Development and Validation of a Novel Virtual Reality Software for Improving Disability and Quality of Life in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Disability (The Barthel index)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men with either an ischemic or hemorrhagic stroke
- •Stroke between the last 7 to 14 days
- •Functional independence before stroke (modified Rankin scale <3)
- •Paresis of the lower extremity, upper extremity, or both, with a score ≤3 on the "motor arm" item of the National Institutes of Health Stroke Scale (NIHSS) scale
- •Trunk control in seated and standing position
- •Ability to understand basic instructions and to decide whether to sign informed consent
排除标准
- •Moderate-severe aphasia that precludes understanding the required tasks
- •Cognitive impairment that precludes cooperation with tasks
- •Serious behavioral problems or mental disorders
- •Lower extremity deep vein thrombosis, quadriplegia, neurodegenerative diseases, lower limb fractures, or recent myocardial infarction
- •Vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, or other unstable condition
- •A history of cerebrovascular disease (if not fully resolved)
- •Photosensitive epilepsy
研究组 & 干预措施
Commercial non-immersive virtual reality group (CVR)
Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan).
干预措施: Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) (Device)
Gamified, fully immersive and stroke-specific virtual reality group (RESET)
The RESET virtual reality software will be integrated in the META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US).
干预措施: META QUEST 3 virtual reality glasses (Device)
Usual care (UC)
3 session/week of 90 minutes of physical therapy and occupational therapy.
干预措施: Usual care (Other)
结局指标
主要结局
Disability (The Barthel index)
时间窗: Changes from baseline to weeks 13 and 26
An ordinal scale used to measure performance in activities of daily living. It consists of 10 common activities, with eight of them representing activities related to personal care and 2 related to mobility. These are assessed for independence/dependence and scored via an arbitrary weighting system- the index yields a total score out of 100 - the higher the score, the lower degree of disability.
次要结局
- Handgrip strength(Changes from baseline to weeks 13 and 26)
- Lower extremity function (Berg Balance Scale)(Changes from baseline to weeks 13 and 26)
- Lower extremity function (Time Up and Go test)(Changes from baseline to weeks 13 and 26)
- Plasma concentrations of inflammatory markers(Changes from baseline to weeks 13 and 26)
- BDNF quantification in blood(Changes from baseline to weeks 13 and 26)
- GDNF quantification in blood(Changes from baseline to weeks 13 and 26)
- PACAP-38 quantification in blood(Changes from baseline to weeks 13 and 26)
- Plasma concentrations of inflammatory markers, quantification in blood(Changes from baseline to weeks 13 and 26)
- IGF-1 quantification in blood(Changes from baseline to weeks 13 and 26)
- NGF quantification in blood(Changes from baseline to weeks 13 and 26)
- Cognitive function(Changes from baseline to weeks 13 and 26)
- Quality of life (NEWSQOL)(Changes from baseline to weeks 13 and 26)
- Gross manual dexterity (The Box and Block Test)(Changes from baseline to weeks 13 and 26)
- Upper extremity motor function (Fugl-Meyer assessment of Upper Extremity)(Changes from baseline to weeks 13 and 26)
研究者
Alberto Soriano-Maldonado
PhD
Universidad de Almeria