What is the problem to be addressed?
Stroke represents a leading cause of global disability and the estimated annual cost for new stroke cases in Spain is 1989 millions €. The number of stroke survivors is increasing annually representing a heavy burden for health care systems worldwide. Most stroke survivors suffer from hemiparesis, and often present substantial motor control deficits of the upper- and lower extremities, including balance and walking problems. Many stroke patients also present cognitive dysfunction and have difficulties to undertake rhythmic and sequential movements. All the aforementioned issues result in substantial disability and a significantly reduced quality of life. Virtual reality (VR) technology is an effective tool for treatment and rehabilitation purposes in patients with chronic diseases, but its implementation in stroke patients has been poorly applied. Nowadays, practitioners lack a gamified, fully immersive, and stroke-specific VR software which integrates the ultimate scientific evidence. Developing a VR software with these features will pave the way for improving disability and quality of life in stroke patients.
What is the proposal?
The aims of this proposal are:
Aim 1: how will the software be developed?
The RESET VR software will be developed by a multidisciplinary group including 2 teams of computer engineers, stroke specialists and, importantly, with patient involvement. The software will include 10 therapeutic modules designed to address 10 areas of stroke-related disability. The development will be an iterative process including three main phases (pre-production, production, and post-production). The pre-production comprises multidisciplinary decision making and testing of ‘demo versions’ by patients. The production consists of actually producing the previously agreed modules using the SCRUM methodology (a structured framework for agile software development). The post-production consists of fixing bugs, software optimization, and promotion. The entire development period will last approximately 18 months, and the remaining 18 months will be used to carry out the aim 2.
Aim 2: how will the software be validated?
A multicenter randomized clinical trial will be conducted in two Andalusian cities (Almería and Granada). A total of 94 men and women with incident stroke will be recruited and randomly allocated to (i) usual care, (ii) usual care + VR using a commercial gaming system, or (iii) usual care + RESET VR software. The intervention will last 10 weeks starting at week 3 after the stroke event. The primary outcome will be disability (assessed with the Barthel index), that will be assessed at baseline (week 2 after stroke), week 13, and week 26. Secondary outcomes include quality of life, upper-body motor function, gross manual dexterity, handgrip strength, static and dynamic balance, and cognitive function. Adherence to the intervention, adverse events, and patient satisfaction will be registered.
What are the expected results?
The RESET VR software, in combination with usual care rehabilitation, will improve functional disability and quality of life further than usual care rehabilitation alone or combined with commercial gaming systems. We expect the software to be at RL7 stage of technological development (i.e., the system or prototype has been tested in a real-world environment) at the end of the project. The software will be registered under an intellectual property license and has the potential to be acquired and implemented by both national and international health care systems.
This project is funded by the Spanish ministry of science and innovation (CPP2021-008497)
Currently under preparation/revision.
Not yet available.
