Cumplido-Trasmonte Carlos, Barquín-Santos Eva, Aneiros-Tarancón Fernando, Plaza-Flores Alberto, Espinosa-García Sandra, Fernández Roemi, García-Armada Elena
Marsi Bionics S.L., 28521 Madrid, Spain.
International Doctoral School, Rey Juan Carlos University, 28922 Madrid, Spain.
Children (Basel). 2024 Dec 10;11(12):1500. doi: 10.3390/children11121500.
the purpose of this study was to evaluate the safety and usability of the ATLAS 2030 in children with Cerebral Palsy (CP) and Spinal Muscular Atrophy (SMA).
the sample consisted of six children, three with CP and three with SMA, who received eight sessions of robot-assisted gait therapy. Safety was measured by the presence of adverse events. Usability was measured by spatiotemporal parameters, the Six-Minute Walking Test (6MWT), and the time needed for donning and doffing, as well as satisfaction questionnaires administered to therapists and patients.
no serious adverse events were reported. The average cadence and number of steps per session increased throughout sessions, as well as the distance covered in the 6MWT, both in participants with CP and SMA. The mean donning time at the end of the study was 4.6 ± 1.3 min, and only one therapist was necessary to carry out all of the sessions. Satisfaction was considered high by both children and therapists.
the ATLAS 2030 was shown to be safe for children with CP and SMA. The usability of the device was good, since a progression in the spatiotemporal parameters was observed throughout the sessions, and patient and therapist satisfaction were high.
本研究旨在评估ATLAS 2030对脑瘫（CP）和脊髓性肌萎缩症（SMA）患儿的安全性和可用性。
样本包括6名儿童，其中3名患有CP，3名患有SMA，他们接受了8次机器人辅助步态治疗。通过不良事件的发生情况来衡量安全性。通过时空参数、六分钟步行测试（6MWT）、穿戴和脱下所需时间以及向治疗师和患者发放的满意度调查问卷来衡量可用性。
未报告严重不良事件。在CP和SMA参与者中，整个治疗过程中平均步频和每次治疗的步数均增加，6MWT中的行走距离也增加。研究结束时的平均穿戴时间为4.6±1.3分钟，且所有治疗只需一名治疗师即可完成。儿童和治疗师的满意度均较高。
ATLAS 2030对CP和SMA患儿显示出安全性。该设备的可用性良好，因为在整个治疗过程中观察到时空参数有所改善，且患者和治疗师的满意度较高。
