The goal of this study is determine if a high-tech rehabilitation circuit is more effective than usual rehabilitation methods in improving functional outcome, particularly balance control, for patients with acute neuromuscolar diseases. The main question it aims to answer is:
Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, more effective than traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with acute 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.
Adults with ages ranging from 18 to 80 years.
Patients with a confirmed diagnosis of acute/subacute neuromuscular diseases (e.g. GBS, CIM, CIP)
Time of onset ranging from 15 to 30 days
Patients with lower limb strength (Medical Research Council or MRC) >=2 in at least two of the flexor and extensor muscles of the following joints: hip, knee and ankle
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 or breastfeeding women.
Parallel
High-tech rehabilitative treatment
DeviceRobotic Verticalization System (e.g., Erigo): Assists in regaining upright posture and mobility. 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
Rehabilitation
Other interventionTraditional rehabilitative treatment
Change from baseline in Berg Balance Scale
Improvement in balance measured by the Berg Balance Scale (BBS), with a target improvement of at least 10 points from baseline to the end of the treatment period. BBS is used to objectively determine a patient's ability (or inability) to safely balance during a series of 14 tasks; each task ranks from 0 to 4, with a total score of 56. Higher score indicates the higher level of function.
Change from baseline in Modified Barthel Index
Modified Barthel Index (MBI). The MBI is an adaptation of the original Barthel Index, designed to assess a patient's ability to perform activities of daily living (ADLs) and their level of independence. The MBI evaluates ten specific functions: Feeding, Bathing, Grooming, Dressing, Bowel control, Bladder control, Toileting, Transfers (e.g., bed to chair), Mobility (e.g., walking or wheelchair use), Stair climbing. Each item is scored on a 5-level ordinal scale. Interpretation: 0-20, Total dependency; 21-60, Severe dependency; 61-90, Moderate dependency; 91-99, Slight dependency; 100, Independence
Change from baseline in Trunk Control Test
Trunk Control Test (TCT) for non-ambulatory patients. The TCT is a clinical assessment tool used to evaluate trunk movement control in patients, particularly those who have suffered a stroke or other neurological disorders. The TCT measures four specific movements: 1) Rolling to the weak side: The patient rolls from a supine position to their weaker side; 2) Rolling to the strong side: The patient rolls from a supine position to their stronger side; 3) Balance in a sitting position: The patient sits on the edge of a bed or table without support for at least 30 seconds; 4) Sitting up from lying down: The patient moves from a lying to a sitting position. Each movement is scored on a scale from 0 to 25, with a total possible score of 100. Higher scores indicate better trunk control (Collin \& Wade 1990)
Change from baseline in 2-Minute Walk Test
2-Minute Walk Test (2MWT) for ambulatory patients. 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 or feet is recorded
Change from baseline in Modified Erasmus GBS Outcome Score
Modified Erasmus GBS Outcome Score (mEGOS) for Guillain-Barrè Syndrome patients: is a clinical prediction model used to estimate the likelihood of a patient with GBS being unable to walk independently six months after disease onset. This score is calculated based on three key factors: 1) Age at onset of neurological symptoms; 2) Preceding diarrhea before the onset of symptoms; 3) Severity of muscle weakness, assessed using the Medical Research Council sum score. The mEGOS provides a score ranging from 0 to 12, with higher scores indicating a higher risk of walking inability
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.
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Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Azienda Ospedaliero-Universitaria di Modena
Collaborator
Fondazione Don Carlo Gnocchi ETS
Collaborator
Ospedale Policlinico San Martino
Collaborator
