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、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正常日常活动期间连续监测和分析CP儿童的简单步态参数将提供目前不可用的临床有用结局数据和确定干预时机的关键诊断数据。临床上需要客观的定量数据来评估脚趾行走的严重程度及其随时间的进展，因为儿童的发展和干预策略的实施，以改善他/她的流动性。此外，将这种评估扩展到家庭和社区环境是至关重要的，以便临床医生能够评估临床干预措施是否有效地改善了诊所外的流动性和儿童的整体生活质量。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，该设备可以在日常生活活动（ADL）期间由CP儿童非侵入性地佩戴，以测量踝关节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CP儿童进行试点研究，以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。将采用数据聚类技术来确定仅根据鞋内监测数据对这些运动任务进行分类的可行性，并识别不同的走动活动（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，硬件被纳入到唯一的运动鞋，一个多阶段的分类器的开发和验证，并进行试点纵向研究，以评估发展的一种新的脚趾行走严重程度（TWS）指数。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，从而解决与步态异常的客观量化和临床干预的成功相关的临床问题。如果成功，所提出的技术具有监测受其他病变影响的患者的步态的巨大潜力，其中步态参数预计随着疾病进展而随时间变化（例如帕金森病患者的拖曳，多发性硬化症患者的踝关节控制的进行性丧失）。所提出的ActiveGait设备提供了使能技术，以连续监测脚趾步行在家里。量化脚趾行走临床干预的成功和时机的结果指标将基于从个人在家和长时间行走中收集的大量数据来开发。如果在技术和经济上可行，鞋中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保健成本的减少。

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.