Cognitive Rehabilitation With Virtual Reality in Parkinson Disease

Not Applicable

Not yet recruiting

• Conditions: Parkinson Desease; Mild Cognitive Impairment (MCI)

• Registration Number: NCT06920511
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief 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.

Detailed Description

The pilot study will be conducted at two clinical centers, the Fondazione Don Carlo Gnocchi ONLUS sites in Sant'Angelo dei Lombardi (AV) and Florence (FI).

The first step involves obtaining informed consent from all participants. Following this, a baseline assessment (T0) will be carried out, including the collection of demographic and anamnesis data, as well as cognitive and psychological evaluations. These assessments will help confirm eligibility criteria and serve as a pre-treatment evaluation for enrolled patients. The assessment tools include the MDS-Unified Parkinson's Disease Rating Scale, the Parkinson's Disease Cognitive Rating Scale, the Stroop Color Word Test, the Trail Making Test (A and B), the Parkinson's Disease Questionnaire (PDQ-39), the 15-item Geriatric Depression Scale, and the Geriatric Anxiety Inventory.

Once baseline evaluations are completed, patients will begin a structured cognitive rehabilitation program using the ProBio platform, which integrates the UCBM TIAGo service robot with the VRRS COMPACT telerehabilitation system developed by Khymeia. The rehabilitation program will consist of three weekly sessions, each lasting 45 minutes, for a total duration of four weeks. The cognitive tasks and activities will be tailored to the individual patient's abilities to provide a personalized treatment plan aimed at improving specific cognitive functions. During the rehabilitation sessions, UCBM TIAGo will continuously monitor the patient's physical and emotional state, collecting data through advanced sensors and its integrated RGB-D camera. These data will be analyzed offline to adjust the complexity and intensity of exercises for subsequent sessions based on individual responses.

Throughout the treatment, several parameters will be recorded. The accuracy and response times in cognitive exercises will be documented in reports generated by the VRRS software. Biomechanical parameters, such as movement amplitude and speed, will be measured using the RGB-D camera, while psychophysiological parameters, including respiratory rate, heart rate, and skin conductance, will be monitored via wearable sensors. Based on these parameters, the VRRS system will provide real-time visual and vocal feedback to the patient regarding response accuracy and exercise execution. Additionally, at the end of each session, the bio-cooperative robot TIAGo will verbally interact with the patient to assess their experience, including perceived enjoyment, task comprehension, and ease of execution.

At the end of the four-week rehabilitation program, a final evaluation (T1) will be conducted using the same cognitive and psychological assessment tools applied at baseline. This will include the MDS-Unified Parkinson's Disease Rating Scale, the Parkinson's Disease Cognitive Rating Scale, the Stroop Color Word Test, the Trail Making Test, the Parkinson's Disease Questionnaire (PDQ-39), the 15-item Geriatric Depression Scale, and the Geriatric Anxiety Inventory. The study also aims to explore the potential of integrating robotic bio-cooperative platforms into routine clinical rehabilitation settings, providing insights into their feasibility and effectiveness for future large-scale applications.

Study Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-05-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• Diagnosis of Parkinson's Disease Dementia, atypical parkinsonisms, secondary parkinsonisms, or mixed forms;
• Severe depressive syndrome
• Absence of signed informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
System Usability Scale (SUS) - Patient Reported Outcome	Week 4 (post-treatment, T1)	Assessment of system usability using the 10-item SUS scale. Scores range from 0 to 100; higher scores indicate better usability.
eHealth Usability Benchmarking Instrument (HUBBI)	Week 4 (post-treatment, T1)	Assessment of system usability using the HUBBI questionnaire. Items rated on a 7-point scale; higher scores indicate better usability.
User Experience Questionnaire - Short Version (UEQ-S)	Week 4 (post-treatment, T1)	Evaluation of pragmatic and hedonic user experience with the UEQ-S. Each item rated from -3 to +3; higher scores indicate more positive experience.
Technology Acceptance Model (TAM) and UTAUT Scores	Week 4 (post-treatment, T1)	Evaluation of perceived usefulness and ease of use via TAM and UTAUT scales. Items rated on 5-point Likert scales.
NASA Task Load Index (NASA-TLX)	Week 4 (post-treatment, T1)	Evaluation of cognitive workload using the NASA-TLX scale. Scores range from 0 to 100; higher scores indicate higher workload.

Secondary Outcome Measures

Name	Time	Method
Session Attendance and Treatment Adherence	Weeks 1-4	Evaluation of the acceptance of the PRoBio platform by patients and clinicians, based on session attendance, treatment adherence, and system usability for operators. Additionally, the ability of PRoBio to collect biomechanical and psychophysiological data during treatment will be assessed. These include response accuracy and reaction times (collected by VRRS), movement amplitude and velocity (via RGB-D camera), and physiological indicators (heart rate, respiratory rate, and skin conductance) recorded through wearable sensors. These data will be used offline to customize the rehabilitation sessions.
Response Accuracy in Cognitive Tasks (VRRS Software)	Weeks 1-4	Accuracy rate in exercises performed during each session, as recorded by VRRS.
Reaction Times in Cognitive Tasks (VRRS Software)	Weeks 1-4	Mean reaction times (ms) recorded during cognitive tasks using the PRoBio platform.
Movement Amplitude (RGB-D Camera Analysis)	Weeks 1-4	Mean amplitude of upper limb movements captured via RGB-D camera.
Movement Velocity (RGB-D Camera Analysis)	Weeks 1-4	Mean velocity of arm movements during tasks, as measured by RGB-D camera.
Heart Rate During Sessions (Wearable Sensors)	Weeks 1-4	Average heart rate recorded during rehabilitation sessions.
Respiratory Rate During Sessions (Wearable Sensors)	Weeks 1-4	Average respiratory rate recorded during sessions.
Skin Conductance Level (SCL) During Sessions	Weeks 1-4	Average SCL value measured by wearable sensors as indicator of emotional arousal.

Trial Locations

Locations (1)

Fondazione Don Gnocchi; 🇮🇹 Sant'Angelo dei Lombardi, Avellino, Italy