A Device to Monitor Toe Walking in Children with Cerebral Palsy

监测脑瘫儿童脚趾行走的装置

• 批准号: 7687414
• 负责人: RICHARD M GREENWALD
• 金额: $ 39.8万
• 依托单位: SIMBEX, LLC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7687414
• 关键词: Acceleration; Accounting; Activities of Daily Living; Address; Affect; Algorithms; Ankle; Behavior; Bilateral; Biomechanics; Botulinum Toxins; Cerebral Palsy; Charge; Child; Classification; Clinic; Clinical; Clinical Data; Clinical Research; Complement; Computer software; Cost Analysis; Data; Data Analyses; Data Collection; Data Set; Data Storage and Retrieval; Databases; Development; Devices; Diagnosis; Diagnostic; Disease Progression; Electronics; Environment; Evaluation; Frequencies; Gait; Gait abnormality; Goals; Gold; Head; Health Care Costs; Home environment; Hospitals; Incidence; Individual; Injection of therapeutic agent; Insurance; Intervention; Kinetics; Laboratories; Lead; Life; Longitudinal Studies; Marketing; Measurement; Measures; Memory; Methods; Modeling; Monitor; Motor; Multiple Sclerosis; Operative Surgical Procedures; Orthotic Devices; Outcome; Outcome Assessment; Outcome Measure; Parkinson Disease; Pathology; Patients; Pattern; Pattern Recognition; Phase; Pilot Projects; Population; Process; Quality of life; Ramp; Rehabilitation therapy; Research; Research Personnel; Sensitivity and Specificity; Severities; Shoes; Small Business Innovation Research Grant; Staging; System; Techniques; Technology; Tendon structure; Testing; Time; Toes; Toxin; Treatment Efficacy; United States National Institutes of Health; Validation; Video Recording; Walking; Weight; Work; adopted child; base; clinical Diagnosis; clinical practice; commercialization; community setting; comparative efficacy; cost; data acquisition; design; effective intervention; experience; foot; gait examination; improved mobility; indexing; innovation; kinematics; meetings; monitoring device; novel; orthotics; pressure; product development; prototype; research and development; research clinical testing; response; sensor; software development; success; time interval; tool

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.

描述（由申请人提供）：该SBIR项目的这个目标是量化和验证针对患有脑瘫儿童（CP）儿童的非遮盖，可穿戴的，鞋带的步态监测装置的可行性和潜力。假设，临床实验室外CP儿童以及在正常日常活动中的CP儿童的简单步态参数的持续监控和分析将提供临床上有用的结果数据，这些数据目前尚不可用，以及用于确定干预时间的关键诊断数据。临床需要进行客观的定量数据，以评估步行的严重程度及其随着时间的流逝而随着孩子的发展而进行的，并实施了干预策略，以提高他/她的流动性。此外，将这种评估扩展到家庭和社区环境至关重要，对于允许临床医生评估临床干预措施是否有效地改善诊所以外的流动性以及总体上儿童生活质量。关键创新是开发微型低功率数据采集/记录设备，在日常生活活动（ADL）活动期间，CP的儿童可以非饰演，以测量行动期间的脚踝角度和压力轨迹中心。在第一阶段，硬件/软件开发和验证将进行一项针对CP儿童的试点研究，以比较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。将采用数据聚类技术来确定单独监视数据对这些运动任务进行分类的可行性，并确定不同的门诊活动（即，水平的步行，坡道上升和下降，以及楼梯上升和下降）。在第二阶段中，硬件被合并到运动鞋的鞋底中，开发和验证了多阶段分类器，并进行了试点纵向研究以评估新型脚趾步行严重性（TWS）索引的开发。该研究和开发项目的长期目标是解决与步态异常的客观量化相关的临床问题，以及通过开发低成本，易于获得的鞋内监测工具和分析方法来纵向量化脚趾在临床环境外行走的严重程度。如果成功，则提出的技术将对受到其他病理影响的患者的步态有巨大潜力，在其他病理中，预计步态参数会随着时间的流逝而随着疾病进展而变化（例如，帕金森氏病的患者改组，逐渐丧失多发性硬化症患者脚踝控制的脚踝控制）。拟议的ActiveGait设备提供了能够连续监视脚趾在家里行走的技术。根据个人在家里和长时间步行中收集的非常大的数据，将开发量化脚趾步行临床干预措施的成功和时机的结果措施。如果在技术上和经济上可行，则鞋子中监测系统的额外前期成本将远远超过与治疗和脚趾步行的治疗和康复相关的医疗保健费用的降低。