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

NCT07268079 | Recruiting

• 1 other identifier: 09I05-03-V04
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neurological Disorders; Cognitive Impairment; Motor Impairment; Neurodegenerative Diseases

Keywords

Virtual Reality; Neurological Diagnostics; Cognitive Assessment; Motor Function; Neuropsychology; Validity; Digital Health

Outcome Measures

Primary Outcomes (1)

• Correlation Between Virtual Reality (VR) and Standard Test Scores

  Convergent validity will be assessed by correlating participants' performance on the VR versions of nine diagnostic tests (9HPT, 25FWT, TUG-M, FRT, SDMT, CDT, TMT-A/B, Stroop, and SATURN) with their corresponding standard (paper or face-to-face) versions.

  Single assessment on Day 1 (one testing session)

Study Arms (2)

Healthy controls

Healthy adult volunteers without known neurological or psychiatric conditions. Participants complete both the standard (paper-based or face-to-face) and Virtual Reality (VR) versions of all diagnostic tests.

Diagnostic Test: VIRADIA - Virtual Reality Diagnostic Platform

Neurological Patients

Adults with a confirmed neurological diagnosis (e.g., Parkinson's disease or related motor/cognitive disorder). Participants complete both the standard and Virtual Reality versions of the diagnostic tests.

Diagnostic Test: VIRADIA - Virtual Reality Diagnostic Platform

Interventions

VIRADIA - Virtual Reality Diagnostic Platform DIAGNOSTIC_TEST

Participants complete a series of diagnostic tests in the VIRADIA virtual reality environment.

Healthy controls; Neurological Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-80 years, including healthy volunteers and patients with neurological diagnoses recruited from outpatient neurology clinics and community sources in Nitra, Slovakia. Participants are screened for eligibility, provide informed consent, and complete both standard and Virtual Reality versions of diagnostic tests.

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.

Sponsors & Collaborators

• Gametherapy: lead

Study Sites (1)

INNER s.r.o., Fatranská 873/12, 94901 Nitra

Nitra, Nitra Region, 94901, Slovakia

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Nervous System Diseases; Cognitive Dysfunction; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ingrid Menkyova, MD, PhD.

  PRINCIPAL INVESTIGATOR

• Martin Polak, Dr.

  Gametherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Polak, Dr.

CONTACT

+421915546098; martin@gametherapy.eu

Andrej Gero, Ing.

CONTACT

+421904111456; andrej@gametherapy.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: May 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)