Viewing Study NCT06132399



Ignite Creation Date: 2024-05-06 @ 7:48 PM
Last Modification Date: 2024-10-26 @ 3:13 PM
Study NCT ID: NCT06132399
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-17
First Post: 2023-10-26

Brief Title: Virtual Reality Software for Patients With Stroke
Sponsor: Universidad de Almeria
Organization: Universidad de Almeria

Study Overview

Official Title: Development and Validation of a Novel Virtual Reality Software for Improving Disability and Quality of Life in Patients With Stroke
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
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: RESET
Brief Summary: The goal os this clinical trial is to develop and validate a gamified fully immersive and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke

The main questions it aims to answer are

To assess the effects of a gamified fully immersive and stroke-specific virtual reality 10-week intervention combined with usual care rehabilitation compared to usual care rehabilitation alone and in combination with a commercially available VR system on disability in patients with stroke
To assess the effects of a gamified fully immersive and stroke-specific virtual reality intervention combined with usual care rehabilitation compared to usual care rehabilitation alone and in combination with a commercially available virtual reality system on quality of life upper-body motor function gross manual dexterity handgrip strength static and dynamic balance and cognitive function in patients with stroke
Detailed Description: Stroke is the leading cause of long-term disability and ranks as the second most prevalent cause of mortality worldwide According to data from the World Health Organization since 2005 the global probability of a person experiencing a stroke has increased by 50 percent It is expected that 1 in 4 individuals will face the risk of having a stroke in their lifetime A stroke can result in significant loss of motor functions communications abilities weakness or hemiparesis leading to a diminished quality of life Therefore improving the rehabilitation process is evidently of paramount significance Virtual reality has emerged as a novel strategy to improve neurological diseases however there is an absence of an immersive software designed specifically for stroke patients within a gamified environment Therefore the aim of RESET randomized controlled trial is to evaluate the effect of a gamified fully immersive and stroke-specific virtual reality software on disability in stroke patients

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