventional, randomized, superiority case-control study with a parallel assignment. The trial aims to compare the efficacy of high-tech rehabilitation methods against conventional treatments in improving patient outcomes. Outcome Measures: To assess the improvement at least 10 points in balance measured using the Berg Balance Scale (BBS) from baseline to the end of the treatment period comparing the high-tech rehabilitation circuit with standard rehabilitation protocol. Conclusion: This protocol seeks to determine if high-tech rehabilitation interventions can outperform traditional methods in acute NMDs. By doing so, it aims to potentially establish a new global standard for the care of patients with NMD care.

Conditions

• Critical Illness Myopathy
• Guillain Barré Syndrome
• Critical Illness Polyneuromyopathy (CIPNM)

Interventions

Type	Name	Description
DEVICE	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
OTHER	Rehabilitation	Traditional rehabilitative treatment

Timeline

• Start date: 2025-05-28
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-02-12
• Last updated: 2026-03-03

Locations

8 sites across 1 country: Italy