Validation Study of VIRADIA: A Virtual Reality Diagnostic Platform for the Assessment of Neurological and Cognitive Functions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlation Between Virtual Reality (VR) and Standard Test Scores
研究概览
简要总结
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.
详细描述
The VIRADIA validation study investigates the psychometric properties-validity and reliability-of a Virtual Reality (VR) diagnostic platform designed for neurological and cognitive assessment. The platform includes VR adaptations of nine established clinical tests commonly used in neurology and neuropsychology. These tests evaluate fine motor coordination, gait and balance, processing speed, attention, and executive functioning.
The study follows an observational, within-subjects, paired design. Each participant completes both the standard (paper-based or face-to-face) version and the corresponding VR version of all tests. The order of modalities is counterbalanced across participants to control for order effects. Two groups are enrolled:
- Healthy adults (control group)
- Patients with neurological conditions (clinical group; one priority diagnosis in the first phase)
Objectives
- To evaluate the convergent validity of VR-based test scores compared to standard clinical versions.
- To analyze discriminative validity, i.e., whether VR test results can differentiate between healthy individuals and neurological patients comparably to standard methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Correlation Between Virtual Reality (VR) and Standard Test Scores
时间窗: Single assessment on Day 1 (one testing session)
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.
次要结局
未报告次要终点