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. 2026 Jun 3;16(6):e118266. doi: 10.1136/bmjopen-2026-118266

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

Ji-Ling Li 1, Fan-Long Meng 2, Jie Ma 3,4, Jia-Jia Wu 3,4, Shuang He 2, Jun-Peng Zhang 5, Zhi-Jie Xu 6, Yu-Xin Zheng 2,*, Yuan-Dong Mei 7,*, Xu-Yun Hua 4,8,*, Jian-Guang Xu 3,4,6,*
PMCID: PMC13239377  PMID: 42236103

Abstract

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.

Keywords: Stroke, Virtual Reality, Clinical Trial, Cognitive dysfunction

Strengths and limitations of this study.

  • This study evaluates an immersive virtual reality (VR)-based cognitive rehabilitation programme designed to enhance engagement through multisensory and interactive training for patients with poststroke cognitive impairment.

  • The integration of VR-based cognitive training with multimodal neuroimaging techniques (functional MRI and electroencephalogram) enables exploratory investigation of potential neural correlates associated with cognitive rehabilitation.

  • A multidimensional assessment framework combining standardised clinical cognitive measures with exploratory neuroimaging outcomes is used to evaluate the feasibility and preliminary effects of the intervention.

  • As a single-centre randomised controlled trial with a modest sample size, the study may have limited generalisability and is not powered for subgroup or confirmatory neuroimaging analyses.

  • The relatively short intervention and follow-up periods may limit the assessment of long-term cognitive outcomes.

Introduction

Over the past decade, stroke has emerged as the second leading cause of death globally, posing an extremely serious threat to human life and health.1,3 Its incidence has long ranked among the highest across all diseases, characterised by ‘three highs’: high incidence, high disability and high recurrence.4,8 Epidemiological data indicate that China accounts for approximately one-quarter of all global stroke cases. As the population ages, this burden is expected to continue rising in the coming decades, presenting a profound challenge to the national public health system.9,11 Poststroke cognitive impairment (PSCI) is one of the most common and clinically significant complications of stroke, with an incidence ranging from 20% to 80%.12,14 Clinical manifestations of PSCI span from mild cognitive impairment to severe dementia, affecting multiple cognitive dimensions including attention, executive function, language ability, working memory, visuospatial skills and orientation. This significantly impairs patients’ functional recovery and social participation,15 making PSCI a key bottleneck in post-stroke rehabilitation and a major focus of public concern.16 17

Despite the availability of numerous current PSCI rehabilitation approaches,18,20 effective disease-modifying treatments remain lacking. While lifestyle modifications, such as smoking, alcohol cessation and physical activity,21 have been associated with reduced risks of dementia recurrence22 and acute stroke,23 no clear scientific consensus exists regarding their impact on cognitive impairment.24 25

Currently, traditional cognitive rehabilitation methods mainly consist of paper-and-pencil training and computer-assisted training. However, these approaches face several limitations: first, their lack of interactivity often leads to patient disinterest.26 Second, single-sensory stimulation alone rarely promotes activation of multimodal neural networks. Third, long-term patient compliance is relatively low, which affects the rehabilitation outcomes.27 28 Thus, there is an urgent need for a safe, reliable and effective rehabilitation modality for PSCI.29

Virtual reality (VR) is an immersive sensory presentation technology, specifically a multisensory interactive display system.30 31 It typically comprises a high-performance computer that generates visual content, paired with a tracker to monitor the user’s position and orientation in real time—allowing the virtual interface to update dynamically in response to the user’s movements.32 As a non-invasive intervention,33 VR leverages computing technology to create a virtual environment that integrates multimodal stimuli (including visual,34 tactile and auditory inputs),35 enabling patients to feel as though they are in a real-life scenario.36 Through interaction with virtual objects, patients complete targeted rehabilitation tasks under the combined influence of visual, auditory and tactile stimuli. This immersive experience not only enhances the realism of the training, but also significantly boosts patients’ active engagement and the enjoyment of the training process.37 38 When patients complete these tasks in the virtual environment, they receive immediate feedback. Additionally, the system’s detailed data recordings enable the efficacy assessment and personalised adjustments to the intervention.39

Previous studies have suggested that VR-based interventions for PSCI are feasible and may confer potential benefits for cognitive recovery, although the existing evidence remains limited and heterogeneous.40,42 On this basis, we developed an immersive VR-based cognitive rehabilitation system designed to support cognitive training through structured multisensory stimulation.

The VR system (NeuCir-VR-II) incorporates daily life-oriented scenarios and gamified tasks to deliver integrated visual and auditory stimulation with interactive task execution and real-time performance feedback, with the aim of enhancing engagement and adherence during cognitive training (figure 1).

Figure 1. Multisensory VR system configuration for poststroke cognitive rehabilitation. (A) An illustration of a VR experience, where the user interacts with the virtual environment using handheld controllers within a space monitored by tracking cameras; (B) This image provides a physical representation of the devices from Part A, showcasing all the necessary hardware components of a complete VR system. VR, virtual reality.

Figure 1

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Building on the immersive VR-based cognitive rehabilitation framework, this study incorporates resting-state neuroimaging assessments, including electroencephalogram (EEG) and functional MRI (fMRI), to generate hypothesis-forming insights into potential neurophysiological correlates of cognitive improvement in patients with PSCI. The neuroimaging component is designed to characterise changes in global brain activity and functional network organisation associated with VR-assisted cognitive training. Specifically, resting-state fMRI will be used to examine spontaneous neural activity and functional connectivity within predefined cognition-relevant regions and large-scale networks implicated in cognitive control and attention, while EEG will provide complementary information on temporal dynamics and frequency-domain characteristics of cortical activity. Given the modest sample size and short intervention duration, neuroimaging outcomes will be interpreted descriptively and used to complement clinical cognitive measures, rather than serve as surrogate efficacy endpoints. Any observed neural changes will be reported transparently as exploratory correlates of behavioural improvement and used to inform future, adequately powered mechanistic studies.

Therefore, the primary objective of this study is to evaluate the clinical feasibility and potential efficacy of the immersive VR-based cognitive rehabilitation system (NeuCir-VR-II) for improving cognitive function in patients with PSCI. The secondary objective is to elucidate the neurophysiological mechanisms underlying VR-assisted recovery by analysing changes in resting-state neural activity and functional connectivity using EEG and fMRI.

Methods

Study design

This single-centre, observer-blind, randomised controlled trial was prospectively registered in the Chinese Clinical Trial Registry (ChiCTR) prior to participant recruitment (Registration ID: ChiCTR2600116040). The study protocol was approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Approval No.: 2025–1933-273-02).

Participants recruitment will commence on 20 January 2026 and is expected to close on 1 March 2027.

A total of 60 participants with PSCI will be recruited from Shuguang Hospital and randomly allocated to one of two parallel groups: an intervention group receiving immersive VR training or a control group receiving conventional rehabilitation. The overall trial process is illustrated in figure 2. Screening assessments will focus on determining participant eligibility, including basic patient information, time and type of stroke, use of external braces and cognitive evaluation using the MoCA.43 Participants meeting all inclusion criteria and not meeting any of the exclusion criteria will proceed to baseline evaluation. Otherwise, they will be excluded. This study protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 statement.

Figure 2. The flowchart of the trial. HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale; LMT, Logical Memory Test; MMSE, Mini-Mental State Examination; MoCA, Montreal Cognitive Assessment; SDMT, Symbol Digit Modalities Test; STT, Shape Trail Test; VR, virtual reality.

Figure 2

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Participants diagnostic criteria

Stroke will be diagnosed in accordance with the WHO definition, characterised by rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting more than 24 hours or leading to death, and no apparent cause other than of vascular origin. All diagnoses will be verified by clinical presentation and neuroimaging findings (CT or MRI).44

Inclusion criteria

  1. First episode of unilateral ischaemic or haemorrhagic stroke confirmed by MRI or CT, in accordance with the definition of the WHO.

  2. Aged 18–70 years, with no gender restriction.

  3. The duration since stroke onset is between 3 and 6 months.

  4. Score on the Montreal Cognitive Assessment (MoCA) ranging from 18 to 25 points, indicating mild cognitive impairment.

  5. No severe visual or auditory impairment, or with mild visual/auditory impairment that does not affect cooperation in completing VR training.

  6. Voluntary participation in the study and provision of written informed consent.

Exclusion criteria

  1. Exclude patients with sensory or motor dysfunction that may interfere with VR intervention.

  2. Intolerance to VR equipment (eg, motion sickness, history of epilepsy).

  3. Presence of contraindications to fMRI or EEG examinations (eg, cardiac pacemakers, intracranial metallic foreign bodies, skin infections, history of epilepsy or severe motion sickness).

  4. A history of cognitive impairment caused by mental illness, neurological diseases, internal medical conditions or substance abuse.

  5. Special physiological status: pregnant or lactating women.

  6. Concurrent participation in other clinical trials.

Discontinuation criteria

  1. Participants voluntarily request to withdraw from the clinical study.

  2. Failure to complete the required clinical assessments, which significantly compromises data collection.

  3. Receipt of unauthorised concurrent intervention programmes during the study period.

Participants who meet the inclusion criteria and have no exclusion criteria will be assigned to the study. After getting signed written informed consents, the participants are enrolled.

Sample size

The sample size was calculated based on the primary outcome, defined as the change in MoCA score after the 2 week intervention. The effect size (Cohen’s f=0.25) was informed by effect sizes reported in a previous randomised controlled trial of VR-based cognitive rehabilitation in patients with stroke.45 With a two-sided significance level of 0.05 and a statistical power of 90%, the minimum required sample size was 48 participants, as calculated using G*Power software (V.3.1.9.7). Allowing for an anticipated dropout rate of 20%, the total sample size was increased to 60 participants, with 30 participants allocated to each group.

Patient and public involvement

Patient representatives, including individuals with stroke and their caregivers, were involved in the design of this study protocol. They contributed to the selection of outcome measures, the development of intervention procedures and the review of the participant information sheet. Their feedback was incorporated to ensure that the study was patient-centred, feasible and acceptable to the target population.

Randomisation and blinding

An independent statistician, who will not be involved in participant recruitment, intervention delivery or outcome assessment, will generate the random allocation sequence using a computer-based block randomisation method with a fixed block size of four to ensure balanced group sizes between the two study arms. To ensure allocation concealment, the randomisation sequence will be implemented using sequentially numbered, opaque, sealed envelopes (SNOSE). A researcher not otherwise involved in the trial will open the next envelope only after a participant has completed baseline assessment and has been formally enrolled in the study. This procedure will ensure that group assignment remains concealed from investigators and outcome assessors until allocation.

Due to the nature of the intervention, blinding of participants and therapists is not feasible. However, outcome assessors and data analysts will remain blinded to group allocation throughout the study period to minimise assessment and analysis bias. To maintain assessor blinding, all outcome assessments will be conducted by independent evaluators who are not involved in participant recruitment or intervention delivery and who will be unaware of group assignments. Participants will be instructed not to disclose details of their intervention to the assessors. In addition, assessors will perform evaluations in a separate location from the intervention setting to reduce the risk of unintentional unblinding. Blinding will be maintained until completion of the final follow-up assessment and data locking. Any instances of unblinding, if they occur, will be documented and reported.

Interventions

All participants will receive routine rehabilitation (including physical therapy, occupational therapy) throughout the study. The intervention period will last 2 weeks, with all patients completing five 30-minute training sessions per week. Both groups will additionally undergo 30-minute daily cognitive rehabilitation training for 2 weeks (5 days/week). The only difference between the two groups is the format of cognitive training: the experimental group will receive VR-based training, while the control group will receive traditional non-VR training.

Control group (Traditional cognitive rehabilitation)

Training delivery: Will be administered by a single experienced therapist with over 5 years of clinical experience in poststroke cognitive rehabilitation to ensure consistency.

Training content (aligned with the cognitive domains targeted by the experimental group).

Attention: Paper-and-pencil tasks (number cancellation, visual search for target symbols).

Memory: Verbal recall (memorising five common words) and visual recognition (identifying previously displayed images).

Executive function: Sequencing daily activities (arranging ‘waking up—brushing teeth—eating’ in logical order) and simple arithmetic.

Motor–cognitive integration: Sorting physical objects by colour/shape and folding paper according to verbal instructions.

Social cognition: Role-play with the therapist (simulating a conversation in a grocery store) to practice communication skills.

Training structure: 30 min per day, with each task lasting 5–6 min and 1-minute breaks between tasks (extendable to 2 min if the patient feels fatigued).

Difficulty adjustment: Tailored to baseline MoCA subscores (simple: <4; moderate: 4–6; difficult: >6). Adjustments will be made every 3 days based on task accuracy (difficulty increased if accuracy >80%; difficulty decreased if accuracy <60%).

Experimental group (VR-based cognitive rehabilitation)

Training delivery: VR training will be conducted using the NeuCir-VR-II system, guided by a certified therapist (with a VR operation competency test score ≥90%).

Training content (five modules, with one game selected from each module daily based on the patient’s interest; each module targets cognitive domains matching those of the control group).

Immersive scenario training: Searching for and ‘purchasing’ 3–5 designated items in a virtual supermarket (trains attention, memory and spatial cognition; 5 min) (figure 3).

Figure 3. Virtual supermarket shopping experience.

Figure 3

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Sensorimotor training: ‘Fruit Challenge’ (catching virtual fruits) and item organisation (enhances motor control and brain-body perception; 5 min) (figure 4).

Figure 4. A fruit-slicing game.

Figure 4

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Cognitive stimulation training: Dynamically formulate corresponding instructions to help stimulate their cognitive and coordination functions. (stimulates cognitive function; 5 min) (figure 5).

Figure 5. Executive function testing.

Figure 5

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Gamified cognitive training: Number-reading games with progressive difficulty (improves attention and logical thinking; 5 min) (figure 6).

Figure 6. Digital game.

Figure 6

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Social interaction simulation: Practicing understanding of expressions and tones in virtual social scenarios (eg, party conversations; enhances social cognition; 5 min) (figure 7).

Figure 7. Virtual social scenario training.

Figure 7

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Training structure: 30 min per day (five modules×5 min) with 1-minute breaks between modules (extendable based on fatigue).

Difficulty adjustment: Consistent with the criteria for the control group (based on baseline MoCA scores and 3-day task accuracy).

We will also evaluate the acceptability and safety of the VR intervention. Adverse events such as headache, dizziness, nausea, vomiting, fatigue or seizures will be considered primary safety outcomes. Prior to and following each treatment session, participants will be asked about their physical condition and whether they experienced any discomfort. For each patient, adverse events will be assessed before and after every session using the Simulator Sickness Questionnaire (SSQ), which is widely regarded as the gold standard for evaluating physical responses following exposure to VR environments.

Outcomes

The primary outcome indicator of this study is the score of the MoCA scale at different time points, which will be used to assess overall cognitive function; the secondary outcome indicators include scores from multiple neuropsychological scales such as the Mini-Mental State Examination (MMSE)46 and the Stroop Color-Word Association Test,47 as well as brain function detection data including fMRI and EEG, which will be used to evaluate various cognitive dimensions, emotional states and changes in brain networks respectively; relevant data will be collected at three time points: before intervention, immediately after the completion of all interventions and 4 weeks after the completion of all interventions. These neuroimaging assessments are not intended to test specific mechanistic hypotheses or to establish causal relationships between the intervention and neural changes, but rather to generate hypothesis-forming insights into potential neural correlates associated with VR-based cognitive rehabilitation.

Primary outcome

MoCA was selected as the primary outcome because it is a widely used and validated global cognitive screening tool with high sensitivity for detecting mild cognitive impairment and PSCI. It provides a comprehensive assessment across multiple cognitive domains, including attention, executive function, memory, language and visuospatial ability, making it well suited to capture overall cognitive changes following rehabilitation interventions in PSCI populations.

