This study protocol describes a single-centre randomised controlled trial designed to assess the rehabilitative efficacy of VR-based cognitive training in patients with poststroke cognitive impairment over a 2-week intervention period with follow-up at 4 weeks post-intervention.
Key Findings
Methods
The trial will enrol 60 stroke patients randomised to either a conventional rehabilitation group or a VR intervention group.
Total sample size of 60 patients who had a stroke.
Randomisation into two groups: conventional rehabilitation group (control) and VR intervention group (experimental).
Trial registered under ChiCTR2600116040 and approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (2025-1933-273-02).
Methods
The intervention protocol consists of 2 weeks of training with five 60-minute sessions per week, combining conventional rehabilitation with either traditional or VR-based cognitive training.
Intervention duration is 2 weeks, with five sessions per week.
Each session lasts 60 minutes total.
Both groups receive 30 minutes of conventional rehabilitation training per session.
The control group receives 30 minutes of traditional cognitive rehabilitation for the remaining time, while the experimental group receives 30 minutes of VR-based cognitive rehabilitation training.
Methods
The primary outcome measure is the Montreal Cognitive Assessment (MoCA), with multiple secondary cognitive outcomes also assessed.
Primary outcome: Montreal Cognitive Assessment (MoCA).
Secondary outcomes include the Mini-Mental State Examination (MMSE), Trail Making Test (TMT), and Stroop Test.
Assessments will be conducted at three time points: baseline (T0), immediately post-intervention (T1), and 4 weeks after completing the intervention (T2).
Outcomes target multiple cognitive domains including memory, attention, and executive function.
Background
The VR-based cognitive training system was developed based on principles of neuroplasticity and multisensory integration to address the complexity of neural networks involved in poststroke cognitive impairment.
The system is described as an 'innovative dynamic cognitive training system integrated with virtual reality (VR) technology.'
Design rationale draws on neuroplasticity and multisensory integration principles.
The system is intended to address limitations of existing interventions such as pharmacotherapy and traditional cognitive training, which are described as 'limited in scope and variable in efficacy.'
PSCI is characterised by deficits in one or more cognitive domains including memory, attention, and executive function.
Methods
The trial incorporates exploratory neuroimaging assessments to provide hypothesis-generating information regarding brain functional changes associated with the VR intervention.
Neuroimaging outcomes are described as 'exploratory' and intended to 'generate hypothesis-forming insights into potential neural correlates.'
Neuroimaging data are characterised as providing 'descriptive and hypothesis-generating information' rather than confirmatory findings.
The study aims to evaluate 'preliminary effectiveness' of the VR-based intervention in improving 'multidimensional cognitive function.'
The neuroimaging component is explicitly framed as exploratory rather than as a primary or secondary outcome.
Background
Poststroke cognitive impairment is described as a prevalent complication of stroke that co-occurs with motor dysfunction and negatively impacts activities of daily living and quality of life.
PSCI is characterised by deficits in one or more cognitive domains such as memory, attention, and executive function.
Beyond increasing mortality and disability risks, PSCI 'frequently co-occurs with motor dysfunction.'
PSCI 'impairs activities of daily living and reduces quality of life.'
Clinical practice is described as currently lacking 'targeted therapeutic strategies' for PSCI.
What This Means
This research describes the protocol for a clinical trial testing whether virtual reality (VR) technology can help stroke survivors recover cognitive abilities such as memory, attention, and problem-solving. Many people who survive a stroke develop cognitive impairment — difficulties thinking, remembering, and concentrating — which can significantly affect their independence and quality of life. Current treatments for this problem have limited effectiveness, so researchers are testing a new VR-based training system designed to engage multiple senses and promote brain recovery based on how the brain adapts and rewires itself after injury.
In the trial, 60 stroke patients will be randomly assigned to one of two groups. Both groups receive standard rehabilitation, but the experimental group also does 30 minutes of VR-based cognitive exercises per session, while the control group does 30 minutes of traditional cognitive training instead. The program runs for 2 weeks, with five one-hour sessions per week. Participants will be tested on standardised cognitive assessments before the intervention, immediately after it ends, and again 4 weeks later to see whether any improvements are maintained. Brain imaging will also be done on an exploratory basis to look for changes in how the brain functions.
This research suggests that VR technology may offer a more engaging and potentially more effective way to help stroke survivors rehabilitate their thinking skills compared to conventional methods. Because this is a study protocol paper — meaning it describes the plan for a trial that has not yet reported results — the findings about effectiveness are not yet available. The trial is designed to generate preliminary evidence and new hypotheses about how VR affects the brain after stroke, which could inform larger, more definitive studies in the future.
Li J, Meng F, Ma J, Wu J, He S, Zhang J, et al.. (2026). Immersive virtual reality for cognitive rehabilitation in patients who had a stroke: study protocol for a randomised controlled trial.. BMJ open. https://doi.org/10.1136/bmjopen-2026-118266