Immersive virtual reality for cognitive rehabilitation in patients who had a stroke: study protocol for a randomised controlled trial.

INTRODUCTION: Poststroke cognitive impairment (PSCI) is a prevalent complication of stroke, characterised by deficits in one or more cognitive domains (eg, memory, attention, executive function). Beyond increasing mortality and disability risks, PSCI frequently co-occurs with motor dysfunction, which impairs activities of daily living and reduces quality of life. Due to the complexity of neural networks involved in PSCI, clinical practice currently lacks targeted therapeutic strategies; existing interventions (eg, pharmacotherapy, traditional cognitive training) are limited in scope and variable in efficacy. Here, we developed an innovative dynamic cognitive training system integrated with virtual reality (VR) technology, based on principles of neuroplasticity and multisensory integration. This study aimed to explore the intervention effects of this system on cognitive function in patients with PSCI while incorporating exploratory neuroimaging assessments to provide descriptive and hypothesis-generating information regarding brain functional changes associated with the intervention. METHODS AND ANALYSIS: This single-centre, randomised controlled, evaluator-blinded clinical trial will assess the rehabilitative efficacy of VR-based cognitive training in patients with PSCI. A total of 60 patients who had a stroke will be enrolled and randomised to either a conventional rehabilitation group or a VR intervention group. The intervention will last 2 weeks, with five sessions of 60 min each training session per week. During the 60-minute training session, both groups will receive 30 min of conventional rehabilitation training. For the remaining 30 min, the control group will undergo traditional cognitive rehabilitation while the experimental group will be subjected to VR-based cognitive rehabilitation training. The primary outcome measure is the Montreal Cognitive Assessment; secondary outcomes include the Mini-Mental State Examination, Trail Making Test and Stroop Test. Assessments will be conducted at three time points: baseline (T0), immediately postintervention (T1) and 4 weeks after completing the intervention (T2). This study aims to evaluate the preliminary effectiveness of a VR-based intervention in improving multidimensional cognitive function, while incorporating exploratory neuroimaging outcomes to generate hypothesis-forming insights into potential neural correlates. ETHICS AND DISSEMINATION: The trial was approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (2025-1933-273-02).The results will be submitted to a peer review journal or at a conference. TRIAL REGISTRATION NUMBER: ChiCTR2600116040.