NCT06275516

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: First Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	multi-sensory stimulation immersive VR+ treadmill training	Treadmill training with multi-sensory stimulation immersive VR in VR+treadmill training group
DEVICE	treadmill training	Only treadmill training in treadmill training group

Timeline

• Start date: 2024-03-20
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2024-02-23
• Last updated: 2026-03-19

Locations

1 site across 1 country: China