Importantly, changes in MoCA scores are clinically interpretable and closely associated with functional independence and activities of daily living after stroke; therefore, even modest improvements may reflect meaningful functional gains relevant to clinical decision-making. The sample size of the present study was calculated based on expected changes in MoCA scores, consistent with its role as the primary efficacy endpoint.

Secondary outcomes

1. Domain-specific cognitive function: To assess changes in specific cognitive domains, the following standardised neuropsychological tests will be administered:

MMSE: The MMSE is a widely used screening tool for global cognitive function, assessing orientation, memory, attention and calculation, language and visuospatial ability. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Education-adjusted cut-off values will be applied (illiteracy >17, primary education >20 and middle school or above >24). The MMSE will be administered at baseline (T0), immediately postintervention (T1) and at 4-week follow-up (T2).

Stroop Colour Word Test: Based on the Stroop effect, which is the interference of dominant responses with non-dominant responses. When a participant is asked to respond to the colour of a font that has a colour meaning, responding to the meaning of the word itself is a dominant response, whereas responding to the colour of the font is a non-dominant response. Generally, a score of >39 is normal.

Logical Memory Test (LMT): The LMT is used to assess both immediate and delayed verbal memory. Participants will be required to recount the contents of three short stories narrated by a trained assessor. A total score of 9 or higher is considered indicative of intact memory function.

Symbol Digit Modalities Test (SDMT): The SDMT is a measure of information processing speed and attention. In this test, participants convert meaningless geometric symbols into corresponding numbers using a reference key, and the number of correct responses within a 90 s time window is recorded. The SDMT will be administered at three time points: preintervention, postintervention and follow-up.

Shape Trail Test (STT): The STT is divided into two parts, Part A and Part B. Each part consists of practice and test questions. Part A requires subjects to connect randomly arranged numbers in sequence as fast as possible, while Part B requires subjects to alternate between the two shapes when connecting the numbers sequentially. Part A will be used to assess attention, while Part B will be used to assess processing speed and executive control. It will be assessed once at each of the three points: preintervention, postintervention and follow-up.

2. Emotional and psychological status: Given the close association between cognitive impairment and affective symptoms after stroke, emotional status will be evaluated using the following scales

Hamilton Anxiety Rating Scale (HAMA): Anxiety symptoms will be assessed using the 14-item HAMA, with each item scored on a 5-point scale (0–4). Higher total scores indicate greater anxiety severity. A total score ≥14 will be used as the threshold for clinically relevant anxiety. Assessments will be conducted at baseline, immediately postintervention and at follow-up.

Hamilton Depression Rating Scale (HAMD): Depressive symptoms will be evaluated using the HAMD, a widely used clinician-rated measure of depression severity. Items are primarily scored on a 5-point scale (0–4), with higher scores reflecting more severe depressive symptoms. Assessments will be performed at baseline, postintervention and follow-up.

3. Neurophysiological and neuroimaging outcomes: To explore potential neural correlates associated with VR-based cognitive rehabilitation, neurophysiological and neuroimaging data will be collected as exploratory outcomes:

fMRI: Resting-state fMRI and T1-weighted structural images will be acquired using a 3.0-Tesla scanner (Siemens Verio, Erlangen, Germany) at Shuguang Hospital. Participants will be scanned in the supine position with eyes closed, instructed to remain awake and head motion will be minimised using foam padding. Resting-state fMRI will be obtained using a gradient-echo echo-planar imaging sequence with the following parameters: repetition time (TR)=2000 ms, flip angle (FA)=90°, field of view (FOV)=230 mm × 230 mm, matrix=64 × 64, slice thickness=3mm, 43 slices. T1-weighted images will be acquired using a three-dimensional sequence with the following parameters: TR=1900 ms, echo time (TE)=2.93 ms, FA=9°, FOV=256 mm × 256 mm, matrix=256 × 256, slice thickness=1 mm. fMRI analyses will be conducted as exploratory and descriptive investigations to characterise changes in resting-state brain activity and functional connectivity before and after the intervention.

