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

NCT06881979 | Recruiting

• 2 other identifiers: 2025_0003585PNC0000007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective is to demonstrate, in a population of chronic neuromuscular disease the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the level of fatigue. The main question it aims to answer is: Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, not inferior to traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with chronic 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

Amyotrophic Lateral Sclerosis; Chronic Inflammatory Demyelinating Neuropathy; Charcot-Marie-Tooth Disease

Keywords

high-tech rehabilitation; chronic neuromuscular disease; robotic platform

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Fatigue Severity Scale

  The Fatigue Severity Scale questionnaire contains nine statements that rate the severity of the fatigue symptoms (from 1 to 7, where 1 means complete disagreement with the statement and 7 means complete agreement).

  At day 0, at day 15, at day 30, at day 45, at day 60

Secondary Outcomes (6)

• Change from baseline in Time Up and Go Test

  At day 0, at day 15, at day 30, at day 45, at day 60

• Change from baseline in 2-Minute Walking Test

  At day 0, at day 15, at day 30, at day 45, at day 60

• Change from baseline in 12-Item Short Form Survey (SF-12)

  At day 0, at day 30 and day 60

• Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire

  At day 0, at day 30, at day 60

• Change from baseline in Charcot-Marie-Tooth disease neuropathy score

  At day 0, day 30 and day 60

Other Outcomes (4)

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

  At day 0, at day 15, at day 30, at day 60

• Change from baseline in Neurofilament-Light chain

  At day 0, at day 15, at day 30, at day 60

• Change from baseline in Sarcopenia level

  At day 0, at day 30 and day 60

Study Arms (2)

Robotic treatment group

ACTIVE COMPARATOR

In this arm, patients will undergo in motor and cognitive exercise using the VR device (e.g., VRRS EVO), treatment with proprioceptive exercises on a platform (e.g., GEA MASTER or PROKIN Technobody) to enhance postural control, aerobic exercises on a robotic treadmill (e.g. Walkerview Technobody) and usual physiotherapy treatment, such as passive and active assisted exercises

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

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:

• Patients with a confirmed diagnosis of chronic neuromuscular diseases (e.g. ALS, CIDP, CMT)
• Patient able to walk independently or with assistance
• Patients capable of understanding and adhering to the study protocol.
• Patients who have provided informed consent to participate in the study

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 women.

Sponsors & Collaborators

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

Study Sites (7)

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 IRCCS

Pavia, 27100, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi Onlus

Roma, 00135, Italy

NOT YET RECRUITING

Istituti Clinici Scientifici Maugeri IRCCS

Telese Terme, 82037, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Charcot-Marie-Tooth Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Polyneuropathies; Peripheral Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

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
• Masking Details: Masking Description
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: April 28, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)