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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.

NCT07502937 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

3DOF balance board robotic platform group

The 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.

OTHER

Conventional Rehabilitation

Traditional 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.

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    collaborator OTHER

  • University of Pavia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-09-30
Completion
2026-11-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07502937 on ClinicalTrials.gov