This multicenter interventional study aims to evaluate a three-degrees-of-freedom dynamic platform (3DoF Platform) designed to support rehabilitation of balance, proprioception, and motor and cognitive functions in patients with neurological disorders. The device integrates a mobile platform capable of roll, pitch, and vertical translation movements, a markerless motion-capture system, and an interactive environment delivered through a monitor or virtual reality headset. Compared with conventional rehabilitation systems, it offers an additional vertical degree of freedom and increased proprioceptive stimulation, with the ability to customize exercises according to individual patient capabilities. The clinical conditions under investigation include Parkinson's disease, post-stroke motor impairment, amyotrophic lateral sclerosis, and mild cognitive impairment, all of which are associated with deficits in balance and proprioception. The novelty of this study lies in the combined use of the 3DoF platform, the markerless acquisition system, and exergames integrated with a mathematical model that adapts the platform's dynamic response in real time. The primary objective is to assess the usability, feasibility, and safety of the device. Secondary objectives include evaluating the impact of the intervention on balance, motor performance, cognitive functions, stress, fatigue, and quality of life, as well as comparing conventional rehabilitation with and without the addition of the device. The study involves 45 patients and 15 healthy volunteers and is structured into an initial phase of testing on healthy subjects and a subsequent randomized two-arm treatment phase for patients.
Patients: adults aged 18 to 80 years.
Patients: confirmed diagnosis of one of the following chronic neurological conditions: stroke, Parkinson's disease, amyotrophic lateral sclerosis (ALS), or mild cognitive impairment (MCI).
Patients: able to understand and follow study procedures and provide informed consent.
Healthy volunteers: adults aged 18 to 65 years.
Patients: severe psychiatric disorders or cognitive disorders that impair the ability to complete cognitive tests and self-report questionnaires.
Patients: unable to provide informed consent.
Patients: moderate to severe cognitive impairment, defined as an ECAS score below 81.92 in participants with ALS or a Raven's Matrices score below 18.36 in participants with mild cognitive impairment.
Patients: neurological or physical conditions that significantly limit lower-limb use and prevent standing on the platform, including lower-limb muscle strength of 3 or less on the Medical Research Council (MRC) scale.
Parallel
3DOF balance board robotic platform group
DeviceThe 3DOF balance platform system distinguishes itself by providing controlled perturbations across three degrees of freedom: roll, pitch, and vertical translation (heave), the latter being a unique feature for enhancing proprioceptive stimulation. The platform integrates a markerless motion capture system that tracks the patient's Center of Mass in real-time without wearable sensors.
Conventional Rehabilitation
Other interventionTraditional rehabilitative treatment delivered according to usual clinical practice at the participating centers. Participants undergo 12 sessions of at least 30 minutes each, three times per week.
Incidence of Adverse Events
Safety of the 3DoF platform for participants and operators will be assessed by recording the incidence and frequency of adverse events reported by the participant or observed by the operator during each study session. Adverse events include, for example, falls or episodes of instability during platform use, post-exercise musculoskeletal pain, technical malfunctions of the platform, dizziness or nausea related to vestibular stimulation or virtual reality, and premature interruption of the session by the participant or therapist.
Evaluation of System Usability Scale (SUS)
SUS consists of a series of 10 questions, which users answer using a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." The questions are designed to assess various aspects of usability, such as ease of use, complexity and user satisfaction. Total score ranges from 0 to 100, with higher scores indicating better usability.
Evaluation of Quality of Care Through the Patient's Eyes (QUEST) 2.0
This QUEST 2.0 questionnaire is used to assess patient satisfaction with healthcare services. "QUEST" stands for "Quality of Care Through the Patient's Eyes" and was developed to measure patients' perceptions of the quality of healthcare services and support. Version 2.0 is an update of the original questionnaire designed to make it more comprehensive and suitable for various healthcare settings. Reported as total questionnaire score; higher scores indicate greater satisfaction with the device and related services.
Evaluation of 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. Reported as total questionnaire score; higher scores indicate a more positive perception of technology-assisted rehabilitation.
Change from baseline in Berg Balance Scale
Change in balance performance assessed with the Berg Balance Scale (BBS). The BBS evaluates balance and stability across 14 tasks. . Total score ranges from 0 to 56, with higher scores indicating better balance performance.
Change From Baseline in Timed Up and Go (TUG)
Change in mobility and balance assessed with the Timed Up and Go (TUG) test, defined as the time required to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Lower values indicate better performance.
Change From Baseline in 6-Minute Walk Test (6MWT)
Change in functional walking capacity assessed with the 6-Minute Walk Test (6MWT), defined as the distance walked in 6 minutes. Higher values indicate better performance.
Change From Baseline in 10-Meter Walk Test (10MWT)
Change in gait performance assessed with the 10-Meter Walk Test (10MWT), used to evaluate walking speed over 10 meters. Higher values indicate better performance. Time Frame:
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University of Pavia
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
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