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

项目概要/摘要 凝视和姿势稳定性的缺陷与前庭功能减退密切相关。这些缺陷导致 头晕和平衡不良，增加福尔斯和其他不良健康结果的风险。前庭 功能减退在几种情况下发生，并且随着年龄的增长而越来越普遍。估计 85%的80岁以上的人经历前庭功能减退。与许多与年龄有关的健康问题一样， 挑战（如肌肉减少症，骨质疏松症，心血管疾病），运动被广泛推荐， 修复前庭功能减退的影响。前庭康复已被证明有效， 在严格对照的临床试验中改善前庭功能减退，但在实践中的有效性有限 两个主要障碍：1）减少患者对锻炼计划的依从性，2）无法精确地 评估前庭功能。这些是重叠的挑战;缺乏前庭功能 评估阻碍了康复的有效剂量以及对患者依从性的监测， 中求进工作总因此，个性化和监测-几乎任何健康或运动的基本成分 方案-在前庭康复实践中功能缺失。 对于这个建议，我们已经开发了在凝视和姿势稳定性中做出信息决定 （MINDGAPS）系统，该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依从性。此外，本发明还 MINDGAPS利用美国国立卫生研究院的数据来显示患者的状态与标准值相比， 指示相对于测量误差随时间推移的进展。这使得两个创新的应用 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 2）经常监测进展和结果。本研究旨在研究 MINDGAPS系统的初步功效沿着使用的可行性、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例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周的个体化前庭功能测试。 通过MINDGAPS系统提供康复信息。干预措施的初步效果将由 将干预阶段的计算机化动态视力（cDVA）评分与 在基线阶段。其他临床结局（例如，姿势稳定性，视频头脉冲测试，病人 报告的头晕）也将进行检查。将检查干预的可行性和安全性， 招募、保留和依从率的先验阈值，以及不良事件的记录。 最后，将使用混合方法探索系统的可接受性和远程/远程保健能力 分析，这将为将来的R 01提交（II期临床试验）的准备工作提供系统改进信息。

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).