Clinical trial NCT06920511: Cognitive Rehabilitation With Virtual Reality in Parkinson Disease
Official title: Integrated biO-cooPErative Robotic plAtform for Virtual Cognitive-motor Training in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Desease
Mild Cognitive Impairment (MCI)
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Università Campus Bio-Medico di Roma (UCBM)
name: Khymeia Group S.r.l.
First posted: 2025-04-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The OPERA study is designed as a single-group interventional study. All participants are enrolled into one group and receive the same intervention, a cognitive rehabilitation program using the PRoBio platform. There are no comparison groups.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: System Usability Scale (SUS) - Patient Reported Outcome
timeFrame: Week 4 (post-treatment, T1)
measure: eHealth Usability Benchmarking Instrument (HUBBI)
timeFrame: Week 4 (post-treatment, T1)
measure: User Experience Questionnaire - Short Version (UEQ-S)
timeFrame: Week 4 (post-treatment, T1)
measure: Technology Acceptance Model (TAM) and UTAUT Scores
timeFrame: Week 4 (post-treatment, T1)
measure: NASA Task Load Index (NASA-TLX)
timeFrame: Week 4 (post-treatment, T1)
Secondary outcomes:
measure: Session Attendance and Treatment Adherence
timeFrame: Weeks 1-4
measure: Response Accuracy in Cognitive Tasks (VRRS Software)
timeFrame: Weeks 1-4
measure: Reaction Times in Cognitive Tasks (VRRS Software)
timeFrame: Weeks 1-4
measure: Movement Amplitude (RGB-D Camera Analysis)
timeFrame: Weeks 1-4
measure: Movement Velocity (RGB-D Camera Analysis)
timeFrame: Weeks 1-4
measure: Heart Rate During Sessions (Wearable Sensors)
timeFrame: Weeks 1-4
measure: Respiratory Rate During Sessions (Wearable Sensors)
timeFrame: Weeks 1-4
measure: Skin Conductance Level (SCL) During Sessions
timeFrame: Weeks 1-4
Other outcomes:
measure: Cognitive Function - Parkinson's Disease Cognitive Rating Scale (PD-CRS)
timeFrame: Baseline (T0) and Week 4 (T1)
measure: Executive Function - Stroop Color Word Test (SCWT)
timeFrame: Baseline (T0) and Week 4 (T1)
measure: Cognitive Flexibility - Trail Making Test (TMT A & B)
timeFrame: Baseline (T0) and Week 4 (T1)
measure: Quality of Life - Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline (T0) and Week 4 (T1)
measure: Mood - Geriatric Depression Scale (GDS-15)
timeFrame: Baseline (T0) and Week 4 (T1)
measure: Anxiety - Geriatric Anxiety Inventory (GAI)
timeFrame: Baseline (T0) and Week 4 (T1)
Locations:
city: Sant'Angelo dei Lombardi
country: Italy
facility: Fondazione Don Gnocchi
state: Avellino
Study officials:
affiliation: Fondazione Don Gnocchi
name: Anna Estraneo, MD
role: PRINCIPAL_INVESTIGATOR
References: