Name: home-based monitor for gait and activity analysis
Uploaded: 2019-08-08T13:30:00
Description: Watch this Scientific Journal Video about Home-Based Monitor for Gait and Activity Analysis at JoVE.com

作者感谢安妮-盖尔·勒莫因、阿梅利·莫洛和埃里克·多尔沃为开发这种可穿戴磁惯性传感器和杰基·怀亚特所做的评论。

对设备的任何使用必须按照参考协议制定的规则进行,该规则经道德委员会和国家监管机构的验证。设备的使用及其所连接的各种元件必须在患者手册中描述的预期用途内完成。
注:要有资格使用 WMIS,患者必须超过 5 岁,能够理解和遵守使用规则,提供知情同意,成为社会保障计划的附属或受益人,并能够遵守所有协议要求。没有特定的排除条件。
1. 为参与...

<ol>
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在过去十年中,已经开发了许多不同的系统,例如活动监测仪(材料表[IV]),它使用加速传感器来监测日常生活的活动,以量化能源支出13。Tanaka等人14日使用三轴加速度计(材料表[V])监测学龄前儿童的活动。Lau等人15通过双加速度计(材料表[VI])和陀螺仪(材料表[VII])的组合表明,步态时空特性可以通过惯...

一些潜在的疗法正在开发,用于治疗遗传性神经肌肉疾病。这些疾病包括杜琴肌肉营养不良(DMD)和脊髓肌肉萎缩(SMA)类型3。患有这些疾病的受试者最初存在近下肢无力,导致在行进困难。转化研究的最后一步是在临床试验中演示潜在治疗或方法的疗效。需要采取具体、可量化、客观和可靠的措施。这些措施的重要性最近被强调为第一阶段Ataluren试验1和三期生物马林试验2的失败。这些失败的可能原因之一是这些试验的主要结果度量的可变性和非线性演变,6分钟步行试验3(6MWT)。提高可靠性和对结果措施变化的敏感性,以及了解导致结果变化的因素,可有助于减少与主要结果措施有关的试验失败次数。
当前结果的局限性之一是评估的主观性。为了进一步提高评估的客观性,Heberer等人4表明,通过标记集和使用步态分析软件,与天真的组相比,使用类固醇治疗的患者的步长显著增加。髋关节动力学是DMD患者近端虚弱的早期标志物,对类固醇干预的变化有反应,这是这些患者唯一可用的治疗方法。然而,盖特实验室只能在大型诊所使用。此外,实验室评估是点评估,由于疲劳、动机和间流疾病等因素,患者的病情可能每天都在变化很大。
使用持续和基于家的测量应实现更客观和更具全球代表性的评估。在其他神经学领域,例如帕金森5或多发性硬化症6,一些研究已经评估了不同传感器(包括带或不带加速度计)的可行性、可靠性和与其他测量的一致性陀螺仪或磁力计,但这些设备目前都不是在临床试验期间评估患者的黄金标准。在神经肌肉疾病领域,目前尚无经过验证的患者持续家庭监测方法。近年来,通过临床医生和工程师的密切合作,巴黎泌理学研究所已经开发出多种用于上肢评估的装置,以精确评估上肢的强度和功能7,8,9.与一家专门从事导航系统的公司合作开发了可穿戴磁惯性传感器(WMIS;即ActiMyo)。最初,一种用于患有DMD和SMA10、11等神经肌肉疾病的非肌肉病患者的监测设备,现在使用同一设备来监测两种不同配置的肌瘤患者:两种疾病的传感器脚踝或手腕上的一个传感器,另一个在脚踝。非运动人群的配置由轮椅上的传感器和手腕上的传感器组成。
此 WMIS 能够精确捕获和量化放置它的肢体的所有运动。测量原理基于使用微机电系统(MEMS)惯性传感器和磁力计,通过磁惯性方程运行。专用算法允许在非受控环境中对患者的运动进行精确限定和量化。
该方法的总体目标是对患者在预定义时间内产生的任何运动进行识别和量化,并将这些措施纳入代表患者的特定于疾病的结果措施中。一段时间内的状况。
为了有效评估家中有运动障碍的移动障碍患者和非运动障碍患者,设备必须由训练有素的评估人员提供给患者,该评估人员负责确保说明已被理解。设备随设备一起提供调查员和患者手册。此 WMIS 目前用作神经肌肉和神经疾病临床试验(NCT033351270、NCT02780492、NCT01385917、NCT03039686、NCT03368742、NCT2500381)的探索性结果措施。已开发出适应病理学和/或临床试验设计的具体程序。

<table>
	<tbody>
		<tr>
			<td>ActiMyo Sensors</td>
			<td>Sysnav</td>
			<td>SF-000080</td>
			<td>Wearable magneto-inertal sensors attached to the patient for movment recording</td>
		</tr>
		<tr>
			<td>Helen Hayes marker set</td>
			<td>Vicon</td>
			<td>NA</td>
			<td>Whole body jumpsuit with predefined Vicon&#39;s spots</td>
		</tr>
		<tr>
			<td>OrthoTrak (Motion Analysis, Santa Rosa, CA, USA)</td>
			<td>Motion Lab Systems</td>
			<td></td>
			<td>Gait analysis software</td>
		</tr>
		<tr>
			<td>ActiGraph</td>
			<td>ActiGraph Corp</td>
			<td>GTM1</td>
			<td>Activity monitor, used by researchers to capture and record continuous, high resolution physical activity and sleep/wake information</td>
		</tr>
		<tr>
			<td>ActivTracer GMS LTD</td>
			<td>GMS Co. Ltd Japan</td>
			<td>AC-301A</td>
			<td>Triaxial accelerometer</td>
		</tr>
		<tr>
			<td>ADXL202E dual-accelerometer</td>
			<td>Analog Devices</td>
			<td>ADXL212AEZ</td>
			<td>High precision, low power, complete dual axis accelerometer with signal conditioned, duty cycle modulated outputs, all on a single monolithic IC.</td>
		</tr>
		<tr>
			<td>ENC-03J gyroscope</td>
			<td>Murata Electronics</td>
			<td>ENC-03J</td>
			<td>Vibration Sensors</td>
		</tr>
		<tr>
			<td>DynaPort MiniMod</td>
			<td>MCROBERTS</td>
			<td></td>
			<td>Small and light case containing a tri-axial accelerometer, a rechargeable battery, an USB connection, and raw data storage on a MicroSD card</td>
		</tr>
		<tr>
			<td>MM-2860 Sunhayato</td>
			<td>Sunhayato</td>
			<td>MM-2860</td>
			<td>3-axis accelerometer</td>
		</tr>
		<tr>
			<td>MicroStone MA3-10Ac</td>
			<td>MA3-04AC</td>
			<td>Microstone Co.</td>
			<td>Acceleration sensors</td>
		</tr>
		<tr>
			<td>RT3 Activity monitor</td>
			<td>Abledata</td>
			<td>NA</td>
			<td>Triaxial accelerometer</td>
		</tr>
		<tr>
			<td>Aparito</td>
			<td>aparito</td>
			<td>NA</td>
			<td>Wearables and disease specific mobile apps to deliver patient monitoring outside of the hospital; Elin Davies, Aparito: https://www.aparito.com/</td>
		</tr>
		<tr>
			<td>Docking station</td>
			<td>Sysnav</td>
			<td>SF-000118</td>
			<td></td>
		</tr>
		<tr>
			<td>Sensor</td>
			<td>Sysnav</td>
			<td>SF-000080</td>
			<td></td>
		</tr>
		<tr>
			<td>Bracelet 
			(black/grey L) 
			(black/grey S) (black/yellow L) (black/yellow S)</td>
			<td>Sysnav</td>
			<td>ZZ-000093 ZZ-000094 ZZ-000247 ZZ-000248</td>
			<td></td>
		</tr>
		<tr>
			<td>Patient manual</td>
			<td>Sysnav</td>
			<td>FD-000086</td>
			<td></td>
		</tr>
		<tr>
			<td>Ethernet cable (2 m max.)</td>
			<td>Sysnav</td>
			<td>IC-000458</td>
			<td></td>
		</tr>
		<tr>
			<td>Power cable 
			(EU) 
			(UK) 
			(US)</td>
			<td>Sysnav</td>
			<td>ZE-000440 ZE-000441 ZE-000442</td>
			<td></td>
		</tr>
		<tr>
			<td>Power supply unit</td>
			<td>Sysnav</td>
			<td>ZE-000443</td>
			<td></td>
		</tr>
		<tr>
			<td>Ankle strap</td>
			<td>Sysnav</td>
			<td>ZZ-000462</td>
			<td></td>
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			<td>Small bag</td>
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home-based monitor for gait and activity analysis

神经肌肉紊乱临床试验的当前结果包括运动功能量表、时位测试和由训练有素的临床评估人员执行的强度测量。这些措施稍微主观一些,在诊所或医院就诊时执行,因此构成点评估。点评估可以受日常患者状况或疲劳、动机和间流疾病等因素的影响。为了对步态和活动进行家庭监测,开发了可穿戴磁惯性传感器(WMIS)。此设备是一个运动监视器,由两个非常轻的手表传感器和一个坞站组成。每个传感器包含一个三轴加速度计、陀螺仪、磁力计和一个气压计,分别记录线性加速度、角速度、所有方向运动的磁场和大气高度。传感器可以戴在手腕、脚踝或轮椅上,用于记录受试者在白天的动作。扩展坞可在夜间上传和重新充电传感器电池。使用专有算法来计算代表所执行运动的类型和强度的参数,以分析数据。此 WMIS 可以记录一组数字生物标志物,包括累积变量(如所行走的仪表总数)和描述性步态变量,例如表示患者在预定义的时间段。

此处提供的数据是在伦理委员会和法国监管局批准的临床试验期间获得的。所有患者代表都签署了知情同意书。
该WMIS在2012年首次用于临床研究环境,用于对非肿瘤DMD患者上肢运动的对照和基于家庭的监测(NCT01611597),这证明了设备使用10的自主性和可行性。变量,如角速度的规范,加速度的垂直分量与整体加速度?...

Watch this Scientific Journal Video about Home-Based Monitor for Gait and Activity Analysis at JoVE.com

Home-Based Monitor for Gait and Activity Analysis

这种创新设备使用磁惯性传感器,允许在不受控制的环境中进行步态和活动分析。目前,作为欧洲医学机构的成果措施,资格认证过程之一将作为神经肌肉疾病临床试验的临床终点。

基于家庭的盖特和活动分析监视器

Current outcomes in neuromuscular disorder clinical trials include motor function scales, timed tests, and strength measures performed by trained clinical ...

我们的创新设备使用磁力惯性传感器精确捕获运动和专用算法，以精确识别和量化特定主体在非受控环境中的电机活动。使用连续的家用活动测量设备，能够对阿米特和非阿米特人受试者进行客观且更具全球代表性的评估。该装置最初是为了精确测量神经肌肉患者的活动而开发的。但是，它可用于各种病理的患者遭受运动，门，和活动中断。目前，该装置正被用作神经肌肉和神经系统疾病临床试验的探索性结果措施。可视化演示可根据所需的配置准确解释设备设置的主要步骤，包括放置感和方向感。要为学员访问临床中心做准备，请先检查行李箱内的物品。手提箱应包含坞站，以在夜间插入传感器，用于数据上传到 USB 密钥和电池充电;电源线分为两部分，将坞站连接到电源;以太网电缆允许与路由器接口;两个传感器允许日常活动记录;一个参与者手册，一个任务提醒，根据参与者选择的配置和流动状态连接传感器的频段;第二个参与者手册和调查员手册，一个螺丝刀，以便更换USB密钥;和空白的USB密钥。然后打印并准备分配表，以记录设备分配给参与者的任务，以便与主体进行数据调节 ID.To 将可穿戴磁惯性传感器定位在活动参与者上，使用提供的手镯将一个传感器固定在主要手的手腕上，以便波浪指向手指。将第二个传感器放在脚踝上，与手腕传感器位于同一侧，在外部马勒卢鲁上方，波浪指向前进方向。对于脚踝-脚踝配置，在每个传感器上，按照波浪的曲线放置一个鞋贴纸，并在外部马勒卢斯上方的每个脚踝上放置适当的传感器。如果贴纸是直立的，并且指向前进方向，传感器将适当放置。要将可穿戴磁力惯性传感器定位在非活动参与者上，请使用提供的手镯将一个传感器放在参与者主要手的手腕上，以便波浪指向手指。将第二个传感器放在提供的行李中，然后将袋子连接到轮椅上的安全的地方。传感器应紧贴，但手腕和/或脚踝不应太多，以防止它们旋转。此外，参与者不应切换传感器的位置。在向学员解释传感器位置后，解释传感器使用的日常工作。第一天晚上，如果互联网连接可用，参与者应将坞站插入电源，并连接到路由器。每天晚上，学员应将传感器插入坞站。两个发光二极管或坞站上的 LED 应变为橙色，以指示传感器电池正在充电，并且数据正在从传感器下载到 USB 驱动器。每天早晨，学员应验证 LED 指示灯是否为绿色，表示传感器电池已充满电，并且数据已从传感器内存中清除。然后，学员应从坞站卸下传感器，并放在评估器演示的配置中的传感器上。参与者应全天保持传感器打开，然后将传感器放回坞站。在涉及水、特殊医疗检查或任何其他可能有害的活动期间，传感器应拆下并保存在安全、稳固的表面上。在录制期结束时，参与者应将所有物品整齐地放回手提箱，并将设备带回临床中心。然后，学员应填写专用作业表。如果坞站无法连接到互联网，请使用螺丝刀从坞站卸下 USB 驱动器，并在录制期结束时将驱动器更换为空白 USB 驱动器。然后将 USB 驱动器发送给支持团队进行分析。在研究过程中选定的时间点，让分析人员从云存储中提取数据，使用专用算法分析数据，根据临床研究调整分析周期和监测报告。可穿戴磁力惯性传感器允许变量，如角速度的规范、加速度的垂直分量与整体加速度的比率、高程速率以及计算能力，这些变量用于在受控环境中参与者上肢活动的临床特征。该设备还允许在很长一段时间内识别和测量参与者的每一步幅，从而能够分析所有捕获的步幅的分布，以及计算步幅和长度的百分。这种可穿戴磁力惯性传感器可测量的几个参数对变化的敏感度低于第 95 个百分步速，但与生活质量密切相关，例如每小时行走的距离和每小时的跌落数。使用光动力学系统测试受控制参与者的闸道轨迹精度，证实了光动力学系统测量的轨迹与磁惯性传感器之间的良好一致。请记住，根据手动和临床试验要求使用设备，并确保每个参与者都符合使用设备的资格标准。我们的设备的其他应用包括多发性硬化症或帕金森病患者的进化。在这些条件下，已连接的设备已经过测试，但我们仍然缺少经过验证、敏感和可靠的结果措施，这些措施可能由监管机构进行认证。

Research

JoVE Journal

Bioengineering

Polymer Microarrays for High Throughput Discovery of Biomaterials

聚合物芯片高通量发现的生物材料

The discovery of novel biomaterials that are optimized for a specific biological application is readily achieved using polymer microarrays, which allows a ...

科研

生物工程

Self-reporting Scaffolds for 3-Dimensional Cell Culture

自我报告的支架3维细胞培养

Culturing cells in 3D on appropriate scaffolds is thought to better mimic the in vivo microenvironment and increase cell-cell interactions. The resulting ...

Hybrid &#181;CT-FMT imaging and image analysis

Hybrid Ãƒâ€šÃ‚ÂµCT-FMT imaging and image analysis

混合μCT-FMT成像和图像分析

Fluorescence-mediated tomography (FMT) enables longitudinal and quantitative determination of the fluorescence distribution in vivo and can be used to ...

Sensitive Detection of Proteopathic Seeding Activity with FRET Flow Cytometry

与FRET流式细胞仪灵敏地检测Proteopathic播种活动

Increasing evidence supports transcellular propagation of toxic protein aggregates, or proteopathic seeds, as a mechanism for the initiation and ...

Optical Control of Living Cells Electrical Activity by Conjugated Polymers

由共轭聚合物活细胞电活动的光控制

Hybrid interfaces between organic semiconductors and living tissues represent a new tool for in-vitro and in-vivo applications. In particular, conjugated ...

2D and 3D Matrices to Study Linear Invadosome Formation and Activity

2D和3D矩阵研究线性侵袭体形成和活性

Cell adhesion, migration, and invasion are involved in many physiological and pathological processes. For example, during metastasis formation, tumor ...

Nanosensors to Detect Protease Activity In Vivo for Noninvasive Diagnostics

Nanosensors to Detect Protease Activity In Vivo for Noninvasive Diagnostics

纳米传感器检测体内蛋白酶活性的无创诊断

Proteases are multi-functional enzymes that specialize in the hydrolysis of peptide-bonds and control broad biological processes including homeostasis and ...

Manufacturing of a Nafion-coated, Reduced Graphene Oxide/Polyaniline Chemiresistive Sensor to Monitor pH in Real-time During Microbial Fermentation

在微生物发酵过程中制造一种纳菲安涂层、还原石墨烯 Oxide/Polyaniline 化学电阻传感器, 以实时监测 ph 值

Here, we report the engineering of a solid-state micro pH sensor based on polyaniline-functionalized, electrochemically reduced graphene oxide (ERGO-PA). ...

Colorimetric Analysis of Alkaline Phosphatase Activity in S. aureus Biofilm

Colorimetric Analysis of Alkaline Phosphatase Activity in S. aureus Biofilm

金黄色葡萄球菌生物膜碱性磷酸酶活性的比色法分析

Alkaline phosphatase (ALP) is a common enzyme expressed in both prokaryotic and eukaryotic cells. It catalyzes the hydrolysis of phosphate monoesters from ...

Design and Analysis for Fall Detection System Simplification

坠落检测系统简化的设计与分析

This paper presents a methodology based on multimodal sensors to configure a simple, comfortable and fast fall detection and human activity recognition ...