Locomotor Experience Applied Post-Stroke (LEAPS)

描述（由申请人提供）：使用体重支持和跑步机作为卒中后行走康复治疗方式的运动训练正在迅速应用于临床实践。最近的一项Cohrane综述强调迫切需要一个设计良好的试验来确定这种干预措施的有效性。卒中后运动经验应用（LEAPS）试验的拟定目标是进行一项为期5年的III期单盲研究，多站点（5家临床研究中心）随机临床试验（RCT），旨在评估专门的运动训练计划（LTP）包括使用体重支持和跑步机作为卒中后2个月（LTP-早期）或卒中后6个月（LTP-晚期）的康复方式，以及非特异性低强度运动（对照）干预。该研究设计为确定性随机对照试验，主要结局为卒中后1年步行的成功恢复（初始重度步态障碍（< 0.4 m/s）患者的步态速度达到0.4 m/s或更高，或初始中度步态障碍（> 0.4 m/s - < 0.8 m/s）患者的步态速度达到0.8 m/s或更高）。我们还将确定LTP交付的时间（早期与晚期）是否影响1年时步态速度的改善，以及初始运动障碍严重程度是否与LTP交付的时间相互作用。LTP和对照干预措施将在12周内进行36次会议。我们将招募400名年龄在18岁或以上的成年人，他们在卒中后30天内有中度至重度行走能力。筛选和基线评估后，将根据地上行走速度确定的基线运动障碍严重程度对受试者进行分层，并将受试者随机分配至3组之一：（a）LTP-早期;（B）LTP-晚期或（c）对照组。治疗次数的影响将通过治疗前、12次治疗后、24次治疗后和36次治疗后的步态速度变化来确定。我们的最终目标是提供证据，以指导脑卒中后的康复实践，减少残疾的人在脑卒中后。

DESCRIPTION (provided by applicant): Locomotor training using body weight support and a treadmill as a therapeutic modality for the rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. A recent Cohrane review highlighted the urgent need for a well-designed trial to determine the effectiveness of this intervention. The proposed objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to conduct a 5 year, phase-Ill, single-blind, multi-site (5 clinical sites) randomized clinical trial (RCT) to assess if there is a difference in the proportion of subjects who successfully recover walking ability between a specialized locomotor training program (LTP) that includes use of body weight support and a treadmill as a rehabilitation modality provided 2 months post-stroke (LTP-early) or 6 months post-stroke (LTP-late) and a non-specific, low intensity exercise (control) intervention. The study is designed to be a definitive RCT with the primary outcome being successful recovery of walking (achieving a 0.4 m/s gait speed or greater for persons with initial severe gait impairment (< 0.4 m/s) or as having achieved a 0.8 m/s gait speed or greater for persons with initial moderate gait impairment (> 0.4 m/s - < 0.8 m/s) at 1 year post-stroke. We will also determine if the timing of LTP delivery (early vs. late) affects the improvement in gait speed at 1 year and whether initial locomotor impairment severity interacts with the timing of LTP delivery. The LTP and control interventions will be delivered for 36 sessions over 12 weeks. We will recruit 400 adults, age 18 or older, within 30 days poststroke onset with moderate to severe walking ability. After screening and baseline assessment, subjects will be stratified by baseline locomotor impairment severity as determined by overground walking speed and randomly assigned to 1 of 3 groups: (a) LTP-Early; (b) LTP-Late or (c) Control. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment, post-12, post-24, and post-36 sessions. Our ultimate goal is to provide evidence to guide post-stroke rehabilitation practice and reduce disability in persons post-stroke.