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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione Santa Lucia IRCCS
RECRUITING
Roma
Contact Information
Primary
Sara De Angelis, MSc
s.deangelis@hasantalucia.it
00390651501772
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 38
Treatments
Experimental: Real
Sham_comparator: Control
Related Therapeutic Areas
Sponsors
Leads: I.R.C.C.S. Fondazione Santa Lucia

This content was sourced from clinicaltrials.gov