Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback — IRENE  

Stroke Clinical Trial

Official title: Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Due to Stroke Via Eye-tracking Biofeedback (IRENE Project): a Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests.

Clinical Trial Description

Cerebral stroke is the second cause of death and the third cause of disability worldwide, and the first cause of disability in the elderly. One of the most commonly encountered neuropsychological disorders following a stroke is the unilateral spatial neglect. The estimated prevalence of unilateral spatial neglect after stroke is 30%, with a difference in prevalence between subjects with right (38%) and left (18%) lesions. unilateral spatial neglect constitutes a limit in the progression of the patient's rehabilitation, slows down functional recovery and increases stress and burden on the caregiver. In recent decades there has therefore been an appeal to the use of new technologies for the treatment of unilateral spatial neglect. Among these, virtual reality allows us to overcome some limitations of traditional interventions (reduced ecological validity) and has the advantage of using an artificial environment in the virtual space which allows the execution of tasks that simulate the activities of common life. Furthermore, virtual reality systems offer the opportunity to recreate safe, ecological and personalized 3D environments in which patients must perform specific and controlled actions to achieve a goal. Numerous studies have investigated the effectiveness of training with virtual reality showing that it can improve spatial attention in subjects with unilateral spatial neglect and promote the integration of this ability into daily life activities. To date, the studies available in the literature show that through virtual reality treatment it is possible to find significant improvements in the deficit of unilateral spatial neglect. Specifically, patients undergoing virtual reality training showed an increase in visual perception of the left hemispace and in head movements on the affected side following virtual reality training compared to controls, maintaining the results at the 3-month follow-up. Although encouraging, the data available to date are the result of clinical studies characterized by high heterogeneity, medium methodological value and small sample size. Further investigations are needed to generalize the results. Within virtual environments, performance is measured objectively and the level of difficulty can be adjusted to gradually increase the complexity of the tasks by reducing the support and feedback provided by the therapist. Furthermore, through the immersive virtual reality it is possible to record all the data regarding the actions carried out by the patient within the virtual scenario and this can be used to create performance indices with which to measure, in a quantitative and objective manner, the progress during the rehabilitation process. ;

Related Conditions & MeSH terms

• Neglect, Hemispatial
• Perceptual Disorders
• Stroke

• NCT number: NCT06264713
• Study type: Interventional
• Source: I.R.C.C.S. Fondazione Santa Lucia
• Contact: Valeria Verna, MSc
• Phone: 0651501907
• Email: v.verna@hsantalucia.it
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Completion date: December 1, 2025