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Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients.

Stroke Clinical Trial

Official title:
A Single-blind Randomized Controlled Trial of Multisensory Stimulation Virtual Reality to Improve Motor and Cognitive Function in Stroke Patients

Clinical Trial Summary

This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06275516
Study type Interventional
Source First Affiliated Hospital of Chongqing Medical University
Contact Dingqun Bai
Phone 023-89011334
Email baidingqun2014@163.com
Status Not yet recruiting
Phase N/A
Start date February 20, 2024
Completion date September 20, 2024
View Details
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