Protocol for a Three-Arm Pilot Randomized Controlled Trial of Immersive Virtual Reality Versus Content-Matched Tablet Rehabilitation for Post-Intensive Care Syndrome

Abstract

Between 50% and 75% of intensive care unit (ICU) survivors develop post-intensive care syndrome (PICS), a cluster of physical, cognitive, and psychological impairments that reduce quality of life. Virtual reality (VR) has emerged as a candidate rehabilitation technology, but studies rarely compare immersive VR with non-immersive digital tools to isolate the exact contribution of immersion. This study evaluates the feasibility, acceptability, and safety of immersive VR and generates preliminary effect-size estimates on cognitive recovery, comparing it to a content-matched tablet intervention and usual care. This prospective, three-arm, parallel-group pilot randomized controlled trial is conducted in a university hospital ICU and following wards. Critically ill adults are allocated 1:1:1 to VR rehabilitation (VR-Rehab), content-matched tablet rehabilitation (Tablet-Rehab), or standard of care (SOC). The intervention consists of a once-daily 12-minute session of six matched cognitive and motor game pairs, delivered for up to seven days or until discharge. Both active arms feature identical therapeutic content, task logic, and dose, varying only the delivery medium. The recruitment target is 51 participants (17 per arm), consistent with pilot trial guidance. The primary outcome is global cognitive function. Secondary outcomes include clinical metrics (physical function, psychological distress, health-related quality of life) and digital game metrics (in-game biomarkers, delivery feasibility, safety, and usability). All outcomes are assessed at baseline, post-intervention, and follow-up. As a study protocol, this article reports the trial design, intervention, and pre-specified analysis plan in accordance with SPIRIT guidance; no outcome results are presented.