Locomotor Experience Applied Post-Stroke (LEAPS)

描述(申请人提供)：使用体重支持和跑步机作为中风后步行康复的一种治疗方式的运动训练正迅速应用于临床实践。Cohrane最近的一项审查强调了迫切需要一项精心设计的试验来确定这种干预的有效性。运动体验应用后卒中(LEAPS)试验的拟议目标是进行一项为期5年、病期、单盲、多地点(5个临床地点)的随机临床试验(RCT)，以评估在卒中后2个月(LTP-早期)或卒中后6个月(LTP-晚期)提供的非特异性低强度运动(对照)干预与专门的运动训练计划(LTP)(包括使用体重支持和跑步机作为康复方式)之间，成功恢复步行能力的受试者比例是否存在差异。这项研究旨在成为一项明确的随机对照试验，其主要结果是中风后1年成功恢复行走(对于最初有严重步态障碍的人(&lt；0.4 m/S)步速达到或更快)，或者对于最初中度步态障碍的人(&gt；0.4 m/S；0.8 m/S)达到或更高的步速。我们还将确定LTP分娩的时机(早与晚)是否影响1年后步态速度的改善，以及最初的运动障碍严重程度是否与LTP分娩的时机相互作用。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18岁或以上的成年人，在中风后30天内发病，具有中到重度行走能力。在筛查和基线评估后，受试者将根据地面行走速度确定的基线运动损伤严重程度进行分层，并随机分配到3组中的一组：(A)LTP-早期；(B)LTP-晚期或(C)对照组。治疗次数的效果将取决于治疗前、治疗后12、24和36次治疗后步态速度的变化。我们的最终目标是提供证据来指导卒中后康复实践，减少卒中后患者的残疾。

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.