Actively Recruiting
Validation of the VIRADIA App for Neurological and Cognitive Diagnostics in Virtual Reality
Led by Gametherapy · Updated on 2025-12-05
200
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validation of the VIRADIA App for Neurological and Cognitive Diagnostics in Virtual Reality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years
- Ability to provide informed consent
- Adequate vision and hearing to complete testing
- For neurological group: confirmed diagnosis of a neurological disorder such as Parkinson's disease or multiple sclerosis
- For control group: no history of neurological or psychiatric disease
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
INNER s.r.o., Fatranská 873/12, 94901 Nitra
Nitra, Nitra Region, Slovakia, 94901
Actively Recruiting
Research Team
M
Martin Polak, Dr.
CONTACT
A
Andrej Gero, Ing.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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