A Short Instrumented Test of Mobility for Neurological Disorders

描述(申请人提供)：平衡不良是数百万慢性神经系统疾病患者以及许多老年人死亡和生活质量下降的最常见来源。目前还没有经济有效的便携式系统可以让临床医生客观地量化临床环境中的体位阶跃反应。我们APDM公司的长期目标是将一种最先进的临床系统商业化，使用我们的核心技术：世界上最先进的无线、同步、身体穿戴的惯性传感器Opals(APDM.com)来测量运动障碍。这一阶段应用的目标是确定使用这些传感器开发与跌倒风险相关的非常短的平衡和步态测试的可行性。具体目标是：目标1.开发自动衡量标准的算法，并从仪表式站立和步行测试(ISAW)中得出综合“跌倒风险评分”。目标I的目的是开发和测试1分钟平衡和步态测试的有效性和可靠性，用于帕金森氏病患者。目标二.将ISAW集成到移动实验室系统的专有用户界面中。AIM II的目标是构建一个创新的计算机用户界面，使临床医生能够快速、准确、安全和可靠地测试姿势控制的三个方面：站立时的摇摆：姿势摇摆、预期的姿势调整以及步态和转身期间的动态平衡，测试时间为1分钟。我们将首先为帕金森氏症患者开发活动实验室，因为他们比任何其他神经疾病患者都有更多的跌倒，但我们有信心这个工具将对有任何形式的活动障碍的物理治疗师、临床医生和临床试验人员有用，如多发性硬化症、中风、头部损伤、发育障碍、多感觉障碍、虚弱老年人等。我们的第二阶段应用将确定ISAW测试对未来跌倒的预测效果如何，它对轻度神经疾病的敏感性和特异性，对药物的反应，以及ISAW对更广泛的神经平衡障碍和老年跌倒患者的安全性，为广泛的营销做准备。

DESCRIPTION (provided by applicant): Poor balance is the most common source of mortality and reduced quality of life for the millions of people with chronic, neurological disease as well a many elderly people. No cost-effective, portable system is currently available to allow clinicians to objectively quantify postural stepping responses in a clinical environment. The long-term goal of our company, APDM, is to commercialize a state-of-the-art, clinical system to measure mobility disorders using our core technology: the world's most advanced wireless, synchronized, body-worn inertial sensors, the Opals (APDM.com). The objective of this Phase I application is to determine the feasibility of developing a very short balance and gait test related to fall risk using these sensors. The specific aims are: Aim I. To develop algorithms for automatic metrics and a composite 'Fall Risk score' from the Instrumented Stand and Walk Test (ISAW). The objective of Aim I is to develop and test the validity and reliability of a 1-minute balance and gait test for patients with Parkinson's disease. Aim II. To integrate the ISAW into the proprietary user-interface of the Mobility Lab system. The objective of Aim II is to build an innovative, computer user-interface that allows clinicians to quickly, accurately, safely and reliably test 3 aspects of postural control: sway during stance: postural sway, anticipatory postural adjustments, and dynamic balance during gait and turning in a short, 1-minute test. We will initially develop Mobility Lab for patients with Parkinson's disease because they have more falls than any other neurological disorder, but we are confident that this tool will be useful for physical therapists and clinicians and clinical trialists working with any form of mobility disability, such as multiple sclerosis, stroke, head injury, developmental disorders, multisensory deficits, frail elderly, etc. This Phase I application will determine the feasibility of the ISAW test. Our Phase II application will then determine how well the ISAW test predicts future falls, its sensitivity and specificity to mild neurological disease, responsiveness to medication, and safety of the ISAW for a wider range of neurological balance disorders and elderly fallers, in preparation for widespread marketing.