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

I.R.C.C.S. Fondazione Santa Lucia

Status

Enrolling

Conditions

Stroke

Treatments

Other: Real Visual-Vestibuar Rehabilitation

Other: Sham Rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06780488

171/SL/23

Details and patient eligibility

About

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.

Enrollment

38 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.