A Device to Monitor Toe Walking in Children with Cerebral Palsy

描述(由申请人提供)：该SBIR项目的目标是量化和验证用于脑瘫(CP)儿童的非侵入性、可穿戴的鞋内步态监测设备的可行性和潜力。假设在临床实验室外和在正常日常活动中持续监测和分析CP儿童的简单步态参数将提供目前无法获得的临床有用的结果数据，以及确定干预时机的关键诊断数据。临床上需要客观、定量的数据来评估脚趾行走的严重程度及其随时间的发展，并实施干预策略以改善儿童的活动能力。此外，将这种评估扩展到家庭和社区环境是至关重要的，以使临床医生能够评估临床干预措施在改善儿童在诊所外的活动能力和总体生活质量方面是否有效。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，该设备可供患有脑瘫的儿童在日常生活活动(ADL)中非显眼地佩戴，以测量行走时的脚踝角度和压力轨迹中心。在第一阶段，在硬件/软件开发和验证之后，将对患有脑瘫的儿童进行试点研究，将测量的鞋内步态参数与黄金标准的实验室运动学和运动学数据进行比较。将采用数据分类技术，以确定仅从鞋内监测数据对这些运动任务进行分类的可行性，并识别不同的步行活动(即水平行走、坡道上升和下降以及楼梯上升和下降)。在第二阶段，将硬件集成到运动鞋的鞋底，开发并验证了多级分类器，并进行了试点纵向研究，以评估一种新的脚趾行走严重程度(TWS)指数的开发。这一研究和开发项目的长期目标是通过开发低成本、现成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，解决与客观量化步态异常和临床干预成功相关的临床问题。如果成功，这项拟议的技术将为监测受其他疾病影响的患者的步态带来巨大潜力，在这些疾病中，步态参数预计会随着疾病的进展而随着时间的推移而变化(例如，帕金森氏病患者的步态改变，多发性硬化症患者的脚踝逐渐失去控制)。提出的ActiveGait设备提供了在家中连续监控脚趾行走的技术。将根据从个人在家和长时间步行中收集的极大数据，制定量化脚趾行走临床干预措施的成功和时机的结果衡量标准。如果技术上和经济上可行，鞋内监测系统的额外前期成本将远远超过与脚趾行走治疗和康复相关的医疗费用的减少。

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.