A Device to Monitor Toe Walking in Children with Cerebral Palsy

描述（由申请人提供）：这个SBIR项目的目标是量化和验证一种用于脑瘫（CP）儿童的非突发性、可穿戴、鞋内步态监测设备的可行性和潜力。假设在临床实验室之外和日常活动期间对CP患儿简单的步态参数进行持续监测和分析，将提供目前无法获得的临床有用的结果数据和确定干预时机的关键诊断数据。临床需要客观、定量的数据来评估儿童脚趾行走的严重程度及其随时间发展的进展，并实施干预策略以改善他/她的活动能力。此外，将这种评估扩展到家庭和社区环境是至关重要的，以便临床医生评估临床干预是否有效地改善了儿童在诊所外的活动能力和整体生活质量。关键的创新是开发了一种微型极低功耗数据采集/记录设备，可以让患有CP的儿童在日常生活活动（ADL）中不显眼地佩戴，以测量行走时的脚踝角度和压力轨迹中心。在第一阶段，硬件/软件开发和验证之后，将对患有CP的儿童进行试点研究，将测量的鞋内步态参数与金标准实验室运动学和动力学数据进行比较。数据聚类技术将用于确定仅从鞋内监测数据分类这些运动任务的可行性，并识别不同的走动活动（即水平行走，坡道上行和下行，楼梯上行和下行）。在第二阶段，将硬件整合到运动鞋的鞋底，开发并验证了多阶段分类器，并进行了纵向试验研究，以评估新型脚趾行走严重程度（TWS）指数的发展。该研究和开发项目的长期目标是通过开发低成本，易于获得的鞋内监测工具和分析方法来纵向量化临床环境外脚趾行走的严重程度，解决与步态异常客观量化和临床干预成功相关的临床问题。如果成功，该技术将具有监测受其他疾病影响的患者的步态的巨大潜力，这些疾病的步态参数预计会随着时间的推移而变化，作为疾病进展的函数（例如帕金森病患者的步履蹒跚，多发性硬化症患者的脚踝逐渐失去控制）。所提出的active步态设备提供了使能技术，可以在家中持续监测脚趾行走情况。将根据从个人在家和长时间行走中收集的大量数据，制定量化脚趾行走临床干预成功和时机的结果测量方法。如果在技术上和经济上可行，鞋内监测系统的额外前期成本将被减少的与脚趾行走治疗和康复相关的卫生保健费用所远远抵消。

DESCRIPTION (provided by applicant): This goal of this SBIR project is to quantify and validate the feasibility and potential for a non- obtrusive, wearable, in-shoe gait-monitoring device for children with Cerebral Palsy (CP). It is hypothesized that continuous monitoring and analysis of simple gait parameters in children with CP outside the clinical laboratory and during normal daily activities will provide clinically useful outcomes data that are not currently available and critical diagnostic data for determining intervention timing. There is a clinical need for objective, quantitative data to assess the severity of toe walking and its progression over time as the child develops and intervention strategies are implemented to improve his/her mobility. Also, extending such assessment to the home and community settings is critical in order to allow clinicians to evaluate whether clinical interventions are effective in improving mobility outside of the clinic and overall the quality of life of the child. The key innovation is the development of a miniature extremely low-power data acquisition/recording device, which can be worn non-obtrusively by children with CP during activities of daily living (ADL's) to measure ankle angle and center of pressure trajectories during ambulation. In Phase I, hardware/software development and validation will be followed by a pilot study of children with CP to compare measured in-shoe gait parameters against gold- standard laboratory kinematic and kinetic data. Data clustering techniques will be employed to determine the feasibility of classifying these motor tasks from the in-shoe monitoring data alone, and to identify different ambulatory activities (i.e. level walking, ramp ascending and descending, and stair ascending and descending). In Phase II, the hardware is incorporated into the sole of a sneaker, a multi-stage classifier is developed and validated, and a pilot longitudinal study is performed to evaluate the development of a novel Toe Walking Severity (TWS) index. The long-term goal of this research and development project is to address clinical problems associated with objective quantification of gait abnormalities and the success of clinical interventions by developing low cost, readily available in-shoe monitoring tools and analysis methods to quantify longitudinally the severity of toe walking outside the clinic environment. If successful, the proposed technology carries significant potential for monitoring gait in patients affected by other pathologies in which gait parameters are expected to change over time as a function of the progression of the disease (e.g. shuffling in patients with Parkinson's disease, progressive loss of ankle control in patients with multiple sclerosis). The proposed ActiveGait device provides the enabling technology to continuously monitor toe walking at home. Outcome measures quantifying the success and timing of clinical interventions for toe walking will be developed based on extremely large data gathered from the individual's walking at home and over long periods of time. If technically and economically feasible, the additional up-front cost of the monitoring system in the shoe will be far outweighed by reduced health care costs associated with treatment and rehabilitation for toe walking.