Safety and Efficacy of Multisensory Stimulation Virtual Reality for 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.

Inclusion criteria

• 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
• MMSE score of 20-30 and ability to understand and follow instructions during the trial
• Able to sign an informed consent form.

Exclusion criteria

• 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.
• History of severe psychiatric disorders, other neurological diseases, acute cardiopulmonary dysfunction, multiple organ failure, brain tumours, or epilepsy.