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

Recruiting now

Conditions studied: Neurological Disorders, Cognitive Impairment, Motor Impairment, Neurodegenerative Diseases

In brief

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.

Key facts

Study ID: NCT07268079
Run by: Gametherapy
People needed: 200
Starts: 2025-12-01
Expected to finish: 2026-05-01
Last updated by the study team: 2025-12-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age 18-80 years.
Ability to provide informed consent.
Adequate vision and hearing to complete testing.
For the neurological group: confirmed diagnosis of a neurological disorder (e.g., Parkinson's disease, multiple sclerosis, or similar).
For the control group: no history of neurological or psychiatric disease.

You may not qualify if…

Severe cognitive impairment (MMSE < 24 or equivalent clinical judgment).
Acute neurological or psychiatric condition interfering with testing.
Severe motor disability preventing task performance (e.g., inability to use VR controller).
Current substance abuse.
Uncorrected visual impairment or vestibular disorder leading to intolerance of VR.

Where it is running

INNER s.r.o., Fatranská 873/12, 94901 Nitra — Nitra, Nitra Region, Slovakia (enrolling)

Full record on ClinicalTrials.gov

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