Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264713
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-09
Brief Title:
Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback
Sponsor:
IRCCS Fondazione Santa Lucia
Organization:
IRCCS Fondazione Santa Lucia
Study Overview
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
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IRENE
Brief 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
Detailed 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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None