IVR ON UPPER-LIMB REHABILITATION IN STROKE PATIENTS: A CLINICAL TRIAL (REVICTUS)
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
研究概览
详细说明
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.
Patients eligible for participation in the study will be those admitted to the Stroke Unit of Dr. Josep Trueta University Hospital (HUJT) with a diagnosis of ischemic stroke or intracerebral hemorrhage. Following clinical stabilization, and always within the first seven days after stroke onset, inclusion and exclusion criteria will be reviewed. Patients and their relatives will be informed about the study and will sign the informed consent forms (study and biobank). Patients will then be randomly assigned to one of the two study groups in a 1:1 ratio using a web-based platform and will be assigned an identification number for pseudonymization purposes.
The study groups will be:
Control group (CR): patients who will receive conventional rehabilitation (CR) in our hospital followed by an intensive conventional rehabilitation (ICR) program at the rehabilitation center.
Intervention group (CR+IVR): patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yolanda Silva, MD PhD
- 电话号码：34972940262
- 邮箱：ysilva.girona.ics@gencat.cat
学习地点
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Girona、西班牙
- 招聘中
- Hospital Dr Josep Trueta
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接触：
- Yolanda Silva, MD PhD
- 电话号码：34972940262
- 邮箱：neurologia.girona.ics@gencat.cat
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副研究员：
- Mikel Terceño, MD PhD
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副研究员：
- Elisvan Rufino
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副研究员：
- Nuria Bas
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副研究员：
- Imma Boada
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副研究员：
- Elisabet Ortiz
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副研究员：
- Carme Gubern
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
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Exclusion Criteria:
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.
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学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control Group
Control group (CR): patients who will receive conventional rehabilitation (CR) in our hospital followed by an intensive conventional rehabilitation (ICR) program at the rehabilitation center.
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有源比较器：IVR group
Intervention group (CR+IVR): patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
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patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Motor Function
大体时间：at 3 and 12 months
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NIHSS assessment of arm function
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at 3 and 12 months
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Quality of life of patients
大体时间：3 and 12 months
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ECVI-38
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3 and 12 months
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Functional outcome
大体时间：3 and 12 months
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modified Rankin scale
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3 and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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FAC
大体时间：3 and 12 months
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Assessment of FAC
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3 and 12 months
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Fugl-Meyer
大体时间：3 and 12 months
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Fugl-Meyer Assessment
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3 and 12 months
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BBT
大体时间：3 and 12 months
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Assessment of BBT (Box and Block Test)
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3 and 12 months
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9HPT
大体时间：3 and 12 months
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Assessment of 9HPT (Nine-Hole Peg Test)
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3 and 12 months
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Safety measure
大体时间：3 months
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Adverse events
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3 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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