Making INformed Decisions in Gaze and Postural Stability (MINDGAPS): a Novel System for Improving Personalized Care and Patient Adherence in Vestibular Rehabilitation

项目摘要/摘要 凝视和姿势稳定性的缺陷与前庭功能减退密切相关。这些赤字导致了 头晕和平衡不良，增加摔倒和其他不良健康后果的风险。前庭 功能减退会在几种情况下发生，并随着年龄的增长而变得越来越普遍。据估计 85%的80岁以上的人经历了前庭功能减退。与许多与年龄相关的健康状况一样 挑战(如骨质疏松症、心血管疾病)，运动被广泛推荐给 纠正前庭功能减退的影响。前庭康复已显示出疗效 在严格控制的临床试验中改善前庭功能低下，但在实践中的有效性有限 两个主要障碍：1)降低了患者对锻炼计划的依从性，2)无法准确地 评估前庭功能。这些都是相互重叠的挑战；无法获得前庭功能 评估妨碍了康复的有效剂量以及对患者依从性的监测 进步。因此，个性化和监控--几乎任何健康或锻炼的基本要素 治疗方案-在前庭康复实践中功能缺失。 对于这一建议，我们开发了凝视和姿势稳定性中的明智决策 (MINDGAPS)系统，利用可穿戴传感器技术提供简单、精确的凝视测量 和姿势稳定性，以及远程监测患者对前庭锻炼的坚持情况。另外， MINDGAPS利用NIH工具箱数据显示与标准值相比的患者状态，并 指示相对于测量误差随时间推移的进度。这使得两个创新的应用成为可能 旨在促进患者依从性的行为科学原则：1)社会规范；患者的比较 对她或他的同龄人，2)经常监测进展和结果。这项研究旨在检查 MINDGAPS系统的初步效果及其使用的可行性、安全性和可接受性 在实践中。我们将采用单队列、双基线设计(n=30名患有前庭功能减退的老年人)。 在基线(对照)阶段之后，所有参与者将完成6周的个性化前庭 由MINDGAPS系统提供信息的康复。将通过以下方式检查干预的初步效果 干预阶段计算机动态视力(CDVA)评分与cDVA评分的比较 在基线阶段。其他临床结果(例如，姿势稳定性、视频头脉冲测试、患者 报告的头晕)也将被检查。干预的可行性和安全性将根据以下方面进行检查 招募、保留和依从率的先验阈值，以及不良事件的记录。 最后，将使用混合方法来探索该系统的可接受性和远程/远程保健能力 分析，这将为系统改进提供信息，为未来的R01提交(第二阶段临床试验)做准备。

PROJECT SUMMARY/ABSTRACT Deficits in gaze and postural stability are closely linked with vestibular hypofunction. These deficits result in dizziness and poor balance, increasing the risk for falls and other poor health outcomes. Vestibular hypofunction occurs with several conditions and is increasingly prevelant with advancing age. An estimated 85% of people over the age of 80 experience vestibular hypofunction. As with many age-related health challenges (e.g. sarcopenia, osteoporosis, cardiovascular disease), exercise is widely recommended to remediate the effects of vestibular hypofunction. Vestibular rehabilitation has demonstrated efficacy at improving vestibular hypofunction in tightly controlled clinical trials, but the effectiveness in practice is limited by two major barriers: 1) reduced patient adherence to the exercise program, and 2) inability to precisely assess vestibular function. These are overlapping challenges; lack of access to vestibular function assessments impedes effective dosing of rehabilitation as well as monitoring of patient adherence and progress. Thus, personalization and monitoring—essential ingredients of nearly any health or exercise regimen—are functionally missing in vestibular rehabilitation practice. For this proposal, we have developed the Making INformed Decisions in Gaze and Postural Stability (MINDGAPS) system, which utilizes wearable sensor technology to provide simple, precise measures of gaze and postural stability, as well as remote monitoring of patient adherence to vestibular exercises. Additionally, MINDGAPS leverages NIH Toolbox data to display patient status compared to normative values and to indicate progress over time relative to measurement error. This enables the application of two innovative behavioral science principles aimed at facilitating patient adherence: 1) social norming; comparison of a patient to her or his peers, and 2) frequent monitoring of progress and outcomes. This study is designed to examine the preliminary efficacy of the MINDGAPS system, along with the feasibility, safety, and acceptability of its use in practice. We will use a single cohort, double-basline design (n=30 older adults with vestibular hypofunction). Following, the baseline (control) phase, all participants will complete 6 weeks of individualized vestibular rehabilitation informed by the MINDGAPS system. Preliminary efficacy of the intervention will be examined by comparing computerized Dynamic Visual Acuity (cDVA) scores during the intervention phase to cDVA scores during the baseline phase. Other clinical outcomes (e.g., postural stability, video-head impulse testing, patient reported dizziness) will also be examined. Feasibility and safety of the intervention will be examined relative to a priori thresholds for recruitment, retention and adherence rates, as well as recording of adverse events. Finally, the acceptability and remote/telehealth capability of the system will be explored using a mixed methods analysis, which will inform system refinement in preparation for a future R01 submission (phase II clinical trial).