Technical validation of real-world monitoring of gait: a multicentric observational study.
Technical validation of real-world monitoring of gait: a multicentric observational study.
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真实世界步态监测的技术验证：一项多中心观察研究。
DOI：
10.1136/bmjopen-2021-050785
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发表时间：
2021-12-02
期刊：
影响因子：
2.9
通讯作者：
Rochester L
中科院分区：
文献类型：
--
作者：
Mazzà C;Alcock L;Aminian K;Becker C;Bertuletti S;Bonci T;Brown P;Brozgol M;Buckley E;Carsin AE;Caruso M;Caulfield B;Cereatti A;Chiari L;Chynkiamis N;Ciravegna F;Del Din S;Eskofier B;Evers J;Garcia Aymerich J;Gazit E;Hansen C;Hausdorff JM;Helbostad JL;Hiden H;Hume E;Paraschiv-Ionescu A;Ireson N;Keogh A;Kirk C;Kluge F;Koch S;Küderle A;Lanfranchi V;Maetzler W;Micó-Amigo ME;Mueller A;Neatrour I;Niessen M;Palmerini L;Pluimgraaff L;Reggi L;Salis F;Schwickert L;Scott K;Sharrack B;Sillen H;Singleton D;Soltani A;Taraldsen K;Ullrich M;Van Gelder L;Vereijken B;Vogiatzis I;Warmerdam E;Yarnall A;Rochester L
基于功能表现、身体评估和患者自我报告的现有活动性终点通常受到缺乏敏感性的影响，限制了其在临床实践中的实用性。包括惯性测量单元（伊穆斯）在内的可穿戴设备可以通过在监督结构化评估期间和在现实世界条件下量化数字移动性结果（DMO）来克服这些限制。然而，基于IMU的方法在现实世界中的有效性在患者群体中仍然有限。严格的确认程序应涵盖器械的可接受性确认、针对感兴趣人群和日常生活情况的DMO计算算法确认以及用户对器械的看法。该方案旨在确定Mobilise-D用于量化真实的世界中数字移动性的方法的技术有效性和患者可接受性，Mobilise-D是由欧盟（EU）资助的联盟，作为创新医学计划的一部分，旨在促进DMO的监管批准和临床采用。在定义了基于IMU的设备的验证程序之后，给出了用于计算DMO的算法的验证实验程序。这些包括来自五组的120名参与者的实验室和真实世界评估：健康老年人;慢性阻塞性肺病，帕金森病，多发性硬化症，股骨近端骨折和充血性心力衰竭。将从监测装置中提取的目的地管理组织与根据观察背景选择的不同参考系统中的目的地管理组织进行比较。问卷和访谈将评估用户对所部署技术的看法以及流动性评估的相关性。该研究已获得中心委员会（伦敦-布卢姆斯伯里研究伦理委员会;赫尔辛基委员会;特拉维夫Sourasky医学中心;蒂宾根大学和基尔大学医学院）的伦理批准。数据和算法将公开提供。ISRCTN（12246987）。
Existing mobility endpoints based on functional performance, physical assessments and patient self-reporting are often affected by lack of sensitivity, limiting their utility in clinical practice. Wearable devices including inertial measurement units (IMUs) can overcome these limitations by quantifying digital mobility outcomes (DMOs) both during supervised structured assessments and in real-world conditions. The validity of IMU-based methods in the real-world, however, is still limited in patient populations. Rigorous validation procedures should cover the device metrological verification, the validation of the algorithms for the DMOs computation specifically for the population of interest and in daily life situations, and the users’ perspective on the device. This protocol was designed to establish the technical validity and patient acceptability of the approach used to quantify digital mobility in the real world by Mobilise-D, a consortium funded by the European Union (EU) as part of the Innovative Medicine Initiative, aiming at fostering regulatory approval and clinical adoption of DMOs. After defining the procedures for the metrological verification of an IMU-based device, the experimental procedures for the validation of algorithms used to calculate the DMOs are presented. These include laboratory and real-world assessment in 120 participants from five groups: healthy older adults; chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, proximal femoral fracture and congestive heart failure. DMOs extracted from the monitoring device will be compared with those from different reference systems, chosen according to the contexts of observation. Questionnaires and interviews will evaluate the users’ perspective on the deployed technology and relevance of the mobility assessment. The study has been granted ethics approval by the centre’s committees (London—Bloomsbury Research Ethics committee; Helsinki Committee, Tel Aviv Sourasky Medical Centre; Medical Faculties of The University of Tübingen and of the University of Kiel). Data and algorithms will be made publicly available. ISRCTN (12246987).
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影响因子：
3.7
作者：
Kluge F;Del Din S;Cereatti A;Gaßner H;Hansen C;Helbostad JL;Klucken J;Küderle A;Müller A;Rochester L;Ullrich M;Eskofier BM;Mazzà C;Mobilise-D consortium
通讯作者：
Mobilise-D consortium
DOI：
10.1098/rsta.2012.0085
发表时间：
2013-01-28
期刊：
Philosophical transactions. Series A, Mathematical, physical, and engineering sciences
影响因子：
--
作者：
Hiden H;Woodman S;Watson P;Cala J
通讯作者：
Cala J
影响因子：
5.5
作者：
Gao, Yiwen;Li, He;Luo, Yan
通讯作者：
Luo, Yan
DOI：
10.1093/gerona/57.4.m209
发表时间：
2002-04-01
影响因子：
5.1
作者：
Jette, AM;Haley, SM;Ashba, J
通讯作者：
Ashba, J
DOI：
10.1109/tim.2007.908635
发表时间：
2008-01-01
影响因子：
5.6
作者：
EI-Sheimy, Naser;Hou, Haiying;Niu, Xiaoji
通讯作者：
Niu, Xiaoji