A Short Instrumented Test of Mobility for Neurological Disorders

描述（由申请人提供）：对于数以百万计的慢性神经疾病患者以及许多老年人来说，平衡能力差是导致死亡和生活质量下降的最常见原因。目前还没有成本效益高的便携式系统可以让临床医生在临床环境中客观地量化体位踏步反应。我们公司APDM的长期目标是将一种最先进的临床系统商业化，该系统使用我们的核心技术：世界上最先进的无线、同步、穿戴式惯性传感器Opals （APDM.com）。第一阶段应用的目的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 .开发自动度量算法和仪表站立和行走测试（ISAW）的综合“跌倒风险评分”。Aim I的目标是开发和测试帕金森病患者1分钟平衡和步态测试的有效性和可靠性。目的二世。将ISAW集成到移动实验室系统的专有用户界面中。Aim II的目标是建立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、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、步态和转身时的动态平衡，只需1分钟的测试。我们最初将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系统疾病都更容易跌倒，但我们相信，这个工具将对物理治疗师、临床医生和临床试验人员有用，他们可以治疗任何形式的活动障碍，如多发性硬化症、中风、头部损伤、发育障碍、多感觉缺陷、体弱多病的老年人等。第一阶段的应用将决定ISAW测试的可行性。我们的II期申请将确定ISAW测试预测未来跌倒的效果，其对轻度神经系统疾病的敏感性和特异性，对药物的反应性，以及ISAW对更广泛的神经平衡障碍和老年跌倒者的安全性，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.