EEG: EEG data will be collected using a 128-channel EGI EEG system arranged according to the international 10–20 system, with a sampling rate of 1000 Hz and Cz as the reference electrode. Electrode impedance will be maintained below 10 kΩ. EEG recordings will be obtained under resting-state conditions with eyes open and eyes closed. EEG data will be processed using EEGLAB (V.2025.0.0). Analyses will focus on exploratory and descriptive assessments of global brain activity patterns in the time and frequency domains. Event-related potential components will be examined in an exploratory manner without predefined confirmatory hypotheses.

Participant timeline

The detailed schedule of enrolment, interventions and assessments is illustrated in figure 8. All eligible participants will undergo a 2-week treatment period. Baseline assessments (T0)—including the collection of concomitant medications and comprehensive clinical and neuroimaging evaluations—will be conducted prior to randomisation. Following the intervention, subsequent assessments for all primary and secondary outcomes will be performed immediately postintervention (T1) and at the 4-week follow-up (T2) to monitor treatment efficacy and functional changes. To minimise bias, all assessments at T0, T1 and T2 will be conducted by independent assessors blinded to group allocation.

Figure 8. The schedule of enrolment, interventions and assessments. EEG, electroencephalogram; fMRI, functional MRI; HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale; LMT, Logical Memory Test; MMSE, Mini-Mental State Examination; MoCA, Montreal Cognitive Assessment; SDMT, Symbol Digit Modalities Test; SSQ, Simulator Sickness Questionnaire; Stroop test, Stroop Color-Word Association Test; STT, Shape Trail Test.

Figure 8

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Data management

All trial data will be managed in strict accordance with confidentiality agreements. Clinical assessment data will be collected using standardised paper case report forms and subsequently entered into a secure, password-protected electronic database. To ensure data accuracy and quality, two independent researchers will perform a dual data entry procedure. All personally identifiable information will be anonymised and stored separately from the master data set. Electronic data, including neuroimaging (fMRI) and neurophysiology (EEG) files, will be regularly backed up and stored on secure, restricted-access servers at Shuguang Hospital. Only the designated principal investigator and authorised statistician will have access to the final trial dataset.

Monitoring plan

Given the non-invasive and low-risk nature of VR-based cognitive rehabilitation interventions, a formal independent Data and Safety Monitoring Board will not be established. Instead, trial monitoring and auditing will be conducted by a designated internal oversight committee at the hospital, which will operate independently of the direct research team. This committee will periodically review trial progress, data integrity and protocol adherence. In addition, any adverse events (eg, VR-induced motion sickness, dizziness or fatigue) will be documented in detail using the SSQ, graded for severity and reported promptly to the Ethics Committee to ensure participant safety throughout the trial.

Clinical data analysis

Clinical data will be analysed using SPSS software V.24.0 (SPSS, Chicago, Illinois, USA). Continuous data will be presented as mean and SD, while categorical data will be presented as counts and percentage change. For demographic data, such as gender, education and side of hemiplegia, the χ² test will be used for analysis. Before analysing the results of the clinical assessment and demographic data, such as age, height and weight, the Shapiro-Wilk test will be used to determine whether they conformed to a normal distribution. Continuous variables that are not normally distributed were assessed using the Mann-Whitney U test, while normally distributed variables will be analysed using the independent samples t-test and analysis of covariance (ANCOVA). When ANCOVA is performed, age and baseline Fugl-Meyer Assessment of the Lower Extremity scores will be used as covariates. Statistical significance will be set at p<0.05, and all reported p values will be two-tailed.

Analysis of resting-state fMRI data

Resting-state fMRI data will be processed and analysed using SPM12 implemented in MATLAB R2022b. Resting-state fMRI is included as an exploratory outcome to describe changes in brain functional connectivity patterns before and after the intervention. Analyses will be conducted in a descriptive and exploratory manner within predefined regions of interest relevant to cognitive processing. Given the exploratory nature of this study and the limited sample size, no formal hypothesis testing or adjustment for multiple comparisons is planned, and findings will be interpreted as hypothesis-generating.

