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

Last updated: March 2, 2026
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dystonias

Peripheral Neuropathy

Neuropathy

Treatment

Rehabilitation

High-tech rehabilitative treatment

Clinical Study ID

NCT06822231
2024_0053110
PNC0000007
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 leasttwo of the flexor and extensor muscles of the following joints: hip, knee and ankle

  • Possibility of obtaining informed consent

Exclusion

Exclusion Criteria:

  • Patients with unstable medical conditions (e.g. severe cardiovascular diseases, suchas "New York Heart Association" - NYHA=4, respiratory distress not compensated byventilation) that could interfere, in the clinician's judgment, with their abilityto safely participate in the study or to perform the assessments related to theprotocol.

  • Patients currently participating in other clinical trials that could interfere withthis study.

  • Pregnant or breastfeeding women.

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Rehabilitation
Phase:
Study Start date:
May 28, 2025
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • Istituti Clinici Scientifici Maugeri

    Bari, 70124
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri

    Bari 3182351, 70124
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliera Universitaria San Martino - Genova

    Genova, 16132
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliera Universitaria San Martino - Genova

    Genova 8969657, 16132
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute

    Milan, 20138
    Italy

    Active - Recruiting

  • Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute

    Milan 3173435, 20138
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41126
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena

    Modena 3173331, 41126
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri

    Montescano, 27040
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri

    Montescano 6534564, 27040
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri

    Pavia, 27100
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri

    Pavia 3171366, 27100
    Italy

    Site Not Available

  • Fondazione Don Carlo Gnocchi Onlus

    Roma, 00135
    Italy

    Site Not Available

  • Fondazione Don Carlo Gnocchi Onlus

    Roma 8957247, 00135
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri

    Telese Terme, 82037
    Italy

    Site Not Available

  • Istituti Clinici Scientifici Maugeri

    Telese Terme 3165842, 82037
    Italy

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.