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

NCT06822231 | Recruiting

• 2 other identifiers: 2024_0053110PNC0000007
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

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

Keywords

high-tech rehabilitation; acute neuromuscular diseases; robotic platform

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Berg Balance Scale

  Improvement in balance measured by the Berg Balance Scale (BBS), with a target improvement of at least 10 points from baseline to the end of the treatment period. BBS is used to objectively determine a patient's ability (or inability) to safely balance during a series of 14 tasks; each task ranks from 0 to 4, with a total score of 56. Higher score indicates the higher level of function.

  At the end of treatment at day 60

Secondary Outcomes (9)

• Change from baseline in Modified Barthel Index

  At day 15, at day 30, at day 45, at day 60

• Change from baseline in Trunk Control Test

  At day 15, at day 30, at day 45, at day 60

• Change from baseline in 2-Minute Walk Test

  At day 15, at day 30, at day 45, at day 60

• Change from baseline in Modified Erasmus GBS Outcome Score

  At the end of treatment at day 60

• Change from baseline in Handgrip strenght test

  At day 15, at day 30, at day 45, at day 60

Other Outcomes (2)

• Change from baseline in Insulin Growth Factor 1 and free Insulin Growth Factor 1

  At day 15, at day 30, at day 60

• Change from baseline in Neurofilament-Light chain

  At day 15, at day 30, at day 60

Study Arms (2)

Robotic treatment group

ACTIVE COMPARATOR

In this arm, patients will be divided into 3 treatment types based on their Berg Balance Scale (BBS) score at the time of randomization. Phase 1 (BBS \<= 20) involves treatment with a robotic verticalization system (ERIGO) and action observation training with a virtual reality device. Phase 2 (21 \< BBS \< 40) involves treatment with a robotic verticalization system (ERIGO), action observation training with a virtual reality device, and proprioceptive exercises on robotic platforms (e.g. GEA MASTER or PROKIN Technobody). Phase 3 (BBS \>= 41) involves motor and cognitive exercises using virtual reality device, proprioceptive exercises on robotic platforms (e.g. GEA MASTER or PROKIN Technobody), and aerobic exercises on a robotic treadmill (e.g. Walkerview Technobody).

Device: High-tech rehabilitative treatment

Control group

OTHER

The patients will receive the traditional rehabilitative treatment according to the good clinical practice according to the Diagnostic, Therapeutic and Care Pathways of each center involved

Other: Rehabilitation

Interventions

High-tech rehabilitative treatment DEVICE

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

Robotic treatment group

Rehabilitation OTHER

Traditional rehabilitative treatment

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Azienda Ospedaliero-Universitaria di Modena: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Ospedale Policlinico San Martino: collaborator

Study Sites (8)

Istituti Clinici Scientifici Maugeri

Bari, 70124, Italy

NOT YET RECRUITING

IRCCS Azienda Ospedaliera Universitaria San Martino - Genova

Genova, 16132, Italy

NOT YET RECRUITING

Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute

Milan, 20138, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Modena

Modena, 41126, Italy

NOT YET RECRUITING

Istituti Clinici Scientifici Maugeri

Montescano, 27040, Italy

NOT YET RECRUITING

Istituti Clinici Scientifici Maugeri

Pavia, 27100, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi Onlus

Roma, 00135, Italy

NOT YET RECRUITING

Istituti Clinici Scientifici Maugeri

Telese Terme, 82037, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Christian Lunetta, MD

CONTACT

+39 0250725266; christian.lunetta@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 12, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8)