A Multicenter Interventional Study on the Use of a 3-Degree-of-Freedom (3DOF) Platform to Evaluate the Safety and Usability of the System and Its Impact on Balance, Proprioception, and Neurological Deficits in the Rehabilitation of Patients With Neurological Disorders.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Pavia

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

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Pavia

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborator