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.
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
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.
Parallel
High-tech rehabilitative treatment
DeviceVirtual 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
Rehabilitation
Other interventionTraditional rehabilitative treatment
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).
Change from baseline in Time Up and Go Test
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
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)
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
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 Insulin Growth Factor 1 and free Insulin Growth Factor 1
Will be measured these biomarkers in order to assess the levels changes during the treatment. Serum level will be measured in nanogram/milliliter
Change from baseline in Neurofilament-Light chain
Will be measured this biomarker in order to assess the levels changes during the treatment. Plasma level will be measured in picogram/milliliter.
Change from baseline in Sarcopenia level
Sarcopenia level will be measured through two different analysis. One of this analysis is the assessment of Appendicular Skeletal Muscle Mass (ASMM). ASMM is measured using bioelectrical impedance analysis (BIA) devices, which assess body composition by analyzing the electrical resistance of body tissues. A low ASMM is a key indicator of sarcopenia, the age-related loss of muscle mass. ASMM is measured in kilograms.
Change from baseline in Sarcopenia level
The other analysis used to assess the level of sarcopenia will be the measurement of Temporal Muscle Thickness (TMT) using ultrasound imaging. Craniofacial muscle mass has been identified as a reliable indicator for detecting sarcopenia, in addition to thoracolumbar skeletal muscle mass. Ultrasound imaging is performed on the temporal muscle to measure parameters such as muscle thickness (measurement of the musclular depth from the skin surface) and cross-sectional area (area of the muscle in a specific plane, indicating muscle mass).
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Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Ospedale Policlinico San Martino
Collaborator
Azienda Ospedaliero-Universitaria di Modena
Collaborator
Fondazione Don Carlo Gnocchi ETS
Collaborator
