Cognitive Rehabilitation With Virtual Reality in Parkinson Disease

ConditionsParkinson Desease Mild Cognitive Impairment (MCI)

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Cognitive Training with PRoBio in Parkinson's DiseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

Week 4 (post-treatment, T1)

Secondary outcomes

Session Attendance and Treatment Adherence

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.

Time frame

Weeks 1-4

Response Accuracy in Cognitive Tasks (VRRS Software)

Accuracy rate in exercises performed during each session, as recorded by VRRS.

Time frame

Weeks 1-4

Reaction Times in Cognitive Tasks (VRRS Software)

Mean reaction times (ms) recorded during cognitive tasks using the PRoBio platform.

Time frame

Weeks 1-4

Movement Amplitude (RGB-D Camera Analysis)

Mean amplitude of upper limb movements captured via RGB-D camera.

Time frame

Weeks 1-4

Other outcomes

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

PD-CRS scores will be collected to evaluate changes in cognitive performance. Scores range from 0 to 134; higher scores indicate better cognition.

Time frame

Baseline (T0) and Week 4 (T1)

Executive Function - Stroop Color Word Test (SCWT)

Performance on SCWT will be measured by response times and error rate.

Time frame

Baseline (T0) and Week 4 (T1)

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

Completion time (in seconds) for TMT-A and TMT-B will be recorded.

Time frame

Baseline (T0) and Week 4 (T1)

Quality of Life - Parkinson's Disease Questionnaire (PDQ-39)

Quality of life will be measured through the PDQ-39. Scores range from 0 to 100; lower scores indicate better quality of life.

Time frame

Baseline (T0) and Week 4 (T1)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Università Campus Bio-Medico di Roma (UCBM)

Collaborator

Khymeia Group S.r.l.

Collaborator

Source ClinicalTrials.gov

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