Cognitive Rehabilitation With Virtual Reality in Parkinson Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosis of mild Parkinson's Disease (Hoehn & Yahr stage II-III);

Diagnosis of Mild Cognitive Impairment (MCI) according to Litvan et al. (2012) criteria for PD-MCI;

Age ≥ 18 years;

Signed informed consent

Disqualifiers

Diagnosis of Parkinson's Disease Dementia, atypical parkinsonisms, secondary parkinsonisms, or mixed forms;

Severe depressive syndrome

Absence of signed informed consent

Trial design

Treatments tested in this trial

  • Cognitve rehabilitation with virtual reality and robotic arm

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Università Campus Bio-Medico di Roma (UCBM)

Collaborator

Khymeia Group S.r.l.

Collaborator