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

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06780488
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mini-BESTest	T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Performance Oriented Mobility Assessment	T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Modified Barthel Index	T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Stroke Specific Quality of Life Scale	T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
User Satisfaction Evaluation Questionnaire	T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Instrumental Gait Evaluation	T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)	The instrumental motor assessment will be performed using seven wearable inertial sensors (128 Hz, Opal, APDM, Portland, Oregon, USA), which operate with an internal battery and are completely wireless. Each inertial sensor contains a triaxial accelerometer, capable of measuring accelerations along its three axes, which will align with the body axes (antero-posterior, lateral-lateral, cranio-caudal), and a triaxial gyroscope to measure angular velocities around these same axes. The seven wearable sensors will be placed using elastic supports at the level of the lambdoid suture of the skull, trunk, sacrum (L4-L5), tibias, and wrists. Accelerations and angular velocities of the body segments of interest will be measured, and from these, various parameters will be extrapolated both in the time and frequency domains. The motor assessment using inertial sensors will be conducted during the execution of four motor tasks: The 10 Meter Walk Test, The Fukuda Stepping Test, The Figure-of-8 Walk
Instrumental assessment of vestibular function	T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)	The assessment of vestibular function will be performed using the Video Head Impulse Test, vHIT OtosuiteV®, GN Otometrics, Denmark. Data related to the gain of the vestibulo-ocular reflex (VOR) during the Head Impulse Paradigm (HIMP) and the Suppression Head Impulse Paradigm (SHIMP) will be considered.

Trial Locations

Locations (1)

Fondazione Santa Lucia IRCCS; 🇮🇹 Roma, RM, Italy