RecruitingNot ApplicableNCT06822231

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)


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

124 participants

Start Date

May 28, 2025

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

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

DEVICEHigh-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

OTHERRehabilitation

Traditional rehabilitative treatment


Locations(8)

Istituti Clinici Scientifici Maugeri

Bari, Italy

IRCCS Azienda Ospedaliera Universitaria San Martino - Genova

Genova, Italy

Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Istituti Clinici Scientifici Maugeri

Montescano, Italy

Istituti Clinici Scientifici Maugeri

Pavia, Italy

Fondazione Don Carlo Gnocchi Onlus

Roma, Italy

Istituti Clinici Scientifici Maugeri

Telese Terme, Italy

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NCT06822231


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