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评估慢性免疫介导性神经病中的手部运动功能:一项使用数据手套的概念验证研究。

Assessing hand motor function in chronic immune-mediated neuropathies: a proof-of-concept study using a data glove.

作者信息

Gilliam Elisa, Achenbach Pascal, Suemmermann Gernot J, Wessely Manuel N, Rossmanith Peter, Dohrn Maike F, Schulz Jörg B, Waschbisch Anne, Brunkhorst Robert

机构信息

Department of Neurology, RWTH Aachen University Hospital, Pauwelsstrasse 30, 52074, Aachen, Germany.

Institute of Neuropathology, RWTH Aachen University Hospital, Aachen, Germany.

出版信息

J Neuroeng Rehabil. 2024 Dec 20;21(1):218. doi: 10.1186/s12984-024-01518-3.

Abstract

BACKGROUND

Chronic immune-mediated neuropathies are clinically heterogeneous and require regular, objective, and multidimensional monitoring to individualize treatment. However, established outcome measures are insufficient regarding measurement quality criteria (e.g., reliability, objectivity) or functional relevance. Wearables such as data gloves might be helpful, allowing repeated quantification of complex everyday life-relevant motor function of the hand.

METHODS

25 patients with chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy were followed-up at five time points during maintenance therapy with intravenous immunoglobulin. 14 of them showed clinically relevant hand motor impairment. We examined the patients' hand function using a data glove which quantifies the active range of motion (ROM) of the hand based on three different movement patterns. In addition, clinical outcome parameters (grip strength measurement, MRC Sum Score, INCAT disability score), nerve conduction studies (NCS), and high-resolution ultrasound (HRUS) were performed, and patient-reported outcome measures (PROMs) like the Rasch-built Overall Disability Scale (R-ODS) were assessed. We calculated correlation coefficients, performed Receiver Operating Characteristic analysis, as well as correlation analyses for the glove data and clinical outcome parameters. Longitudinal analyses were based on a Linear Mixed Model, and we assessed construct validity of the data glove by analyzing correlations between the glove measurements and well-established clinical parameters.

RESULTS

We found good to excellent test-retest reliability for the ROM in all glove movement patterns (Intraclass correlation coefficients = 0.83-0.94), underlining the ability to capture clinical stability. Moreover, the glove demonstrated adequate, sensitivity and specificity in detecting hand motor impairment (area under the curve (AUC): 0.714-0.780), and it performed better than NCS and HRUS (AUC: 0.552/0.701). The AUC values for the metrically scaled parameters include: Vigorimeter (AUC: 0.929) and R-ODS (AUC: 0.698). Additionally, the data glove proved to be a valid tool, as we demonstrated moderate to strong, significant correlations between the glove and established clinical parameters (especially Vigorimeter), as well as PROMs (especially R-ODS).

CONCLUSIONS

This data glove allowed for a non-invasive assessment of the hand motor function and yielded investigator-independent results that reliably reflected individual functional deficits with relevance to everyday life. Future studies should explore the ability to predict clinically meaningful responses to immunomodulatory treatment and to support and monitor rehabilitation progress, with potential applications in other neurological diseases as well. Trial registration at the German Clinical Trials Register, Deutsches Register Klinischer Studien (DRKS: 00027345), retrospectively registered on 23rd March 2022: https://drks.de/search/de/trial/DRKS00027345.

摘要

背景

慢性免疫介导性神经病在临床上具有异质性,需要进行定期、客观和多维度的监测以实现个体化治疗。然而,既定的疗效指标在测量质量标准(如可靠性、客观性)或功能相关性方面存在不足。数据手套等可穿戴设备可能会有所帮助,它能够对与日常生活相关的手部复杂运动功能进行反复量化。

方法

25例慢性炎症性脱髓鞘性多发性神经病或多灶性运动神经病患者在接受静脉注射免疫球蛋白维持治疗期间的五个时间点接受随访。其中14例存在临床上相关的手部运动障碍。我们使用数据手套检查患者的手部功能,该手套基于三种不同的运动模式对手部的主动活动范围(ROM)进行量化。此外,还进行了临床结局参数(握力测量、医学研究委员会(MRC)总分、INCAT残疾评分)、神经传导研究(NCS)和高分辨率超声(HRUS)检查,并评估了患者报告的结局指标(PROMs),如Rasch构建的总体残疾量表(R-ODS)。我们计算了相关系数,进行了受试者工作特征分析,以及手套数据与临床结局参数之间的相关性分析。纵向分析基于线性混合模型,我们通过分析手套测量值与成熟的临床参数之间的相关性来评估数据手套的结构效度。

结果

我们发现所有手套运动模式下ROM的重测信度良好至优秀(组内相关系数=0.83-0.94),这突出了其捕捉临床稳定性的能力。此外,该手套在检测手部运动障碍方面表现出足够的敏感性和特异性(曲线下面积(AUC):0.714-0.780),并且其表现优于NCS和HRUS(AUC:分别为0.552/0.701)。度量缩放参数的AUC值包括:握力计(AUC:0.929)和R-ODS(AUC:0.698)。此外,数据手套被证明是一种有效的工具,因为我们证明了手套与既定临床参数(尤其是握力计)以及PROMs(尤其是R-ODS)之间存在中度至高度的显著相关性。

结论

这种数据手套能够对手部运动功能进行非侵入性评估,并产生与研究者无关的结果,这些结果可靠地反映了与日常生活相关的个体功能缺陷。未来的研究应探索预测对免疫调节治疗的临床有意义反应以及支持和监测康复进展的能力,其在其他神经系统疾病中也具有潜在应用价值。在德国临床试验注册中心(German Clinical Trials Register, Deutsches Register Klinischer Studien, DRKS)进行的试验注册,注册号为DRKS: 00027345,于2022年3月23日进行追溯注册:https://drks.de/search/de/trial/DRKS00027345

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b80/11662497/85d47dcefb52/12984_2024_1518_Fig1_HTML.jpg

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