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

描述（由申请人提供）：本SBIR一期提案的总体目标是建立rgr -步态仪器化分析系统的测量可靠性和临床可行性。步态功能障碍会严重影响一个人的日常生活能力，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，二维步态分析不能捕捉到许多关键的三维步态特征。如果在典型的临床中能够更客观地量化三维步态偏差，临床结果可能会得到改善，但目前的三维系统过于占用空间，成本高昂，技术要求也太高。Retro-Grate Reflector (RGR) 3d运动捕捉系统是一种新颖的单摄像头3d运动跟踪技术，填补了临床需求与现有3d系统之间的空白。通过使用轻质多层无源光学目标产生的云纹图案的创新，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、对多个目标的自动跟踪以及对光照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创新公司正在开发用于临床部署的rgr -步态系统。本提案的两个目的是建立试验间、会话间和测试者间的可重复性，并证明rgr -步态系统的临床可行性。一个系统将被构建并部署到将进行测试的物理治疗诊所。第一个目标是，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例骨科患者的步态偏差。这项研究的结果将导致第二阶段，这将侧重于建立临床站点和临床人群之间的测量可靠性。第二阶段还将完善技术、软件和全面商业化的技术支持。

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.