Discussion

The present study protocol describes a single-centre, randomised controlled trial designed to evaluate the feasibility and preliminary effectiveness of an immersive VR-based cognitive rehabilitation programme in patients with PSCI. The trial aims to compare VR-based cognitive training with conventional rehabilitation using standardised clinical outcomes, while incorporating exploratory neuroimaging assessments. In recent years, VR technology has been increasingly applied in neurorehabilitation, primarily for motor recovery.48 In contrast, the application of VR interventions for poststroke cognitive rehabilitation remains relatively limited, and existing evidence is heterogeneous and inconclusive,49 50 despite the potential of immersive environments to enhance engagement and task adherence26 51

While previous studies have explored scenario-based VR tasks (eg, virtual supermarket shopping or cooking) for cognitive training in dementia populations,52 53 their effectiveness in patients with PSCI appears variable.54 Systematic reviews emphasise that VR’s effects on poststroke cognitive function require validation through rigorously designed randomised controlled trials.55 To address these gaps, the present trial implements a structured VR-based cognitive rehabilitation programme. Furthermore, resting-state fMRI and EEG are incorporated to provide hypothesis-generating insights into potential neurophysiological changes associated with cognitive training, guiding the selection of candidate neural markers for future investigation.3 56 Several limitations of this study should be acknowledged. First, the relatively short intervention period and follow-up duration may limit the ability to assess long-term cognitive outcomes and sustained changes over time. Second, the single-centre design and modest sample size may restrict the generalisability of the findings and preclude subgroup analyses, such as comparisons between ischaemic and haemorrhagic stroke subtypes. Third, although multiple domain-specific cognitive assessments are included as secondary outcomes, the primary outcome focuses on global cognitive function, which may reduce sensitivity to changes within specific cognitive domains. Finally, while we employed SNOSE to ensure allocation concealment, this manual randomisation method has inherent limitations compared with centralised web-based systems. Manual systems are more susceptible to administrative errors or potential subversion of the allocation sequence if not strictly monitored. To mitigate this, we assigned a researcher independent of the recruitment and intervention processes to manage the envelopes, ensuring that group assignments remained concealed until formal enrolment.

To address these limitations, future research should consider multicentre randomised controlled trials with larger sample sizes and extended follow-up periods, and the utilisation of centralised web-based randomisation systems. More detailed stratification by stroke subtype, repeated neuroimaging assessments and the inclusion of more domain-specific cognitive outcome measures may help to further elucidate the clinical and neurophysiological characteristics associated with VR-based cognitive rehabilitation. Advanced neuroimaging approaches, such as diffusion tensor imaging,57 may also provide complementary information regarding structural connectivity changes related to cognitive recovery.58

In summary, this randomised controlled trial is designed to evaluate the feasibility and preliminary effectiveness of immersive VR-based cognitive rehabilitation in patients with PSCI.59 The findings are expected to inform the design of future large-scale trials and contribute to the development of evidence-informed VR-based cognitive rehabilitation strategies in clinical practice.

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.

Footnotes

Funding: This work was supported by the National Natural Science Foundation of China (Grant Nos.: 82272583, 82172554, 82272589, 82472613); Shanghai Municipal Special Fund for Promoting High-Quality Industrial Development (240404); Shanghai Oriental Talents Program (Grant No.: QNWS2024084, QNJY2024077); Shanghai Rising-Star Program (Grant No.: 23QA1409200, 24QA2709300); Shanghai Hospital Development Center Foundation-Shanghai Municipal Hospital Rehabilitation Medicine Specialty Alliance (SHDC22023304). Shanghai ‘Rising Stars of Medical Talent’-Distinguished Young Medical Talent Program; Shanghai Talent Development Fund (2021074);

Prepub: Prepublication history for this paper is available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2026-118266).

Patient consent for publication: Not applicable.

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

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