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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06881979
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Fatigue Severity Scale	At day 0, at day 15, at day 30, at day 45, at day 60	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).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Time Up and Go Test	At day 0, at day 15, at day 30, at day 45, at day 60	Timed Up and Go Test (TUG) is a simple test used to assess mobility, balance and locomotor performance. It uses the time that a person need to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair and sit down while turning 180 degrees. The shorter the time taken to perform the test, the better the patient's mobility.
Change from baseline in 2-Minute Walking Test	At day 0, at day 15, at day 30, at day 45, at day 60	The Two-Minute Walk Test (2MWT) is a simple and quick assessment used to measure a person's walking endurance and functional mobility. It is based on the measurement of the distance that a person can walk in two minutes. The individual is instructed to walk as far as possible in two minutes, typically along a marked course. Assistive devices can be used if needed but should be kept consistent across tests. The total distance walked in meters is recorded.
Change from baseline in 12-Item Short Form Survey (SF-12)	At day 0, at day 30 and day 60	The SF-12 is a self-reported questionnaire designed to measure health-related quality of life. It is a shortened version of the SF-36, created to reduce the burden on respondents while still providing reliable and valid results. The SF-12 covers eight health domains: Physical functioning; Role-physical (limitations due to physical health problems); Bodily pain; General health; Vitality (energy and fatigue); Social functioning; Role-emotional (limitations due to emotional problems); Mental health (psychological distress and well-being). The survey produces two summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). These scores are norm-based, with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better-than-average health related quality of life, while scores below 50 suggest below-average health.
Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire	At day 0, at day 30, at day 60	To assess the patient perception of the technology assisted rehabilitation using the Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). The TARPP-Q consists of 10 questions with multiple choice answers, totalling 29 items. The Questionnaire assesses patients' personal experiences and perceptions of technology assisted rehabilitation, including aspects like usability, positive attitude, hindrance perception, and distress.
Change from baseline in Charcot-Marie-Tooth disease neuropathy score	At day 0, day 30 and day 60	The Charcot-Marie-Tooth Neuropathy Score (CMTNS) is a clinical scale used to assess the severity of Charcot-Marie-Tooth neuropathy. This scale is used both to monitor disease progression and to assess the effectiveness of potential experimental treatments. Consists of 9 items, grouped into 3 major categories: Patient-Reported Symptoms, Clinical Examination and Electrophysiological data. Each item is scored from 0 to 4, where 0 means no impairment and 4 very severe impairment, with a total score ranges from 0 to 36.
Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised	At day 0, at day 30 and at day 60	The Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) is a scale that includes 12 questions, related to bulbar, motor and respiratory function. This scale is commonly used to evaluate the severity and progression of Amyotrophic Lateral Sclerosis. Each item can have a score from 0 to 4, with a maximum total score of 48, where a score of 0 would indicate no function while a score of 4 would indicate normal function.

Trial Locations

Locations (6)

Istituti Clinici Scientifici Maugeri IRCCS; 🇮🇹 Telese Terme, Italy

Fondazione Don Carlo Gnocchi Onlus; 🇮🇹 Roma, Italy

IRCCS Azienda Ospedaliera Universitaria San Martino - Genova; 🇮🇹 Genova, Italy

Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute; 🇮🇹 Milano, Italy

Azienda Ospedaliero-Universitaria di Modena; 🇮🇹 Modena, Italy

Istituti Clinici Scientifici Maugeri; 🇮🇹 Montescano, Italy