An innovative tool for assessment of gait dysfunction in the clinical setting

描述（由申请人提供）：SBIR第I阶段提案的总体目标是确定RGR-GAIT仪器化步态分析系统的测量可靠性和临床可行性。步态功能障碍可以显着影响一个人的日常生活活动的能力，步态评估是物理治疗实践的关键组成部分。目前，绝大多数物理治疗诊所无法使用仪器步态分析。正因为如此，大多数临床医生依赖于观察步态分析，这已被证明具有不足的可靠性和有效性。此外，二维步态分析没有捕获许多关键的三维（3-D）步态特征。如果三维步态偏差可以在典型的诊所中更客观地量化，则可以改善临床结果，但是当前的3-D系统太占用空间、成本高并且技术要求高。Retro-Grate Reflector（RGR）三维运动捕捉系统是一种新型的单摄像头三维运动跟踪技术，填补了临床需求和当前可用的三维系统之间的差距。通过创新使用由轻型多层无源光学目标产生的莫尔图案，RGR技术能够用单个相机确定3D信息。RGR系统的单摄像头操作、多目标自动跟踪和对照明条件的鲁棒性使其技术要求较低，并克服了仪器步态分析广泛临床应用的障碍。Metria Innovation正在开发用于临床部署的RGR-GAIT系统。本提案的两个目的是建立试验间、会话间和测试者间的重复性，并证明RGR-GAIT系统的临床可行性。将构建一个系统并部署到将进行测试的物理治疗诊所。对于第一个目标，两名治疗师将在两天内收集10名健康受试者的3D步态数据。此外，10名骨科患者将在一天内由两名治疗师进行评估。这些可靠性数据将为目标2提供信息，目标2将客观量化10名骨科患者的步态偏差。本研究的结果将进入II期，重点是建立临床研究中心之间和临床人群内的测量可靠性。第二阶段还将完善技术、软件和技术支持，以实现全面商业化。 公共卫生相关性：步行评估是各种骨科、神经和心肺疾病康复的关键组成部分。在临床环境中改善对行走和其他运动的评估可以通过改善治疗计划来显著改善患者结局并降低成本。该项目的结果将是一个创新的步态分析系统，以满足这一需求。

DESCRIPTION (provided by applicant): The overall goal of this SBIR Phase I proposal is to establish the measurement reliability and the clinical feasibility of the RGR-GAIT instrumented gait analysis system. Gait dysfunction can dramatically affect a person's ability to perform activities of daily living, and assessment of gait is a critical component of physical therapy practice. Currently, instrumented gait analysis is inaccessible to the vast majority of physical therapy clinics. Because of this, most clinicians depend on observational gait analysis, which has been shown to have inadequate reliability and validity. Further, two-dimensional gait analysis does not capture many critical three- dimensional (3-D) gait features. Clinical outcomes could be improved if three-dimensional gait deviations could be more objectively quantified in a typical clinic, but current 3-D systems are too space intensive, costly, and technically demanding. The Retro-Grate Reflector (RGR) 3-D motion capture system is a novel single-camera 3-D motion tracking technology that fills the gap between clinical need and currently available 3-D systems. Through innovation in the use of moire patterns generated by a lightweight, multi-layer passive optical target, the RGR technology is able to determine 3-D information with a single camera. The RGR system's single camera operation, automatic tracking of multiple targets and robustness to lighting conditions make it less technically demanding and overcomes the barriers for broad clinical use of instrumented gait analysis. Metria Innovation is developing the RGR-GAIT system for clinical deployment. The two aims of this proposal are to establish the inter-trial, inter-session, and inter-tester repeatability and to demonstrate the clinical feasibility of the RGR-GAIT system. A system will be constructed and deployed to a physical therapy clinic where the testing will take place. For the first aim, two therapists will collect 3-D gait data on ten healthy subjects across two days. In addition, ten orthopedic patients will be assessed by two therapists on a single day. These reliability data will inform aim 2, which will objectively quantify gait deviations in the ten orthopedic patients. The results of this study will lead to Phase II, which will focus on establishing measurement reliability between clinical sites and within clinical populations. Phase II will also refine the technology, software, and technical support for full commercialization. PUBLIC HEALTH RELEVANCE: Assessment of walking is a critical component of rehabilitation for a variety of orthopedic, neurological, and cardiopulmonary conditions. Improved assessment of walking and other movement in the clinical setting can dramatically improve patient outcomes and reduce costs by improving treatment planning. The result of this project will be an innovative gait analysis system to meet this need.