Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors

This pilot study aims to evaluate the effect of a specfic Virtual-Reality-Based rehabilitation training in patients with stroke. A total of 38 patients with stroke (more than 6 months from the acute event), recruited from the services of the Fondazione Santa Lucia IRCCS in Rome, will be included in the present study. Participants will be randomized into two groups: a Real group and a Sham group. Both groups will undergo a rehabilitation intervention using an immersive virtual reality system. The Real group will be exposed to scenarios containing specific stimuli for the visuo-vestibular system, while the Sham group will be exposed to the same scenarios but without specific stimuli. All participants in both groups will undergo 12 treatment sessions (three times a week), each lasting 20 minutes. All treatments will be conducted by physiotherapists specialized in neurological and vestibular rehabilitation. Patients will be assessed before the start of the treatment, at the end of the intervention, and one month after its completion, in order to evaluate the effects of the experimental training on balance and gait, and on the patient's perceived quality of life. Another aim will be to assess the user's satisfaction with the new proposed protocol.

NCT Number	NCT06780488
Lead Sponsor	I.R.C.C.S. Fondazione Santa Lucia
Conditions	Stroke
Enrollment	38 participants
Start Date	2025-01-01
Primary Completion	2026-12 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-01-23