Urrutia Rocío, Miren Gutiérrez-Muto Ane, Sanz-Morère Clara B, Gómez Arantxa, Politi Angela M, Lunardini Francesca, Baccini Marco, Cecchi Francesca, León Natacha, Oliviero Antonio, Tornero Jesús
Center for Clinical Neuroscience, Hospital Los Madroños, Madrid, Spain.
Joint PhD Program in Neuroscience, University of Castilla La Mancha, Albacete, Spain.
Front Neurorobot. 2023 Jul 5;17:1172770. doi: 10.3389/fnbot.2023.1172770. eCollection 2023.
The objective of this study is to verify the reliability and the concurrent and discriminant validity of the measurements of spasticity offered by the robotic device, quantifying the (1) test-retest reliability, (2) correlation with the clinical evaluation using the Modified Ashworth Scale (MAS), (3) inter-rater reliability between the two physiotherapists, and (4) ability to discriminate between healthy and stroke patients.
A total of 20 stroke patients and 20 healthy volunteers participated in the study. Two physical therapists (PT1 and PT2) independently evaluated the hand spasticity of stroke subjects using the MAS. Spasticity was assessed, both in healthy and stroke patients, with the Amadeo device at three increasing velocities of passive movement for three consecutive repeated assessments, while raw data of force and position were collected through an external program.
The intraclass correlation coefficient (ICC) and the weighted kappa were computed to estimate the reliability of the Amadeo device measurements, the inter-rater reliability of MAS, and the correlation between the MAS and Amadeo device measurements. The discriminant ability of the Amadeo device was assessed by comparing the stroke and healthy subjects' spasticity measurements with the percentage of agreements with 0 in MAS for healthy subjects.
The test-retest reliability of the Amadeo device was high with ICC at all three velocities (ICC = 0.908, 0.958, and 0.964, respectively) but lower if analyzed with weighted kappa correlation (0.584, 0.748, and 0.749, respectively) as mean values for each velocity. The correlation between Amadeo and the clinical scale for stroke patients with weighted kappa correlation was poor (0.280 ± 0.212 for PT1 and 0.290 ± 0.155 for PT2). The inter-rater reliability of the clinical MAS was high (ICC = 0.911).
Both MAS and Amadeo spasticity scores showed good reliability. The Amadeo scores did not show a strong clinical correlation with the MAS in stroke patients. Hitherto, Amadeo evaluation shows trends that are consistent with the characteristics of spasticity, such as an increase in spasticity as the speed of muscle stretching increases. The ability of the device to discriminate between stroke patients and healthy controls is low. Future studies adopting an instrumental gold standard for spasticity may provide further insight into the validity of these measurements.
本研究的目的是验证机器人设备所提供的痉挛测量的可靠性、同时效度和区分效度，量化（1）重测信度，（2）与使用改良Ashworth量表（MAS）进行的临床评估的相关性，（3）两名物理治疗师之间的评分者间信度，以及（4）区分健康人和中风患者的能力。
共有20名中风患者和20名健康志愿者参与了本研究。两名物理治疗师（PT1和PT2）使用MAS独立评估中风受试者的手部痉挛情况。在健康人和中风患者中，使用阿玛迪奥设备在三种逐渐增加的被动运动速度下进行连续三次重复评估来评估痉挛情况，同时通过外部程序收集力和位置的原始数据。
计算组内相关系数（ICC）和加权kappa值，以估计阿玛迪奥设备测量的可靠性、MAS的评分者间信度以及MAS与阿玛迪奥设备测量之间的相关性。通过比较中风患者和健康受试者的痉挛测量结果以及健康受试者在MAS中与0的一致性百分比，评估阿玛迪奥设备的区分能力。
阿玛迪奥设备在所有三种速度下的重测信度都很高，ICC分别为0.908、0.958和0.964，但如果用加权kappa相关性分析，作为每种速度的平均值则较低（分别为0.584、0.748和0.749）。对于中风患者，阿玛迪奥设备与临床量表之间的加权kappa相关性较差（PT1为0.280±0.212，PT2为0.290±0.155）。临床MAS的评分者间信度很高（ICC = 0.911）。
MAS和阿玛迪奥痉挛评分均显示出良好的可靠性。在中风患者中，阿玛迪奥评分与MAS没有很强的临床相关性。迄今为止，阿玛迪奥评估显示出与痉挛特征一致的趋势，例如随着肌肉拉伸速度的增加痉挛加剧。该设备区分中风患者和健康对照的能力较低。未来采用痉挛测量工具金标准的研究可能会进一步深入了解这些测量的效度。
