Locomotor Experience Applied Post-Stroke (LEAPS)

描述（由申请人提供）：使用体重支撑和跑步机进行运动训练，作为中风后步行康复的一种治疗方式，正在迅速应用于临床实践。最近的一篇Cohrane综述强调，迫切需要一项设计良好的试验来确定这种干预措施的有效性。卒中后运动体验应用（LEAPS）试验的拟议目标是开展一项为期5年，i期，单盲，多地点（5个临床地点）随机临床试验（RCT），以评估在中风后2个月（LTP早期）或6个月（LTP晚期）和非特异性、低强度运动（对照）干预下，专业运动训练计划（LTP）包括使用体重支持和跑步机作为康复方式，成功恢复行走能力的受试者比例是否存在差异。该研究旨在成为一项明确的随机对照试验，其主要结果是卒中后1年成功恢复行走（对于初始严重步态障碍（< 0.4 m/s）的患者达到0.4 m/s或更高的步态速度或对于初始中度步态障碍（> 0.4 m/s - < 0.8 m/s）的患者达到0.8 m/s或更高的步态速度）。我们还将确定LTP交付的时间（早或晚）是否会影响1岁时步态速度的改善，以及初始运动障碍的严重程度是否与LTP交付的时间相互作用。LTP和控制干预措施将在12周内进行36次会议。我们将招募400名成年人，年龄在18岁或以上，卒中后30天内具有中度至重度行走能力。筛选和基线评估后，受试者将根据地面行走速度确定的基线运动障碍严重程度进行分层，并随机分为3组：(a) LTP-Early；(b) LTP-Late或(c) Control。治疗次数的影响将通过治疗前、12次后、24次后和36次后的步态速度变化来确定。我们的最终目标是为指导脑卒中后康复实践和减少脑卒中后患者的残疾提供证据。

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.