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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.

Study acronym: 3DOF
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 6, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study Status, Eligibilityv2
  2. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07502937
Lead Sponsor University of Pavia
Collaborators: Istituti Clinici Scientifici Maugeri SpA
Conditions
(from sponsor)
Neurological Disorders, Health Adult Subjects
Related terms Nervous System Diseases
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov