Kolářová Barbora, Šaňák Daniel, Hluštík Petr, Kolář Petr
Department of Rehabilitation, University Hospital Olomouc, I.P. Pavlova 6, 779 00 Olomouc, Czech Republic.
Department of Neurology, Faculty of Medicine and Dentistry, Palacký University Olomouc and University Hospital Olomouc, 779 00 Olomouc, Czech Republic.
Brain Sci. 2022 Dec 3;12(12):1661. doi: 10.3390/brainsci12121661.
The GAITFAST study (gait recovery in patients after acute ischemic stroke) aims to compare the effects of treadmill-based robot-assisted gait training (RTGT) and therapist-assisted treadmill gait training (TTGT) added to conventional physical therapy in first-ever ischemic stroke patients. GAITFAST (Clinicaltrials.gov identifier: NCT04824482) was designed as a single-blind single-center prospective randomized clinical trial with two parallel groups and a primary endpoint of gait speed recovery up to 6 months after ischemic stroke. A total of 120 eligible and enrolled participants will be randomly allocated (1:1) in TTGT or RTGT. All enrolled patients will undergo a 2-week intensive inpatient rehabilitation including TTGT or RTGT followed by four clinical assessments (at the beginning of inpatient rehabilitation 8-15 days after stroke onset, after 2 weeks, and 3 and 6 months after the first assessment). Every clinical assessment will include the assessment of gait speed and walking dependency, fMRI activation measures, neurological and sensorimotor impairments, and gait biomechanics. In a random selection (1:2) of the 120 enrolled patients, multimodal magnetic resonance imaging (MRI) data will be acquired and analyzed. This study will provide insight into the mechanisms behind poststroke gait behavioral changes resulting from intensive rehabilitation including assisted gait training (RTGT or TTGT) in early subacute IS patients.
GAITFAST研究（急性缺血性中风患者的步态恢复）旨在比较在首次发生缺血性中风的患者中，基于跑步机的机器人辅助步态训练（RTGT）和治疗师辅助跑步机步态训练（TTGT）加常规物理治疗的效果。GAITFAST（Clinicaltrials.gov标识符：NCT04824482）被设计为一项单盲单中心前瞻性随机临床试验，有两个平行组，主要终点是缺血性中风后6个月内的步态速度恢复。总共120名符合条件并已入组的参与者将被随机分配（1:1）到TTGT组或RTGT组。所有入组患者将接受为期2周的强化住院康复治疗，包括TTGT或RTGT，随后进行四次临床评估（在住院康复开始时、中风发作后8 - 15天、2周后以及首次评估后的3个月和6个月）。每次临床评估将包括步态速度和步行依赖程度的评估、功能磁共振成像激活测量、神经和感觉运动障碍以及步态生物力学评估。在120名入组患者中随机选取（1:2），将采集并分析多模态磁共振成像（MRI）数据。本研究将深入了解早期亚急性缺血性中风患者在接受包括辅助步态训练（RTGT或TTGT）在内的强化康复治疗后，中风后步态行为变化背后的机制。
