High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases - Fit4MedRob-Chronic MND Project (Fit4MR-ChrMND)

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

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

Treatments: Device: High-tech rehabilitative treatment; Other: Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06881979

PNC0000007 (Other Grant/Funding Number)

2025_0003585

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Robotic treatment group

Active Comparator group

Description:

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

Treatment:

Device: High-tech rehabilitative treatment

Control group

Other group

Description:

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

Treatment:

Other: Rehabilitation