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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIstituti Clinici Scientifici Maugeri SpA

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • High-tech rehabilitative treatment
  • Rehabilitation

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Istituti Clinici Scientifici Maugeri SpA

Lead sponsor

Azienda Ospedaliero-Universitaria di Modena

Collaborator

Fondazione Don Carlo Gnocchi Onlus

Collaborator

Ospedale Policlinico San Martino

Collaborator