Stroke
Conditions
Brief summary
This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.
Detailed description
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.
Interventions
DEVICEmulti-sensory stimulation immersive VR+ treadmill training
Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group
DEVICEtreadmill training
Only treadmill training in treadmill training group
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. The first onset of stroke is diagnosed and confirmed according to the requirements of stroke 2. The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is less than 34. 3. 18-85 years of age. 4. Able to walk with minor assistance 5. MMSE score of 20-30 and ability to understand and follow instructions during the trial 6. Able to sign an informed consent form.
Exclusion criteria
1. Severe visual or hearing impairments. 2. Pregnant or breastfeeding women. 3. Patients with unrepaired cranial bone flaps or metallic implants following brain surgery. 4. Presence of other conditions affecting lower limb motor function, such as osteoarthritis or recent lower limb fractures. 5. History of severe psychiatric disorders, other neurological diseases, acute cardiopulmonary dysfunction, multiple organ failure, brain tumours, or epilepsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment- Lower Extremity | 30 days (Adjust according to the actual situation of patients) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Near-Infrared Spectroscopy Detection - Supplementary Motor Area - Oxygenated Hemoglobin (fNIRS Detection - SMA - HbO2) | 30 days (Adjust according to the actual situation of patients) | 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. |
| Berg balance scale | 30 days (Adjust according to the actual situation of patients) | 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. |
| 3D Gait Analysis - Affected Side Step Width | 30 days (Adjust according to the actual situation of patients) | 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. |
| Montreal Cognitive Assessment（MoCA） | 30 days (Adjust according to the actual situation of patients) | 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. |
| Mini-Mental State Examination (MMSE) | 30 days (Adjust according to the actual situation of patients) | 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. |
Countries
China
Contacts
CONTACTDingqun Bai
CONTACTZheng Yang
STUDY_CHAIRDingqun Bai
First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed