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This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.
This was single-blind randomized controlled intervention study. Each stroke subject underwent screening period, baseline assessment period, intervention period, endpoint assessment period.
The screening period include the verification of inclusion/exclusion criteria and the acquisition of informed consent.
Baseline and endpoint assessment period include motor function related scales were evaluated (muscle strength, muscle tone, Fugl-Meyer scale, Berg balance scale); cognitive function related scale assessment [Brief Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test, Shape connection test A.B, standardized digital modal experiment, auditory word Learning Test], emotional correlation scale assessment (Hamilton Depression Scale, Hamilton Anxiety Scale), and activity of daily living scale ADL scale. Meanwhile, quantitative evaluation of motor function three-dimensional gait detection and assessment of brain functional activation (fNIRs tests and fMRI) were synchronously completed.
The intervention period included multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity in the experimental group and only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions).
Preliminary validation of effectiveness assessment includes Fugl-Meyer scale, Berg balance scale, and three-dimensional gait detection. Preliminary validation of the safety assessment includes fall and dizzy incidents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR+treadmill training group | Experimental | Multi-sensory stimulation immersive VR+ treadmill training with suitable for training intensity. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions). |
|
| treadmill training group | Active Comparator | Only treadmill training similarly with suitable for training intensity in the control group. 20 minutes a day for 30 days, a total of 600 minutes (training frequency is adjusted according to the patient's own conditions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-sensory stimulation immersive VR+ treadmill training | Device | Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment- Lower Extremity | The Fugl-Meyer Assessment of Motor Recovery after Stroke - Lower Extremity (FMA-LE) evaluates lower extremity motor impairment through 17 items assessing reflexes, synergy patterns, and coordination. Each item is scored 0-2 (total range 0-34), with higher scores indicating better motor function. The total is the sum of all items, including motor (0-30) and coordination (0-4) subcomponents. | 30 days (Adjust according to the actual situation of patients) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2) | Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2) measures cortical activation in the supplementary motor area via oxygenated hemoglobin concentration changes. Values are reported as changes from baseline in mmol/L, with increases indicating greater neural activity during motor tasks. |
| Measure | Description | Time Frame |
|---|---|---|
| Fall incidents | Safety assessment | 30 days (Adjust according to the actual situation of patients) |
| Dizzy incidents | Safety assessment | 30 days (Adjust according to the actual situation of patients) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dingqun Bai | Contact | 023-89011334 | baidingqun2014@163.com | |
| Zheng Yang | Contact | zhengyangvivi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dingqun Bai | First Affiliated Hospital of Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University, First Branch | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41932701 | Derived | Yang Z, Lu Q, Chen D, Tang L, Ran T, Yang L, Bai D. Multidimensional effects of virtual reality on motor dysfunction in patients who had a stroke: study protocol for a prospective, randomised, controlled clinical trial. BMJ Open. 2026 Apr 3;16(4):e108362. doi: 10.1136/bmjopen-2025-108362. |
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The deidentified individual participant data (IPD) that underlie the results reported in this study will be available beginning 6 months and ending 5 years after publication. Data will be shared with researchers who provide a methodologically sound proposal for use in individual participant data meta-analysis or replication of study findings. Proposals should be directed to corresponding author's email. To gain access, data requestors will need to sign a data access agreement.
2027.6.30
Access Criteria: Data will be available to researchers who submit a scientifically sound proposal. Requestors must agree to use the data only for the stated research purpose and sign a data access agreement. Ethical approval may be required depending on the proposed study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2024 | Mar 16, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2024 | Mar 14, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| treadmill training | Device | Only treadmill training in treadmill training group |
|
| 30 days (Adjust according to the actual situation of patients) |
| Berg balance scale | Berg Balance Scale (BBS) is a 14-item performance-based measure that assesses static and dynamic balance abilities in older adults or individuals with impaired balance function. Each item is rated on a 5-point ordinal scale ranging from 0 (unable to perform) to 4 (able to perform independently), yielding a total score range of 0 to 56, with higher scores indicating better balance and lower fall risk. The total score is calculated by summing all 14 individual item scores, and it is commonly used to evaluate balance impairment and predict fall risk in clinical populations. | 30 days (Adjust according to the actual situation of patients) |
| 3D Gait Analysis - Affected Side Step Width | 3D Gait Analysis - Affected Side Step Width: This parameter measures the lateral distance between the two feet during walking, derived from three-dimensional motion analysis, focusing on the affected side. Units are centimeters (cm), with typical values ranging from approximately 5 to 20 cm depending on individual factors. Higher values represent wider step width, which may indicate balance deficits or compensatory strategies; lower values may also reflect instability. The clinical interpretation of better or worse outcomes is context-dependent. | 30 days (Adjust according to the actual situation of patients) |
| Montreal Cognitive Assessment（MoCA） | Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment, evaluating visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It comprises 30 items with a total score range of 0 to 30, where higher scores indicate better cognitive function (≥26 considered normal). The total is the sum of all subdomain scores. | 30 days (Adjust according to the actual situation of patients) |
| Mini-Mental State Examination (MMSE) | Mini-Mental State Examination (MMSE) is a brief cognitive screening tool assessing orientation, registration, attention and calculation, recall, language, and visual construction. It consists of 30 items with a total score range of 0 to 30, where higher scores indicate better cognitive function (scores ≥24 are generally considered normal). The total score is calculated by summing all item scores. | 30 days (Adjust according to the actual situation of patients) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |