Development of an Instrumented System to Measure Mobility in Parkinson's Disease

描述(由申请人提供)： (面向公众的30行)本申请涉及广泛的挑战领域(07)：加强临床试验和特定挑战主题，07-NS-101：开发技术以提高临床试验的效率和降低成本。该项目的长期目标是使用新技术敏感地测量、自动分析和有效管理帕金森氏病(PD)和其他神经疾病的临床试验数据。该项目将致力于开发客观的平衡和步态测量方法，因为行动不便和跌倒对帕金森病患者的生活质量至关重要。临床运动障碍专家将与当地一家初创企业合作，开发、生产和测试一种新的临床平衡和步态评估工具，即用于帕金森氏症患者的仪表化定时起跳测试(ITUG)。当患者从椅子上站起来、走路、转身和回到椅子上时，将通过在手腕、脚踝和躯干上佩戴无线传感器来测量平衡和步态。传感器的加速度和角速度将自动传输、存储、分析，并在远程中央计算机上显示为移动性评分，以及对临床试验重要的其他患者信息。具体地说，这项建议将1)创建一个商业上可用的临床试验系统，其中包括完全无线传感器技术、定制的、用户友好的计算机界面和高效的数据管理服务器；2)根据许多潜在的平衡和步态测量开发移动性评分；3)与传统的平衡临床测试相比，iTUG对抗帕金森药物引起的帕金森病患者的PD变化的敏感性进行比较。通过提供一种更敏感、更准确和更全面的方法来快速测试和分析平衡和步态，改善帕金森氏症和其他神经疾病患者行动能力的临床试验将显著更有效和高效。这将使帕金森氏症的临床试验能够以更少的受试者、更短的持续时间和更低的成本完成。目前的项目将加快帕金森氏症新疗法的开发。该项目将使用新技术开发客观仪器，并对帕金森氏症和其他神经疾病的平衡和步态进行集中监测。这些新工具将允许以更少的受试者、更短的持续时间和更低的成本完成旨在减少行动不便的临床试验。

DESCRIPTION (provided by applicant): (30 lines for public) This application addresses the broad Challenge Area (07): Enhancing Clinical Trials and specific Challenge Topic, 07-NS-101: Developing technology to increase efficiency and decrease cost of clinical trials. The long- term objective of this project is to use new technologies to sensitively measure, automatically analyze and efficiently manage clinical trial data for Parkinson's disease (PD) and other neurological disorders. This project will focus on developing objective measures of balance and gait because mobility disability and falls are so critical for quality of life in PD. Clinical movement disorders experts will team up with a local start-up business to develop, produce, and test a novel clinical balance and gait assessment tool, the instrumented Timed Up and Go Test (iTUG) for patients with Parkinson's disease. Balance and gait will be measured with wireless sensors worn on the wrists, ankles and trunk while patients stand up from a chair, walk, turn and return to sit on the chair. Accelerations and angular velocities from the sensors will be automatically transmitted, stored, analyzed, and displayed as Mobility Scores on a remote, centralized computer, along with other patient information important for clinical trials. Specifically, this proposal will 1) create a commercially-available, clinical trial system that includes completely wireless sensor technology, a custom-made, user-friendly, computer interface and efficient data management server; 2) develop a mobility score from many potential balance and gait measures and 3) compare the sensitivity of the iTUG compared to traditional clinical tests of balance to changes in PD due to antiparkinson medication. By providing a more sensitive, accurate, and comprehensive method to quickly test and analyze balance and gait, clinical trials to improve mobility in patients with Parkinson's disease and other neurological disorders will be significantly more effective and efficient. This will permit clinical trials in Parkinson's disease to be completed with fewer subjects, shorter duration, and less cost. The current project will accelerate the development of new therapies for Parkinson's disease. This project will use new technology to develop objective instruments and centralized monitoring of balance and gait for Parkinson's disease and other neurological disorders. These new tools will permit clinical trials aimed at reducing mobility disability to be completed with fewer subjects, shorter duration, and less cost.