NCT06780488 Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
| NCT ID | NCT06780488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Subjects with a history of hemorrhagic or ischemic stroke (more than 6 months from the acute event) * Patients aged between 18 and 80 years * Absence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation \> 24) * Functional Ambulation Category ≥ 3 * Absence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study Exclusion Criteria: * Patients with stroke (less than 6 months from the acute event); * Patients aged under 18 and over 80; * Presence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study; * Presence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation ≤ 24); * Epilepsy.
Contact & Investigator
Jacopo Piermaria
PRINCIPAL INVESTIGATOR
Fondazione Santa Lucia IRCCS
Frequently Asked Questions
Who can join the NCT06780488 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06780488 currently recruiting?
Yes, NCT06780488 is actively recruiting participants. Contact the research team at s.deangelis@hasantalucia.it for enrollment information.
Where is the NCT06780488 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06780488 clinical trial?
NCT06780488 is sponsored by I.R.C.C.S. Fondazione Santa Lucia. The principal investigator is Jacopo Piermaria at Fondazione Santa Lucia IRCCS. The trial plans to enroll 38 participants.
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