The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The absence of severe adverse reactions
研究概览
简要总结
The aim of the study is to determine virtual reality (VR) impact during standard program of rehabilitation on emotional state of patients with aphasia.
详细描述
Aim 1: To test the safety of virtual reality in a vulnerable population of patients with aphasia during rehabilitation. Participants will be alternately assigned to receiving a relaxation session in VR every working day during a standard course of rehabilitation.
Aim 2: To test the preliminary efficacy of combining VR with the course of rehabilitation to promote emotional improvements in patients with aphasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild or moderate aphasia of any type
- •Russian is primary language
- •At least 2 weeks post cardio-vascular accident (ischemic or hemorrhagic stroke) or head injury of any location
- •Have a history of only one stroke
- •Medically stable
排除标准
- •Associated severe cognitive deficits and psychiatric disorders which prevent patients understanding of the informed consent
- •Medical history of severe visual or hearing impairment
- •Comorbid neurological diagnosis (e.g. epilepsy, multiple sclerosis, Parkinson disease, dementia)
- •Unable to perform the required exercises due to severe motor, sensory or cognitive deficit (memory, attention, executive functioning, apraxia, regulatory and planning activities etc.) and medical problems (for example, anyone meeting New York Heart Association Class IV criteria, hospitalization for myocardial infarction or heart surgery within 120 days, severe cardiomyopathy or documented serious and unstable cardiac arrhythmias)
- •Drug or alcohol addiction within the last 6 months.
- •Significant current psychiatric illness defined as affective disorder unresponsive to medication or bipolar affective disorder, psychosis, schizophrenia or suicidality
- •Current participation in another interventional trial
结局指标
主要结局
The absence of severe adverse reactions
时间窗: From admission to discharge, up to 3 weeks
Assessed by a self-reported form and physiological parameters
次要结局
- Visual Analog Mood Scale (VAMS)(From admission to discharge, up to 3 weeks)
- Three-level European quality of life five-dimensional questionnaire(From admission to discharge, up to 3 weeks)
- 10 - Stroke Aphasic Depression Questionnaire (SADQH-10)(From admission to discharge, up to 3 weeks)
- Perceived Stress Scale (PSS)(From admission to discharge, up to 3 weeks)
- Lüscher Color Test(From admission to discharge, up to 3 weeks)
- Aphasic Depression Rating Scale (ADRS)(From admission to discharge, up to 3 weeks)
研究者
Eduard Novak
MD, MSc
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia