Home biofeedback (VibroGait) for people with impaired somatosensation

针对体感受损人士的家庭生物反馈 (VibroGait)

• 批准号: 10011639
• 负责人: Mahmoud El-Gohary
• 金额: $ 24.91万
• 依托单位: APDM, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2020-10-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10011639
• 关键词: Algorithms; Ankle; Area; Ataxia; Auditory; Biofeedback; Cessation of life; Characteristics; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Cues; Custom; Databases; Deterioration; Diabetes Mellitus; Equilibrium; Esthesia; Feedback; Gait; Goals; Health; Health Sciences; Home environment; Human; Impairment; Incidence; Individual; Intervention; Laboratories; Laboratory Study; Life; Limb structure; Measures; Monitor; Multiple Sclerosis; Nervous system structure; Oregon; Parkinson Disease; Patients; Pattern; Persons; Phase; Population; Preparation; Process; Randomized; Research; Research Personnel; Risk; Safety; Self-Help Devices; Sensory; Signal Transduction; Silicones; Small Business Innovation Research Grant; Stimulus; Stroke; Surface; System; Tactile; Task Performances; Techniques; Technology; Time; Training; Universities; Visual; Walking; Wireless Technology; base; clinical practice; cost; design; disability; fall injury; fall risk; falls; foot; gait rehabilitation; improved; improved mobility; instrument; motor control; nervous system disorder; normal aging; novel; portability; prototype; sensor; sensory feedback; sensory integration; sensory system; somatosensory; technology development; verification and validation; vibration; vibrotactile stimulation

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.

项目概要 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疾病之一 老年人平衡和行走障碍的原因依赖于人体平衡和步态控制系统。 步行过程中足部与支撑面接触的体感信息是体感损失。 常见于糖尿病、正常衰老、中风以及神经系统疾病中枢处理受损的情况，例如 帕金森病 (PD)、多发性硬化症和共济失调会导致患上这种疾病的风险增加。 在没有成功的治疗来恢复内在的情况下，跌倒是导致残疾和死亡的主要原因。 感觉反馈，我们专注于使用外在（增强）感觉反馈来提供补充感觉 提示以增强患者受损的感觉系统。反馈是一种提供增强反馈的类型。 实时提示可改善运动控制并帮助闭合破碎的感觉运动控制回路。 此 Fast-Track SBIR 将使 APDM 能够为 VibroGait 的商业发布做准备，作为第一个无线步态 具体来说，我们将开发一种智能服装仪表化的振动触觉反馈系统。 带有惯性传感单元和微控制器，可与智能控制器中的接触器进行无线通信 硅胶带可将振动触觉刺激传递到所需的身体部位，在该部位有足够的躯体感觉 该独立系统对于患者来说是可以接受的，并且易于使用和转动。 o↵ 不需要时，VibroGait 也可以插入 APDM 的高级移动实验室，该实验室使用复杂的技术。 以及经过验证的步态算法和云数据库，使临床研究人员能够监测行动障碍 VibroGait 的使用合规性 我们的技术开发目标有两个。 准备 VibroGait 进行临床实践并获得 FDA 510(k) 临床市场许可。 展示 VibroGait 在提高家庭活动质量方面的临床实用性和有效性。