Immersive Virtual Reality to Improve Outcomes in Patients with Stroke: A Pilot Study

沉浸式虚拟现实改善中风患者的治疗效果：一项试点研究

• 批准号: 10311097
• 负责人: Johanna E. Tran
• 金额: --
• 依托单位: JAMES A. HALEY VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10311097
• 关键词: 3-Dimensional; 3D virtual reality; Action Research; Address; Adverse event; Area; Beds; Brain; Caring; Chronic; Clinic; Clinical; Cognitive; Computers; Data; Effectiveness; Enrollment; Environment; Exercise; Goals; Goggles; Hand; Head and neck structure; Health Services Accessibility; Home; Immersion; Inpatients; Intervention; Knowledge; Leg; Literature; Measures; Methodology; Modality; Modernization; Motor; Movement; Multi-Institutional Clinical Trial; Music; Nature; Outcome; Outcome Measure; Pain; Pain Research; Patients; Patients' Rooms; Persons; Physical Medicine; Physical Rehabilitation; Pilot Projects; Play; Policy Maker; Population; Published Comment; Qualitative Methods; Questionnaires; Randomized Controlled Trials; Recovery; Recovery of Function; Rehabilitation therapy; Reporting; Research; Research Design; Sample Size; Schedule; Sensory; Stroke; Surveys; Target Populations; Technology; Testing; Therapeutic; Therapeutic Uses; Time; Translating; Upper Extremity; Use Effectiveness; User-Computer Interface; Veterans; Veterans Health Administration; Veterans Hospitals; Video Games; Vision; Work; acute stroke; arm; base; clinical efficacy; cognitive load; cognitive modulation of pain; dexterity; distraction; dosage; effectiveness evaluation; efficacy testing; experience; head mounted display; impression; improved; improved outcome; innovation; interest; meetings; military veteran; motor recovery; movement practice; neurological recovery; pain outcome; pain reduction; pilot test; portability; post stroke; primary outcome; programs; prospective; psychologic; rehabilitation research; response; simulation; sound; statistics; stroke patient; stroke rehabilitation; stroke therapy; therapy design; traditional therapy; treatment as usual; two-dimensional; virtual; virtual environment; virtual patient; virtual reality; virtual reality environment; virtual reality intervention

Background. Over the last decade, Virtual Reality (VR) has emerged as a cutting-edge technology in stroke rehabilitation. VR is defined as a type of user-computer interface that implements real-time simulation of an activity or environment allowing user interaction via multiple sensory modalities. VR interventions in a stroke population have been shown to be equivalent to usual care therapies and to enhance motor recovery when utilized as an adjunct. Significance/Impact/Innovation. This research will advance knowledge in rehabilitation research by testing state-of-the-art immersive 3-dimensional VR technology with the post-acute stroke Veteran population. The proposed project addresses: (1) the RR&D goal of maximizing functional recovery, (2) interest in non-pharmacological activity-based interventions for pain, and (3) supports modernization of the Veterans’ Health Administration by incorporating technology- assisted rehabilitation. Specific Aims. (1) Determine the feasibility and tolerability of using a therapeutic VR platform in an inpatient comprehensive stroke rehabilitation program and (2) Estimate the initial clinical efficacy, or effect size, associated with the VR platform using APPS for distraction and upper extremity exercise for Veterans post-stroke. Methodology. Prospective within-subject pre-post pilot and survey study designs will be used. The target populations are (1) clinical staff who work on the Comprehensive Interdisciplinary Inpatient Rehabilitation Program (CIIRP) at the James A. Haley Veterans’ Hospital (JAHVH) in Tampa (sample size N=10) and Veterans who are inpatients in the CIIRP (sample size N=10). The VR intervention consists of wearing a head mounted display that plays APPs ranging from music and nature views for pain distraction to more challenging strengthening and coordination activities such as playing the piano virtually. The intervention will last four weeks. The analytic approach will use descriptive statistics and qualitative methods. Aim 1 will administer a survey with open and closed ended questions to clinicians to examine the feasibility of successfully integrating a VR intervention into the flow of usual care. Feasibility constructs include adaptability (can VR intervention be adapted to an inpatient unit), patient need (do Veterans like and benefit from the intervention), and staff comments/impressions. Responses for each construct will be entered into an excel spreadsheet, one tab for each construct. Responses will then be grouped by similar content. Results will be reported as themes and subthemes. Aim 1 will also track patient VR tolerability by documenting and discussing patient complaints and adverse events. Tolerability data will be extracted from meeting minutes and grouped by similar occurrences. Results will be reported as themes and subthemes. Aim 2 will estimate effect sizes and degree of precision for upper extremity neurologic recovery, hand dexterity, and pain outcomes measured pre and post VR intervention. Neurologic recovery is measured with the Fugl-Meyer Assessment of Motor Recovery after Stroke-Upper Extremity, dexterity is measured with the Action Research Arm Test, and pain is measured with the Pain Outcomes Questionnaire-VA. Because standard scores do not necessarily translate to meaningful clinical differences (improvements), we will identify the proportion of subjects who experience the minimal clinically important difference (MCID). Metrics will also be compared across outcomes. Next Steps/Implementation. Our next step is to work with our Program Partner in the Physical Medicine and Rehabilitation Office to conduct a large multi-site clinical trial that will incorporate the lessons learned from this feasibility pilot study to test the efficacy of a VR intervention in inpatient rehabilitation and transition to home evironments.

