Tam Pui Kit, Tang Ning, Kamsani Nur Shafawati Binte, Yap Thian Yong, Coffey-Aladdin Ita, Goh Shi Min, Tan Jean Pei Pei, Lui Yook Cing, Lee Rui Ling, Suresh Ramaswamy, Chew Effie
Division of Rehabilitation Medicine, Department of Medicine, National University Hospital, Singapore, Singapore.
Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
J Neuroeng Rehabil. 2025 Jan 6;22(1):3. doi: 10.1186/s12984-024-01536-1.
Despite the reported efficacy of overground robotic exoskeleton (ORE) for rehabilitation of mobility post-stroke, its effectiveness in real-world practice is still debated. We analysed prospectively collected data from Improving Mobility Via Exoskeleton (IMOVE), a multicentre clinical implementation programme of ORE enrolling participants with various neurological conditions and were given options to choose between 12 sessions of ORE or conventional therapy (control).
This is analysis of participants under IMOVE who fulfilled the following criteria (i) primary diagnosis was stroke (ischemic, hemorrhagic; first or recurrent), (ii) onset of stroke was within 9 months and (iii) the intervention was during inpatient stay. They should also fulfill the general IMOVE inclusion and exclusion criteria which were resembling general clinical and manufacturing criteria of ORE. Outcome measures included Functional Ambulatory Category (FAC), Rivermead Mobility Index (RMI), Functional Independence Measure (FIM) and Clinical Outcome Variable Scale (COVS), measured immediately before and after the 12 sessions of therapy, and mean distance walked per session.
Of 149 participants (105 OREs and 44 controls), both groups improved significantly in motor outcomes with no significant between-group differences. Participants with baseline FAC 1 had significantly greater improvement in motor sub-score of FIM (FIM-motor) compared to controls (mean difference 8.4, 95% CI 0.65-16.07, η = 0.136, p = 0.034). The mean distance walked per session for ORE group was almost three times that of control for those with baseline FAC 0 (121.5 [SD 31.1]m vs 35.0 [SD 41.0]m, 95% CI 62.2-110.9, d = 2.54 p < 0.001) and FAC 1 (145.8 [SD 31.6]m vs 52.2 [SD 42.5]m, 95% CI 61.8-125.2, d = 2.71, p < 0.001). The difference was not observed for FAC 2 to 3 (162.9 [SD 29.2]m vs 134.2 [SD 87.5]m, 95% CI -22.2 to 79.7, d = 0.41, p = 0.252).
In a pragmatic setting, use of ORE for gait training enabled patients with lower ambulatory capacity to walk longer distances during therapy sessions. Patients who required continuous assistance during ambulation (FAC 1) had significantly better gains in FIM-motor compared to conventional therapy, suggesting possible benefit of ORE for this group.
The trial was registered with clinicaltrials.gov (NCT05659121) on April 14, 2022.
尽管有报道称地面机器人外骨骼（ORE）对中风后运动功能康复有效，但其在实际临床中的效果仍存在争议。我们前瞻性分析了“通过外骨骼改善运动能力（IMOVE）”项目收集的数据，该项目是一项ORE多中心临床应用计划，纳入了患有各种神经系统疾病的参与者，并让他们在接受12次ORE治疗或传统治疗（对照组）之间进行选择。
对IMOVE项目中符合以下标准的参与者进行分析：（i）主要诊断为中风（缺血性、出血性；首次或复发），（ii）中风发病时间在9个月内，（iii）干预在住院期间进行。他们还应符合IMOVE的一般纳入和排除标准，这些标准类似于ORE的一般临床和生产标准。结局指标包括功能步行分类（FAC）、里弗米德运动指数（RMI）、功能独立性测量（FIM）和临床结局变量量表（COVS），在12次治疗前后立即测量，以及每次治疗的平均步行距离。
在149名参与者（105名接受ORE治疗，44名作为对照）中，两组的运动结局均有显著改善，组间差异无统计学意义。与对照组相比，基线FAC为1的参与者在FIM运动子评分（FIM - motor）上有显著更大的改善（平均差异8.4，95%置信区间0.65 - 16.07，η = 0.136，p = 0.034）。对于基线FAC为0的参与者，ORE组每次治疗的平均步行距离几乎是对照组的三倍（121.5[标准差31.1]米对35.0[标准差41.0]米，95%置信区间62.2 - 110.9，d = 2.54，p < 0.001），FAC为1的参与者也是如此（145.8[标准差31.6]米对52.2[标准差42.5]米，95%置信区间61.8 - 125.2，d = 2.71，p < 0.001）。FAC为2至3的参与者未观察到差异（162.9[标准差29.2]米对134.2[标准差87.5]米，95%置信区间 - 22.2至79.7，d = 0.41，p = 0.252）。
在实际临床环境中，使用ORE进行步态训练可使步行能力较低的患者在治疗期间行走更长的距离。与传统治疗相比，在行走时需要持续辅助（FAC为1）的患者在FIM - motor方面有显著更好的改善，表明ORE对该组患者可能有益。
该试验于2022年4月14日在clinicaltrials.gov（NCT05659121）注册。
