Home biofeedback (VibroGait) for people with impaired somatosensation

项目摘要 躯体感觉受损或神经系统对躯体感觉的使用受损是最常见的 老年人平衡和行走障碍的原因。人体平衡和步态控制系统依赖于 在行走过程中脚与支撑表面接触的体感信息上。躯体感觉丧失 常见于糖尿病、正常衰老、中风，以及神经系统疾病中的中枢处理受损， 帕金森氏病、多发性硬化症和共济失调。躯体感觉受损会增加 福尔斯是残疾和死亡的主要原因。在没有成功的治疗方法来恢复内在的 感觉反馈，我们专注于使用外在（增强）感觉反馈，以提供补充感觉 以增强病人受损的感觉系统反馈是一种增强反馈， 实时提示，以改善运动控制，并帮助关闭破碎的感觉-运动控制回路。 这一快速通道SBIR将使APDM能够为VibroGait的商业发布做好准备， 在日常生活中使用的振动触觉反馈系统。具体来说，我们将开发一种智能服装， 其具有惯性感测单元和微控制器以与容纳在智能传感器中的触觉器无线通信， 将振动触觉刺激传递到有足够躯体感觉所需身体部分， 感知振动信号这种独立的系统将是一个可拆卸的病人，以及易于使用和转动 在不需要的时候。VibroGait还可以插入APDM先进的移动实验室，该实验室使用先进的 并验证了步态算法和云数据库，使临床研究人员能够监测移动障碍 和遵守VibroGait的使用。该项目有两个主要目标。我们的技术开发目标是 准备VibroGait用于临床实践和FDA 510（k）临床市场许可。我们的临床研究目标是 证明VibroGait在改善家庭活动质量方面的临床实用性和有效性。

Project Summary Impaired somatosensation or impaired use of somatosensation by the nervous system is one of the most common causes of balance and walking disability in older individuals. The human balance and gait control systems rely on somatosensory information from foot contact with the support surface during walking. Somatosensory loss is common with diabetes, normal aging, stroke, and with impaired central processing in neurological disorders such as Parkinson's disease (PD), multiple sclerosis, and ataxia. Impaired somatosensation results in increased risk of falls and is a major contributor to disability and death. In the absence of successful treatments to restore intrinsic sensory feedback, we focus on using extrinsic (augmented) sensory feedback to provide complementary sensory cueing to augment the patient's impaired sensory system. Feedback is a type of augmented feedback that provides real-time cueing to improve motor control and help close the broken sensory-motor control loop. This Fast-Track SBIR will allow APDM to prepare VibroGait for a commercial launch as the first wireless, gait vibrotactile feedback system to be used during daily life. Specifically, we will develop a smart garment instrumented with an inertial sensing unit and a microcontroller to wirelessly communicate with a tactor housed in a smart silicone band to deliver vibrotactile stimulus to a desired body segment where there is adequate somatosensation to perceive the vibratory cues. This standalone system will be a↵ordable to patients as well as easy to use and to turn o↵ when not needed. VibroGait can also be plugged into APDM's advanced Mobility Lab, which uses sophisticated and validated gait algorithms and a cloud database, to enable clinical researchers to monitor mobility impairments and compliance of use of VibroGait. This project has two main aims. Our technology development aim is to prepare VibroGait for clinical practice and FDA 510(k) clearance to clinical market. Our clinical research aim is to demonstrate the clinical utility and e↵ectiveness of VibroGait in improving quality of mobility at home.