About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 3DOF balance board robotic platform group
- Conventional Rehabilitation
Treatment groups
Locations
Sponsors and collaborators
University of Pavia
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator