ParkinStep: Automated PD Gait and Balance Assessment for Optimizing DBS

ParkinStep：用于优化 DBS 的自动 PD 步态和平衡评估

• 批准号: 7746783
• 负责人: JOSEPH P GIUFFRIDA
• 金额: $ 24.83万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7746783
• 关键词: Adverse effects; Affect; Algorithms; Amplifiers; Attention; Bradykinesia; Clinical; Clinical Research; Clinical Trials; Complex; Computer software; Custom; Data; Deep Brain Stimulation; Development; Devices; Diagnostic; Disease; Dystonia; Electromyography; Equilibrium; Evaluation; Feedback; Figs - dietary; Fingers; Functional disorder; Gait; Gait abnormality; Growth; Hip Fractures; Home environment; Housing; Human; Huntington Disease; Intervention; Life; Lower Extremity; Measures; Memory; Minor; Modification; Monitor; Motion; Motor; Movement; Movement Disorders; Muscle Rigidity; Neurologist; Operative Surgical Procedures; Outcome; Outcome Assessment; Outpatients; Output; Parkinson Disease; Patients; Pattern; Performance; Pharmacologic Substance; Pharmacotherapy; Phase; Process; Protocols documentation; Quality of life; Radio; Reporting; Research; Research Personnel; Resolution; Risk; Severities; Symptoms; System; Technology; Testing; Time; Treatment Efficacy; Tremor; Upper Extremity; Visual; Wireless Technology; base; computerized data processing; data acquisition; data exchange; design; falls; follow-up; improved; insight; movie; novel; patient safety; programs; prototype; public health relevance; response; sensor; success; tool

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess ParkinStep", a compact, portable, wireless movement disorder monitor technology to quantify gait and balance performance in Parkinson's disease (PD). A standardized platform for repeatable, automated testing to assess gait and balance in response to deep brain stimulation (DBS) settings should optimize patient outcomes and provide a novel research tool for new DBS protocols targeted to gait and balance. There has currently been tremendous growth and active research into PD pathophysiology and treatment including pharmaceutical interventions and DBS. Efficacy is judged by alleviation of patient symptoms and improved quality of life. After initial DBS surgery, several follow-up examinations optimize stimulation parameters to minimize motor symptoms and side effects, increase battery life, and decrease required drug therapy. The current standard in symptom evaluation is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. During DBS programming sessions, a neurologist typically assesses upper extremity function using a subset of the UPDRS motor exam. While gait and balance are critical components to quality of life measures and irregular lower extremity function can be disabling, these often receive less attention than upper extremity counterparts. CleveMed has previously developed a technology platform called ParkinSense" to quantify upper extremity PD motor symptoms. Clinical trials have been conducted with PD subjects to quantitatively assess severity of tremor and bradykinesia. Outputs were highly correlated with clinicians' qualitative UPDRS scores. Additionally, the objective, quantitative ParkinSense output scores provided increased resolution on a continuous scale compared to visual observations using the discrete UPDRS. With only minor hardware upgrades required for gait and balance and excellent clinical results to date, this previously existing base enhances likelihood of project success. We hypothesize ParkinStep will successfully capture quantitative symptom variables related to gait and balance, process those variables into a algorithm whose output correlates to qualitative clinician scoring of gait and balance, and demonstrate high clinical acceptability by both patients and clinicians. This development will continue CleveMed's path to providing a standardized platform for quantitatively assessing all components of the UPDRS motor section. PUBLIC HEALTH RELEVANCE: Parkinson's disease is primarily characterized by the "classic" motor symptoms of tremor, bradykinesia, and rigidity; however, other lower extremity symptoms such as balance and gait disturbances, especially in advanced patients, can be very debilitating, leading to decreased mobility and independence, decreased quality of life and an increased falling/hip fracture risk. Clinicians lack quantitative tools to optimize deep brain stimulation programming for alleviating Parkinson's motor symptoms. ParkinStep" will be a repeatable, automated tool that can quantify lower extremity motor function and assist stimulation programming during outpatient follow up to optimize patient outcomes.

描述（由申请人提供）：目的是设计，建造和临床评估Parkinstep”，这是一种紧凑，便携式，无线运动障碍监控技术，以量化帕金森氏病（PD）的步态和平衡性能。一个标准化的平台，用于重复，自动测试，以评估对脑刺激的响应（DBS）设置的响应（DBS），并为患者提供了新的小说工具，并为新的研究提供了新的小说工具，并为新的小说工具提供了启发。目前已经对PD病理生理学进行了巨大的研究，包括药物干预措施和DBS，通过减轻患者的症状和最初的DBS手术质量来判断。 （UPDRS），一个定性排名系统。在DBS编程课程中，神经科医生通常使用UPDRS运动检查的子集评估上肢功能。尽管步态和平衡是生活质量措施和不规则下肢功能的关键组成部分，但这些功能通常比上肢的关注较少。 Clevemed先前已经开发了一个名为Parkinsense的技术平台“用于量化上肢PD运动症状。临床试验是通过PD受试者进行的，以定量评估震颤和Bradykinesia的严重程度。输出与临床医生的定性上升分数高度相关。此外，使用目标parkinsense Inticles的确定性量表量相比，临床医生的定性上升量相比。迄今为止，只有步态和平衡和出色的临床结果所需的次要硬件，我们假设项目成功的可能性会成功捕获与步态和平衡相关的定量症状变量Clevemed提供了标准化平台，用于定量评估UPDRS电机部分的所有组件。公共卫生相关性：帕金森氏病的主要特征是震颤，胸肌和僵化的“经典”运动症状；但是，其他下肢症状，例如平衡和步态障碍，尤其是在高级患者中，可能会非常衰弱，导致流动性和独立性下降，生活质量降低以及降低/髋部骨折风险增加。临床医生缺乏定量工具来优化深脑刺激程序，以减轻帕金森氏症的运动症状。 ParkInstep”将是一种可重复的自动化工具，可以量化下肢运动功能，并在门诊后续行动期间有助于刺激程序以优化患者的预后。