About this trial
This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The first onset of stroke is diagnosed and confirmed according to the requirements of stroke
The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is less than 34.
18-85 years of age.
Able to walk with minor assistance
Disqualifiers
Severe visual or hearing impairments.
Pregnant or breastfeeding women.
Patients with unrepaired cranial bone flaps or metallic implants following brain surgery.
Presence of other conditions affecting lower limb motor function, such as osteoarthritis or recent lower limb fractures.
Trial design
Parallel
Treatments tested in this trial
multi-sensory stimulation immersive VR+ treadmill training
DeviceTreadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group
treadmill training
DeviceOnly treadmill training in treadmill training group
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
Fall incidents
Safety assessment
Dizzy incidents
Safety assessment
Sponsors and contacts
Click on the lead sponsor to view all of their trials.