Currently submitted to: JMIR Serious Games
Date Submitted: Sep 12, 2026
Open Peer Review Period: Sep 13, 2026 - Oct 9, 2026
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Neuroengineering Design Associated with Low Virtual Reality Sickness Incidence in Clinical Rehabilitation: A Large-Scale Real-World Feasibility and Safety Study
ABSTRACT
Background:
Virtual reality (VR) sickness is a significant barrier to the clinical adoption of immersive rehabilitation. Incidence rates of 20% to 80% are frequently reported in consumer-grade VR, though largely under dynamic, locomotion-based conditions; engineering solutions specifically optimized for static, clinical use remain under-evaluated at scale.
Objective:
This study aims to investigate, as a real-world feasibility and safety study, the incidence of VR sickness associated with a purpose-built VR medical device utilizing seven integrated engineering principles in diverse clinical and real-world settings.
Methods:
This retrospective observational study analyzed two cohorts: (1) a primary cohort of 3,572 unique users between 2023 and 2025 ; and (2) a large-scale post-marketing surveillance (PMS) dataset encompassing 337,577 therapeutic sessions across 170 medical institutions. The evaluated system incorporates multisensory design principles, including static visual backgrounds, enhanced somatosensory input, and predictive spatial mapping, to minimize sensory conflict. The primary outcome was the incidence of VR-induced sickness (nausea, dizziness, or malaise). Secondary outcomes included serious adverse events such as falls or injuries.
Results:
In the primary cohort (age range, 3–100 years), the incidence of VR sickness was 0.36% (95% confidence intervals 0.21–0.62%), with only one user (0.03%, 0.01–0.16%) discontinuing the session. In the PMS dataset, there were zero (exact 95% upper bound, 0.00089%) reported incidents of serious adverse events or VR sickness requiring medical intervention across 337,577 sessions.
Conclusions:
A VR system designed with specific multisensory engineering principles was associated with an exceptionally low incidence of VR sickness and a favorable real-world safety profile. These findings provide proof-of-concept evidence that VR sickness incidence can be substantially minimized through systematic engineering design, supporting further investigation of immersive digital therapeutics in routine clinical practice. Clinical Trial: UMIN CTR: UMIN000056624
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