Validation Study of VIRADIA: A Virtual Reality Diagnostic Platform for the Assessment of Neurological and Cognitive Functions
Conditions: Neurological Disorders, Cognitive Impairment, Motor Impairment, Neurodegenerative Diseases
Sponsor: Gametherapy

 
 
 
 
 
 
 
Study Protocol and Statistical Analysis Plan 
 
Validation Study of VIRADIA: A Virtual Reality Diagnostic Platform for the 
Assessment of Neurological and Cognitive Functions 
Protocol ID: 09I05-03-804 
NCT Number: - 
Document Date: December 03, 2025 
Sponsor: GAMETHERAPY s.r.o. 
Study Site: INNER s.r.o., Fatranská 873/12, 94901 Nitra, Slovakia 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose 
 
The study aims to validate and assess the reliability of the VIRADIA Virtual Reality (VR) 
diagnostic platform designed for neurological and cognitive testing. The goal is to 
determine whether VR versions of nine standardized diagnostic tests measure the same 
constructs and provide comparable results to their traditional forms. 
Study Design 
 
Within-subjects, paired protocol. Each participant completes both the standard and VR 
versions of all tests. Order of administration is counterbalanced. Participants include 
healthy volunteers and patients with neurological diagnoses. 
Tests Included 
 
1. 9-Hole Peg Test (9HPT) 2. 6 Meter Walk Test (6MWT) 3. Timed Up and Go – Manual 
(TUG-M) 4. Functional Reach Test (FRT) 5. Symbol Digit Modalities Test (SDMT) 6. Clock 
Drawing Test (CDT) 7. Trail Making Test (TMT A/B) 8. Stroop Test 9. SATURN Test 
Procedures 
 
Participants provide informed consent and demographic data. Each completes both 
standard and VR tests in randomized order. A short post-assessment questionnaire 
evaluates tolerability of VR exposure. 
Sample Size and Power 
 
Target N ≈ 200 participants (100 healthy, 100 patients). Power analysis was based on 
paired ROC/AUC comparison (AUC  0.75, AUC  0.05,  = 0.05, power = 0.90). 15% 
added to account for attrition and unusable data. 
Timeline and Logistics 
 
Each participant session lasts ~60 minutes. Various parallel testing stations allow ~4 
participants per day. Total data collection time  50 working days for full sample. 
Roles and Responsibilities 
 
Principal Investigator: study supervision and report approval. Neurological Expert: clinical 
oversight and task safety. Study Coordinator: recruitment, scheduling, and QA. 
Administrators: conduct testing. Data Analyst: data cleaning, statistical analysis, and report 
generation. 
Statistical Analysis Plan 
 
Primary analyses: Pearson/Spearman correlations for convergent validity between VR and 
standard scores. Agreement analysis via Bland–Altman (bias, 95% limits of agreement). 
Discriminative validity through ROC/AUC (DeLong) between groups. All analyses performed 
with 95% confidence intervals. 
Ethics and Safety 
 
The study involves non-invasive diagnostic testing with minimal risk. All participants 
provide informed consent. Approved by the Ethics Committee of the Nitra Self-Governing 
Region (Approval No. 09I05-03-804).