基于二维平面手臂康复机器人的远程康复治疗：一项针对偏瘫脑卒中患者的临床至家庭运动游戏疗法的可行性研究。

Telerehabilitation using a 2-D planar arm rehabilitation robot for hemiparetic stroke: a feasibility study of clinic-to-home exergaming therapy.

机构信息

Articares Pte Ltd, 67, Ayer Rajah Crescent, #07-11/12, Singapore, 139950, Singapore.

Institute of Rehabilitation Excellence (IREx), Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.

出版信息

J Neuroeng Rehabil. 2024 Nov 26;21(1):207. doi: 10.1186/s12984-024-01496-6.

DOI:10.1186/s12984-024-01496-6

PMID:39593101

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11590240/

Abstract

BACKGROUND

We evaluated the feasibility, safety, and efficacy of a 2D-planar robot for minimally supervised home-based upper-limb therapy for post-stroke hemiparesis.

METHODS

The H-Man, end effector robot, combined with web-based software application for remote tele-monitoring were evaluated at homes of participants. Inclusion criteria were: strokes > 28 days, Fugl-Meyer Motor Assessment (FMA) > 10-60/66, presence of a carer and absence of medical contraindications. Participants performed self-directed, minimally supervised robotics-assisted therapy (RAT) at home for 30 consecutive days, after 2 therapist-supervised clinic on-boarding sessions. Web-based compliance measures were: accessed sessions of > 20 min/day, training minutes/day and active training hours/30 days. Clinical outcomes at weeks 0, 5 (post-training), 12 and 24 (follow-up) consisted of FMA, Action Research Arm Test (ARAT) and WHO-Stroke Specific Quality of Life (SSQOL). To estimate immediate economic benefits of the home-based robotic therapy, we performed cost-effectiveness analysis (CEA), followed by budget impact analysis (BIA).

RESULTS

Altogether, all 12 participants completed Home-RAT without adverse events; 9 (75.0%) were males, mean (SD) age, 59.4 years (9.5), median (IQR) stroke duration 38.6 weeks (25.4, 79.6) baseline FMA (0-66) 42.1 ± 13.2, ARAT (0-57) 25.4 ± 19.5, SSQOL (0-245) 185.3 ± 32.8. At week 5 follow-up, mean (SD) accessed days were 26.3 days ± 6.4, active training hours of 35.3 h ± 14.7/30 days, or ~ 6 days/week and 77 training minutes ± 20.9/day were observed. Significant gains were observed from baseline across time; ΔFMA 2.4 at week 5 (FMA 44.5, CI 95% 39.7-49.3, p < 0.05) and ΔFMA 3.7 at week 24 (FMA 45.8, CI 95% 40.5-51, p < 0.05); ΔARAT 2.6 at week 5 (ARAT 28.0, CI 95% 19.3-36.7, p < 0.05), and ΔARAT 4.8 at week 24 (ARAT 30.2, CI 95% 21.2-39.1, p < 0.05). At week 5 follow-up, 91% of participants rated their overall experience as satisfied or very satisfied. Incremental CEA observed savings of -S$144/per cure over 24 weeks, BIA-potentially 12% impact reduction over five years.

CONCLUSIONS

This study demonstrates the feasibility, acceptability, safety, clinical efficacy, and cost-effectiveness of a home-based, web-enabled telemonitored carer-supervised robotics-aided therapy.

TRIAL REGISTRATION

NCT05212181 ( https://clinicaltrials.gov ).

摘要

背景

我们评估了一种 2D 平面机器人在家庭环境中对脑卒中后偏瘫患者进行最小监督的上肢康复治疗的可行性、安全性和疗效。

方法

在参与者家中评估了 H-Man 末端效应器机器人与基于网络的远程远程监控软件应用程序的结合。纳入标准为：卒中后>28 天，Fugl-Meyer 运动评估（FMA）>10-60/66，有护理人员和无医疗禁忌证。参与者在 2 次治疗师监督的门诊启动课程后，在家中进行自我指导的最小监督机器人辅助治疗（RAT），连续 30 天。基于网络的依从性测量包括：每天访问>20 分钟的会话、训练分钟/天和每天活动训练小时/30 天。治疗后第 0、5（训练后）、12 和 24 周（随访）的临床结果包括 FMA、动作研究上肢测试（ARAT）和世界卫生组织卒中特定生活质量量表（SSQOL）。为了估计家庭机器人治疗的直接经济效益，我们进行了成本效益分析（CEA），随后进行了预算影响分析（BIA）。

结果

共有 12 名参与者在家中完成了 RAT，没有不良事件；9 名（75.0%）为男性，平均（SD）年龄 59.4 岁（9.5），中位数（IQR）卒中持续时间 38.6 周（25.4，79.6），基线 FMA（0-66）为 42.1±13.2，ARAT（0-57）为 25.4±19.5，SSQOL（0-245）为 185.3±32.8。在第 5 周随访时，平均（SD）访问天数为 26.3 天±6.4，每天活动训练小时为 35.3 小时±14.7/30 天，即每周约 6 天和每天 77 分钟训练±20.9/天。与基线相比，所有时间都有显著的改善；第 5 周时 FMA 增加 2.4（FMA 44.5，95%CI 39.7-49.3，p<0.05），第 24 周时 FMA 增加 3.7（FMA 45.8，95%CI 40.5-51，p<0.05）；第 5 周时 ARAT 增加 2.6（ARAT 28.0，95%CI 19.3-36.7，p<0.05），第 24 周时 ARAT 增加 4.8（ARAT 30.2，95%CI 21.2-39.1，p<0.05）。在第 5 周随访时，91%的参与者对他们的整体体验表示满意或非常满意。增量 CEA 观察到在 24 周内节省了每例治疗-144 新元，BIA-潜在地在五年内减少了 12%的影响。