Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial.
Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial.
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DOI：
10.1186/s12984-021-00942-z
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发表时间：
2021-10-10
影响因子：
5.1
通讯作者：
Eng JJ
中科院分区：
文献类型：
--
作者：
Louie DR;Mortenson WB;Durocher M;Schneeberg A;Teasell R;Yao J;Eng JJ
在亚急性卒中康复期间，需要更多物理辅助来练习行走的个体完成的物理治疗步骤较少。已经开发了动力外骨骼以允许下肢无力的个体进行重复的地上步态训练。本研究的目的是确定在亚急性康复期间，基于Exobronon的物理治疗训练对中风卧床患者步行恢复的疗效。 在3家住院康复医院进行了一项评估者盲法随机对照试验。患有亚急性卒中（< 3个月）的患者在没有实质性帮助的情况下无法行走（功能性Ambassador分类评分为0或1），在康复期间随机接受基于exoblonon或标准物理治疗，直至出院或最多8周。该实验方案用个性化的基于exopronon的疗程取代了75%的标准物理治疗疗程，以增加站立和踏步的重复性，并有可能脱离设备。主要结果是步行能力，使用功能性Ambassador分类进行测量。次要结局为步态速度、6分钟步行试验行走距离、达到无辅助步态的天数、下肢运动功能（Fugl-Meyer评估）、贝格平衡量表、患者健康问卷、蒙特利尔认知评估和36项简表调查，在干预后和6个月后进行测量。 36例卒中患者（卒中后平均39天）接受随机分组（Exoskeleton = 19例，Medial Care = 17例）。在意向治疗分析中，在干预后或6个月后的主要或次要结局中未发现显著的组间差异。随机分配至外骨骼组的5名受试者未按计划接受方案，因此进行了探索性实际治疗和符合方案分析。经治疗分析发现，坚持基于exobronon的物理治疗的患者在6个月时更早恢复独立行走（p = 0.03），步态速度（p = 0.04）和6 MWT（p = 0.03）更大;然而，这些差异在符合方案分析中并不显著。未报告严重不良事件。这项研究发现，基于exoadenon的物理治疗不会比标准护理更大地改善行走独立性，但可以安全地进行，不会损害患者的预后。临床试验注册外骨骼用于卒中后Ambassador恢复（ExStRA）试验已在ClinicalTrials.gov注册（NCT 02995265，首次注册：2016年12月16日）
Individuals requiring greater physical assistance to practice walking complete fewer steps in physical therapy during subacute stroke rehabilitation. Powered exoskeletons have been developed to allow repetitious overground gait training for individuals with lower limb weakness. The objective of this study was to determine the efficacy of exoskeleton-based physical therapy training during subacute rehabilitation for walking recovery in non-ambulatory patients with stroke. An assessor-blinded randomized controlled trial was conducted at 3 inpatient rehabilitation hospitals. Patients with subacute stroke (< 3 months) who were unable to walk without substantial assistance (Functional Ambulation Category rating of 0 or 1) were randomly assigned to receive exoskeleton-based or standard physical therapy during rehabilitation, until discharge or a maximum of 8 weeks. The experimental protocol replaced 75% of standard physical therapy sessions with individualized exoskeleton-based sessions to increase standing and stepping repetition, with the possibility of weaning off the device. The primary outcome was walking ability, measured using the Functional Ambulation Category. Secondary outcomes were gait speed, distance walked on the 6-Minute Walk Test, days to achieve unassisted gait, lower extremity motor function (Fugl-Meyer Assessment), Berg Balance Scale, Patient Health Questionnaire, Montreal Cognitive Assessment, and 36-Item Short Form Survey, measured post-intervention and after 6 months. Thirty-six patients with stroke (mean 39 days post-stroke) were randomized (Exoskeleton = 19, Usual Care = 17). On intention-to-treat analysis, no significant between-group differences were found in the primary or secondary outcomes at post-intervention or after 6 months. Five participants randomized to the Exoskeleton group did not receive the protocol as planned and thus exploratory as-treated and per-protocol analyses were undertaken. The as-treated analysis found that those adhering to exoskeleton-based physical therapy regained independent walking earlier (p = 0.03) and had greater gait speed (p = 0.04) and 6MWT (p = 0.03) at 6 months; however, these differences were not significant in the per-protocol analysis. No serious adverse events were reported. This study found that exoskeleton-based physical therapy does not result in greater improvements in walking independence than standard care but can be safely administered at no detriment to patient outcomes. Clinical Trial Registration The Exoskeleton for post-Stroke Recovery of Ambulation (ExStRA) trial was registered at ClinicalTrials.gov (NCT02995265, first registered: December 16, 2016)
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影响因子：
5.1
作者：
Calabro, Rocco Salvatore;Naro, Antonino;Bramanti, Alessia
通讯作者：
Bramanti, Alessia
影响因子：
3.5
作者：
Bijleveld-Uitman, Merel;van de Port, Ingrid;Kwakkel, Gert
通讯作者：
Kwakkel, Gert
影响因子：
8.3
作者：
Jarvis, Hannah L.;Brown, Steven J.;Reeves, Neil D.
通讯作者：
Reeves, Neil D.
影响因子：
4.2
作者：
Hsu CJ;Kim J;Roth EJ;Rymer WZ;Wu M
通讯作者：
Wu M
影响因子：
2
作者：
Fulk, George D.;Echternach, John L.;O'Sullivan, Susan
通讯作者：
O'Sullivan, Susan