背景在过去的十年里，虚拟现实（VR）已成为一项前沿技术， 中风康复VR被定义为一种用户-计算机界面， 模拟活动或环境，允许用户通过多种感官形式进行交互。VR 在中风人群中的干预已被证明等同于常规护理治疗， 当用作辅助时，增强运动恢复。影响力/影响力/创新。这项研究将 通过测试最先进的沉浸式三维虚拟现实技术，提高康复研究的知识水平 急性中风后退伍军人群体的技术。拟议的项目涉及：（1）经常资源和发展 功能恢复最大化的目标，（2）对非药理学活动为基础的干预措施的兴趣， 疼痛，和（3）支持退伍军人健康管理局的现代化，结合技术- 协助康复。 具体目标。(1)确定在治疗性VR平台中使用的可行性和耐受性。 脑卒中住院患者综合康复方案;（2）评估初步临床疗效或效果 尺寸，与使用APPS进行牵引和上肢锻炼的VR平台相关， 中风后的退伍军人。 方法论将使用前瞻性受试者内试验前和试验后研究设计。的 目标人群是（1）从事综合性跨学科住院治疗的临床工作人员 康复计划（CIRP）在詹姆斯A。坦帕的Haley退伍军人医院（JAHVH）（样本量 N=10）和CIRP中的住院患者退伍军人（样本量N=10）。VR干预包括 戴着头戴式显示器，播放从音乐到自然景观的应用程序，以分散疼痛 到更具有挑战性的加强和协调活动，如弹钢琴虚拟。的 干预将持续四周。分析方法将使用描述性统计和定性 方法.目标1将管理一项调查，包括开放式和封闭式问题，供临床医生检查 将VR干预成功整合到日常护理流程中的可行性。可行性结构 包括适应性（VR干预是否适合住院单位）、患者需求（退伍军人喜欢 并从干预中受益）以及工作人员的评论/印象。每个结构的响应将是 输入到Excel电子表格中，每个构件一个选项卡。然后将响应按类似的 内容结果将作为主题和次主题报告。目标1还将通过以下方式跟踪患者VR耐受性： 记录并讨论患者投诉和不良事件。将提取耐受性数据 并按类似事件分组。结果将作为主题报告， 次主题目标2将估计上肢神经功能的效应量和精确度 恢复、手灵活性和VR干预前后测量的疼痛结果。神经功能恢复 用Fugl-Meyer中风后运动恢复评估-上肢灵活性、灵巧性 用行动研究手臂测试测量，疼痛用疼痛结局测量 弗吉尼亚州，因为标准评分不一定能转化为有意义的临床差异 （改善），我们将确定发生最小临床重要 差异（MCID）。还将比较不同结局的风险。 后续步骤/实施。我们的下一步是与我们的计划合作伙伴在物理医学 和康复办公室进行一项大型多地点临床试验， 从这项可行性试点研究，以测试VR干预在住院康复中的疗效， 过渡到家庭设备。