Clinical trial NCT06881979: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Chronic Inflammatory Demyelinating Neuropathy
Charcot-Marie-Tooth Disease
Keywords: high-tech rehabilitation
chronic neuromuscular disease
robotic platform
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Ospedale Policlinico San Martino
name: Azienda Ospedaliero-Universitaria di Modena
name: Fondazione Don Carlo Gnocchi Onlus
First posted: 2025-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Model Description
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Change from baseline in Fatigue Severity Scale
timeFrame: At day 0, at day 15, at day 30, at day 45, at day 60
Secondary outcomes:
measure: Change from baseline in Time Up and Go Test
timeFrame: At day 0, at day 15, at day 30, at day 45, at day 60
measure: Change from baseline in 2-Minute Walking Test
timeFrame: At day 0, at day 15, at day 30, at day 45, at day 60
measure: Change from baseline in 12-Item Short Form Survey (SF-12)
timeFrame: At day 0, at day 30 and day 60
measure: Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire
timeFrame: At day 0, at day 30, at day 60
measure: Change from baseline in Charcot-Marie-Tooth disease neuropathy score
timeFrame: At day 0, day 30 and day 60
measure: Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised
timeFrame: At day 0, at day 30 and at day 60
Other outcomes:
measure: Change from baseline in Insulin Growth Factor 1 and free Insulin Growth Factor 1
timeFrame: At day 0, at day 15, at day 30, at day 60
measure: Change from baseline in Neurofilament-Light chain
timeFrame: At day 0, at day 15, at day 30, at day 60
measure: Change from baseline in Sarcopenia level
timeFrame: At day 0, at day 30 and day 60
measure: Change from baseline in Sarcopenia level
timeFrame: At day 0, at day 15, at day 30 and day 60
Locations:
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
city: Milano
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
city: Montescano
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
city: Roma
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus
city: Telese Terme
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
Study officials:
References: