NCT06780488Recruiting
Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 13 Jan 2025
- Start date
- Jan 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Diseases
- Stroke
- NCT number
- NCT06780488
What you commit to
- Study type: Interventional
- Planned participants: 38
- From Jan 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with stroke (less than 6 months from the acute event);
- Epilepsy.
Age
- Patients aged under 18 and over 80;
Other
- 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);
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Santa Lucia IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.