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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Apr 2025 to Dec 2026
    • Study completion date: Dec 2025 to Sep 2027
    • Secondary endpoints: details revised at 15 of 21 entries
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06780488
Lead Sponsor I.R.C.C.S. Fondazione Santa Lucia
Conditions
(from sponsor)
Stroke
Related terms Stroke
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov