Cognitive Rehabilitation With Virtual Reality in Parkinson Disease

NCT06920511 | Not Yet Recruiting

• 2 other identifiers: OperaPNRR - AGE-IT SPOKE 1 e SPOKE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Desease; Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (5)

• System Usability Scale (SUS) - Patient Reported Outcome

  Assessment of system usability using the 10-item SUS scale. Scores range from 0 to 100; higher scores indicate better usability.

  Week 4 (post-treatment, T1)

• eHealth Usability Benchmarking Instrument (HUBBI)

  Assessment of system usability using the HUBBI questionnaire. Items rated on a 7-point scale; higher scores indicate better usability.

  Week 4 (post-treatment, T1)

• User Experience Questionnaire - Short Version (UEQ-S)

  Evaluation of pragmatic and hedonic user experience with the UEQ-S. Each item rated from -3 to +3; higher scores indicate more positive experience.

  Week 4 (post-treatment, T1)

• Technology Acceptance Model (TAM) and UTAUT Scores

  Evaluation of perceived usefulness and ease of use via TAM and UTAUT scales. Items rated on 5-point Likert scales.

  Week 4 (post-treatment, T1)

• NASA Task Load Index (NASA-TLX)

  Evaluation of cognitive workload using the NASA-TLX scale. Scores range from 0 to 100; higher scores indicate higher workload.

  Week 4 (post-treatment, T1)

Secondary Outcomes (8)

• Session Attendance and Treatment Adherence

  Weeks 1-4

• Response Accuracy in Cognitive Tasks (VRRS Software)

  Weeks 1-4

• Reaction Times in Cognitive Tasks (VRRS Software)

  Weeks 1-4

• Movement Amplitude (RGB-D Camera Analysis)

  Weeks 1-4

• Movement Velocity (RGB-D Camera Analysis)

  Weeks 1-4

Other Outcomes (6)

• Cognitive Function - Parkinson's Disease Cognitive Rating Scale (PD-CRS)

  Baseline (T0) and Week 4 (T1)

• Executive Function - Stroop Color Word Test (SCWT)

  Baseline (T0) and Week 4 (T1)

• Cognitive Flexibility - Trail Making Test (TMT A & B)

  Baseline (T0) and Week 4 (T1)

Study Arms (1)

Cognitive Training with PRoBio in Parkinson's Disease

EXPERIMENTAL

Patients with Parkinson's Disease and Mild Cognitive Impairment will undergo a cognitive rehabilitation program using the PRoBio robotic platform. The intervention consists of 3 sessions per week (45 minutes each) for 4 weeks. The PRoBio system includes virtual reality exercises and real-time feedback based on motor and emotional responses.

Device: Cognitve rehabilitation with virtual reality and robotic arm

Interventions

Cognitve rehabilitation with virtual reality and robotic arm DEVICE

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.

Also known as: TIAGo, COMPACT VRRS, Robotic Bio-Cooperative Training, Virtual Reality Rehabilitation with PRoBio, PRoBio platform

Cognitive Training with PRoBio in Parkinson's Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Università Campus Bio-Medico di Roma (UCBM): collaborator
• Khymeia Group S.r.l.: collaborator

Study Sites (1)

Fondazione Don Gnocchi

Sant'Angelo dei Lombardi, Avellino, 83054, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anna Estraneo, MD

  Fondazione Don Gnocchi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Estraneo, MD

CONTACT

+39 339 6418648; aestraneo@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD- Responsabile della Sperimentazione

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 9, 2025
• Study Start: May 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: Access will be granted to qualified researchers affiliated with academic or clinical institutions, for the purpose of secondary analyses, meta-analyses, or method development. Requests must be submitted in writing to the principal investigator and will be evaluated by the study team. Data will be shared via secure file transfer methods upon approval.

Locations

IT (1)