Impact of Immersive Virtual Reality in the Rehabilitation in the Acute Phase of Stroke: a Clinical Study and Correlation With Blood Biomarkers and Polymorphisms Related to Neuroplasticity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Stroke is the leading cause of acquired disability in adults. Neurorehabilitation aims to recover the affected function by stimulating neuroplasticity. Immersive virtual reality (IVR) has shown that it can be effective but the evidence is still weak. Similarly, few studies have analysed blood biomarkers as outcome or predictive indicators, and knowledge of the influence of genetic polymorphisms on rehabilitation efficacy is limited. Our objectives are (1) to demonstrate that the addition of IVR to conventional rehabilitation (CR) improves upper-limb motor function, functional status, and quality of life in stroke patients, at short and long term; (2) to determine the effect of IVR on the expression of neuroplasticity biomarkers at long term; (3) to evaluate the impact of genetic polymorphisms on the rehabilitation and functional prognosis of treated patients, at short and long term; and (4) to identify acute phase predictive biomarkers of motor recovery and functional prognosis at short and long term. To this end, we propose a single-center, prospective, randomised, controlled, and open label clinical trial with blinded end-point assessment. Adults diagnosed of acute ischaemic/haemorrhagic stroke with mobility impaired in the upper-limb and included in a program of intensive CR (ICR) at hospital discharge will be included. Patients will be randomly assigned into two groups: ICR+IVR or only ICR and will be followed for one year to assess, at 3 and 12 months, motor strength in the upper-limb, functional dependence and quality of life. In blood samples obtained at admission (baseline) and at 12 months, proteins and microRNAs will be analysed to identify predictive biomarkers of recovery (motor and functional) and to determine the effect of IVR on neuroplasticity mechanisms. Genetic polymorphisms that may affect motor and functional recovery of patients treated with RC±RVI will also be analysed
详细描述
The study will be conducted as a single-center, prospective, randomized, controlled, open-label clinical trial with blinded endpoint assessment. It aims to evaluate the benefits of neurorehabilitation combining conventional rehabilitation (CR) and immersive virtual reality (IVR) on patients' motor function and functional prognosis, as well as on the expression of blood biomarkers of neuroplasticity and the influence of specific genetic polymorphisms on rehabilitation response.
2. Study population
All patients meeting the following criteria will be included:
Inclusion criteria Diagnosis of ischemic stroke or intracerebral hemorrhage. Age > 18 years. < 7 days between stroke onset and inclusion in the study. Impairment of mobility in the right or left upper limb due to stroke. After hospital discharge, patients continue an intensive conventional rehabilitation (ICR) program at their referral rehabilitation center (MUTUAM).
Ability to understand and sign the study informed consent form (ICF) and the IDIBGI Biobank informed consent form.
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
- •Diagnosis of ischemic stroke or intracerebral hemorrhage. Age > 18 years. < 7 days between stroke onset and inclusion in the study. Impairment of mobility in the right or left upper limb due to stroke. After hospital discharge, patients continue an intensive conventional rehabilitation (ICR) program at their referral rehabilitation center (MUTUAM).
- •Ability to understand and sign the study informed consent form (ICF) and the IDIBGI Biobank informed consent form.
排除标准
- •Previous upper limb disability (neurological or non-neurological cause). Previous dementia or any disease with a life expectancy of less than 1 year. Language comprehension difficulties. Difficulty remembering exercise instructions. History of photosensitive epilepsy.