A Short Instrumented Test of Mobility for Neurological Disorders

神经系统疾病流动性的简短仪器测试

• 批准号: 8705232
• 负责人: Mahmoud El-Gohary
• 金额: $ 51.32万
• 依托单位: APDM, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8705232
• 关键词: Admission activity; Age; Aging; Assisted Living Facilities; Athletic; Biological Markers; Cessation of life; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Communities; Complex; Computer software; Consensus; Data; Data Collection; Databases; Elderly; Elderly man; Equilibrium; Evaluation; Fall prevention; Gait; Gait abnormality; Goals; Hospitals; Human; Injury; Laboratories; Laboratory Study; Levodopa; Link; Longitudinal Studies; Marketing; Measures; Metric; Monitor; Motion; Movement; Movement Disorders; Neurologist; Nursing Homes; Oregon; Parkinson Disease; Patients; Penetration; Performance; Phase; Primary Care Physician; Protocols documentation; Recurrence; Reference Values; Rehabilitation therapy; Reporting; Research; Research Personnel; Severities; Severity of illness; Site; Small Business Technology Transfer Research; Step Tests; System; Technology; Testing; Visit; Walking; Woman; age related; base; clinical practice; disability; equilibration disorder; fall risk; falls; instrument; interest; kinematics; men; nervous system disorder; novel; older men; older women; osteoporosis with pathological fracture; prospective; public health relevance; sensor; technology development

DESCRIPTION (provided by applicant): APDM is a young company focused on developing and commercializing professional systems using wearable inertial sensors for monitoring of human movement and movement disorders. In Phase I, we developed the novel, Instrumented Stand and Walk test (ISAW) using APDM's proprietary, Opal movement monitors and Mobility Lab system. We validated the ISAW by demonstrating that the ISAW measures were sensitive to severity of Parkinson's disease (PD) and levodopa treatment. The ISAW allows clinicians and nonexperts to quickly obtain objective measures of standing balance, step-initiation, gait, and turning. The ultimate goal for the product is to provide a quick, portable, clinical system to quickly and automatically obtain objective measures of balance and gait disorders to predict fall risk using body-worn sensors. This Phase II STTR proposal will expand the use of the ISAW from PD to elderly fallers. We will partner with the largest, longitudinal study of falls in elderl men, the Osteoporotic Fractures in Men Study (MrOS), to characterize balance and gait in 361 community-dwelling older men, and with the Oregon Center of Aging and Technology (ORCATECH) in 97 community-dwelling older women. This proposal will not only demonstrate the feasibility and usefulness of the ISAW to quickly quantify balance and gait for multicenter clinical trials, it will also develop a unique Fall Risk Report and provide the ISAW with normative values for the elderly. This 3-year study will have both a Clinical Research and a Technology Development Aim to prepare the ISAW to expand market penetration from research to clinical practice as an objective biomarker for fall risk and mobility disability. The impact of the ISAW wil be on clinicians interested in measuring fall risk in the elderly, including primary care physician, neurologists, geriatricians, rehabilitation professionals, assisted living facilities, hospitals an athletic trainers. The Specific Aims are: Aim I. Clinical Research: Develop a fall risk evaluation system for clinicians from the ISAW test (Milestone 1. Develop a Fall Risk Report and Milestone 2. Develop reference values for integrity of balance and gait across older ages). Aim II. Technology Development: Prepare the ISAW to be practical and attractive for clinical practice as well as clinical trials (Milestone 3. Mobility Exchange: Prepare data repository for multi-site clinical data collection from the ISAW test (Milestone 4. Mobility Clinic: Simplify user-interface and reporting for clinicians, and Milestone 5. FDA: Put quality systems and regulatory compliance in place so ISAW can be marketed for clinical practice). This Phase II proposal will transform APDM's ISAW protocol into the first technological system for clinicians (Mobility Clinic) and clinical researchers (Mobility Lab) to provide a validated, objective fall risk evaluation, as well as comprehensive balance and gait disorder assessment.

描述（由申请人提供）：APDM 是一家年轻的公司，专注于开发和商业化使用可穿戴惯性传感器监测人体运动和运动障碍的专业系统。在第一阶段，我们使用 APDM 专有的 Opal 运动监视器和移动实验室系统开发了新颖的仪表化站立和行走测试 (ISAW)。我们通过证明 ISAW 测量对帕金森病 (PD) 和左旋多巴治疗的严重程度敏感来验证 ISAW。 ISAW 使临床医生和非专家能够快速获得站立平衡、迈步启动、步态和转身的客观测量值。该产品的最终目标是提供一个快速、便携式的临床系统，以快速、自动地获得平衡和步态障碍的客观测量结果，从而使用穿戴式传感器预测跌倒风险。第二阶段 STTR 提案将把 ISAW 的使用范围从 PD 扩大到老年跌倒者。我们将与最大的老年男性跌倒纵向研究——男性骨质疏松性骨折研究 (MrOS) 合作，以描述 361 名社区老年男性的平衡和步态特征，并与俄勒冈州老龄化与技术中心 (ORCATECH) 合作97 名社区老年妇女。该提案不仅将证明 ISAW 快速量化多中心临床试验的平衡和步态的可行性和有用性，还将制定独特的跌倒风险报告，并为 ISAW 提供规范性参考。 对老年人的价值观。这项为期 3 年的研究将同时具有临床研究和技术开发目标，以使 ISAW 做好准备，将市场渗透率从研究扩大到临床实践，作为跌倒风险和行动障碍的客观生物标志物。 ISAW 将对有兴趣测量老年人跌倒风险的临床医生产生影响，包括初级保健医生、神经科医生、老年科医生、康复专业人员、辅助生活设施、医院和运动教练。具体目标是： 目标 I. 临床研究：通过 ISAW 测试为临床医生开发跌倒风险评估系统（里程碑 1：制定跌倒风险报告；里程碑 2：制定老年人平衡和步态完整性的参考值）。目标二。技术开发：使 ISAW 变得实用且对临床实践和临床试验有吸引力（里程碑 3. 移动性交换：为 ISAW 测试中的多站点临床数据收集准备数据存储库（里程碑 4. 移动性诊所：简化用户-临床医生的界面和报告，以及里程碑 5。FDA：建立质量体系和监管合规性，以便 ISAW 可以推向临床实践。该 II 期提案将把 APDM 的 ISAW 协议转变为 ISAW 协议。第一个技术系统为临床医生（Mobility Clinic）和临床研究人员（Mobility Lab）提供经过验证的、客观的跌倒风险评估，以及全面的平衡和步态障碍评估。