Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.
DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.
ESC Heart Fail. 2022 Jun;9(3):1643-1650. doi: 10.1002/ehf2.13903. Epub 2022 Mar 23.
The aim of this pilot study was to investigate the safety, feasibility, tolerability, and acceptability of an assisted mobilization of advanced heart failure patients, using a lightweight, exoskeleton-type robot (Myosuit, MyoSwiss AG, Zurich, Switzerland).
Twenty patients in functional NYHA class III performed activities of daily life (ADL, n = 10) or participated in a single, standardized, 60 min rehabilitation exercise unit (REU, n = 10) with and without the Myosuit. The outcome assessment included the evaluation of vital signs, adverse events, rates of perceived exertion and dyspnoea (RPE, RPD), the ability to perform ADL or REU, and the individual acceptability. The mean age of the subjects was 49.4 (±11.0) years; 80% were male. The mean left ventricular ejection fraction was 22.1% (±7.4%) and the median NT-proBNP 2054 pg/mL (IQR 677, 3270 pg/mL). In all patients, mobilization with the Myosuit was feasible independently or with minor support. The mean individual difference in the total walking distance of the patients without and with robotic assistance was -26.5 m (95% confidence interval (CI) -142 to 78 m, P = 0.241). No adverse events occurred. RPE and RPD showed no significant difference with or without the device (ADL: RPE -0.1 m, 95% CI -1.42 to 1.62, P = 0.932 and RPD -0.95 m, 95% CI -0.38 to 2.28, P = 0.141; REU: RPE 1.1 m, 95% CI -2.90 to 0.70, P = 0.201 and RPD 0.5 m, 95% CI -2.02 to 1.02, P = 0.435). All median responses in the acceptability questionnaire were positive. The patients felt safe and enjoyed the experience; 85% would be interested in participating in robot-assisted training on a regular basis.
This feasibility pilot trial provides first indications that a robotic exoskeleton-assisted mobilization of patients with advanced heart failure is safe, feasible, well-tolerated, and well-accepted. The results are highly encouraging to further pursue this innovative approach in rehabilitation programmes. This trial was registered at ClinicalTrials.gov: NCT04839133.
本初步研究旨在探讨使用轻便的外骨骼型机器人(Myosuit,MyoSwiss AG,苏黎世,瑞士)辅助晚期心力衰竭患者进行移动的安全性、可行性、耐受性和可接受性。
20 名心功能纽约分级(NYHA)III 级的患者进行日常生活活动(ADL,n=10)或参加单次、标准化的 60 分钟康复运动单元(REU,n=10),并分别使用和不使用 Myosuit。结果评估包括生命体征、不良事件、感知用力程度(RPE)和呼吸困难程度(RPD)、进行 ADL 或 REU 的能力以及个体可接受性。受试者的平均年龄为 49.4(±11.0)岁;80%为男性。平均左心室射血分数为 22.1%(±7.4%),中位 NT-proBNP 为 2054pg/ml(IQR 677,3270pg/ml)。在所有患者中,使用 Myosuit 进行移动是可行的,无论是否有辅助均可。无机器人辅助和有机器人辅助时,患者总步行距离的平均个体差异为-26.5m(95%置信区间(CI)-142 至 78m,P=0.241)。未发生不良事件。有或没有该设备时,RPE 和 RPD 无显著差异(ADL:RPE-0.1m,95%CI-1.42 至 1.62,P=0.932;RPD-0.95m,95%CI-0.38 至 2.28,P=0.141;REU:RPE 1.1m,95%CI-2.90 至 0.70,P=0.201;RPD 0.5m,95%CI-2.02 至 1.02,P=0.435)。可接受性问卷的所有中位数回答均为阳性。患者感到安全并享受体验;85%的患者有兴趣定期参加机器人辅助训练。
这项可行性初步试验提供了初步证据,表明使用轻便的外骨骼型机器人辅助晚期心力衰竭患者进行移动是安全、可行、耐受良好且易于接受的。结果非常令人鼓舞,可以进一步在康复计划中采用这种创新方法。该试验已在 ClinicalTrials.gov 注册:NCT04839133。