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

Official title

Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases (Fit4MedRob-Chronic MND Project)

Overview

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.

Detailed description

Objective: To evaluate the efficacy of a novel rehabilitation protocol integrating advanced technologies in the treatment of chronic 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 chronic 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 chronic NMDs such as Amyotrophic Lateral Sclerosis (ALS), Chronic Inflammatory Demyelinating Polyneuropathy (CIPD) and Charcot-Marie-Tooth neuropathy (CMT). The approach emphasizes rapid rehabilitation to maximize recovery outcomes.

Study Design: An interventional, randomized, pragmatic trial 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 of 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 chronic NMDs. By doing so, it aims to potentially establish a new global standard for the care of patients with NMD care.

Interventions

• Device High-tech rehabilitative treatment
  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
• Other Rehabilitation
  Traditional rehabilitative treatment

Primary outcome measures

• Change from baseline in Fatigue Severity Scale [Time frame: At day 0, at day 15, at day 30, at day 45, at day 60]

Secondary outcome measures (6)

• Change from baseline in Time Up and Go Test [Time frame: At day 0, at day 15, at day 30, at day 45, at day 60]
• Change from baseline in 2-Minute Walking Test [Time frame: 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) [Time frame: At day 0, at day 30 and day 60]
• Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire [Time frame: At day 0, at day 30, at day 60]
• Change from baseline in Charcot-Marie-Tooth disease neuropathy score [Time frame: At day 0, day 30 and day 60]
• Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised [Time frame: At day 0, at day 30 and at day 60]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

Italy · 7 centers

• IRCCS Azienda Ospedaliera Universitaria San Martino - Genova — Genova
• Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute — Milan
• Azienda Ospedaliero-Universitaria di Modena — Modena
• Istituti Clinici Scientifici Maugeri — Montescano
• Istituti Clinici Scientifici Maugeri IRCCS — Pavia
• Fondazione Don Carlo Gnocchi Onlus — Roma
• Istituti Clinici Scientifici Maugeri IRCCS — Telese Terme

Identifiers

NCT: NCT06881979 · 2025_0003585 · PNC0000007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