Validation of the VIRADIA App for Neurological and Cognitive Diagnostics in Virtual Reality

The VIRADIA study aims to validate and assess the reliability of a newly developed Virtual Reality (VR) diagnostic platform designed for neurological and cognitive testing. The goal is to determine whether the VR versions of nine commonly used clinical tests measure the same constructs and provide comparable results to their traditional face-to-face or paper-based forms. The study includes two groups of participants: (1) healthy volunteers and (2) patients with neurological diagnoses. Each participant will complete both the standard and the VR versions of the tests, with the order of administration randomly assigned. The tested functions cover fine motor skills, gait and balance, attention, executive function, processing speed, and visuospatial abilities. The following tests are included in the VR platform: 9-Hole Peg Test (9HPT), 6 Meter Walk Test, Timed Up and Go - Manual (TUG-M), Functional Reach Test (FRT), Symbol Digit Modalities Test (SDMT), Clock Drawing Test (CDT), Trail Making Test (TMT A/B), Stroop Test, and SATURN Test. Participants will first provide informed consent and basic demographic information. They will then complete all tests in both modalities (standard and VR), with appropriate breaks between tasks. The study is observational, within-subjects, and paired in design. Primary outcomes include correlation and agreement between VR and standard test scores (validity). Data will be analyzed using paired statistical methods, including Pearson/Spearman correlations, Bland-Altman analysis, and Intraclass Correlation Coefficients (ICC). No medication or invasive intervention is used in this study. The VR testing is non-invasive and carries minimal risk. The study has been approved by the Ethics Committee of the Nitra Self-Governing Region (Approval No. 09I05-03-804). The results will provide evidence for the validity and reliability of VR-based diagnostics and support the use of the VIRADIA platform as a safe, standardized tool for neurological and cognitive assessment.

NCT Number	NCT07268079
Lead Sponsor	Gametherapy
Conditions	Neurological Disorders, Cognitive Impairment, Motor Impairment, Neurodegenerative Diseases
Enrollment	200 participants
Start Date	2025-12-01
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-05