Cognitive Rehabilitation With Virtual Reality in Parkinson Disease

Summary

The OPERA Clinical Study is an interventional, single-arm, open-label pilot clinical study that aims to evaluate the usability of an innovative bio-cooperative robotic platform (PRoBio) for cognitive rehabilitation in patients with Parkinson's Disease (PD) and Mild Cognitive Impairment (MCI). The study focuses on assessing the effectiveness and acceptability of the system in a pilot study involving patients undergoing a structured cognitive rehabilitation program.

PRoBio is an advanced rehabilitation platform that integrates the TIAGo robotic system, developed by PAL Robotics, with the VRRS COMPACT virtual reality rehabilitation system, designed by Khymeia. TIAGo is provided by a robotic arm and RGB-D camera that allow the collection of biomechanical and psychophysiological data, which are then used to personalize the treatment through the cognitive tasks provided by the VRRS COMPACT. The pilot study involves patients with PD-MCI, who will undergo a four-week rehabilitation program with ProBio, consisting of three weekly sessions of virtual cognitive training. The primary objective is to assess the usability and compliance of the system by evaluating user experience, ease of interaction, and engagement levels among both patients and rehabilitation professionals, as well as evaluating its ability to monitor biomechanical and psychophysiological parameters during treatment. This assessment will be conducted using a multimodal sensor system, which includes an RGB-D camera integrated into the UCBM TIAGo robot and wearable sensors designed to measure heart rate, respiratory rate, and galvanic skin response. The data collected through these sensors will be analyzed offline to personalize cognitive rehabilitation treatments in subsequent sessions. Additionally, the study aims to evaluate the accuracy and response times of patients while performing cognitive exercises, as recorded by the VRRS system. Furthermore, the study will explore the potential effects of PRoBio treatment on the cognitive functions of patients with Parkinson's Disease and Mild Cognitive Impairment (PD-MCI) as a possible future rehabilitation to include in the clinical practice.

Conditions

• Parkinson Desease
• Mild Cognitive Impairment (MCI)

Interventions

DEVICE

Cognitve rehabilitation with virtual reality and robotic arm

The intervention consists of a cognitive rehabilitation program using the PRoBio platform, a bio-cooperative robotic system integrating virtual reality and real-time multisensory feedback. The PRoBio platform includes a robotic arm (TIAGo), a virtual reality interface (VRRS), and sensors to monitor biomechanical, cognitive, and emotional parameters during training.

Sponsors & Collaborators

• Università Campus Bio-Medico di Roma (UCBM)

  collaborator UNKNOWN

• Khymeia Group S.r.l.

  collaborator UNKNOWN

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Principal Investigators

• Anna Estraneo, MD · Fondazione Don Gnocchi

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2025-07-31

Completion

2025-07-31

Countries

• Italy

Study Locations