Duration and Timing of Supported TreadmilL Training

描述(申请人提供)：体重支持的跑步机训练(BWSTT)是一种运动训练的治疗方式，正迅速被应用于身体康复以改善中风后的行走能力。虽然这种治疗方式的有效性得到了初步支持，但这种干预的最佳强度、频率和持续时间尚不清楚。缺乏证据表明，这种干预措施的实施在卒中后何时最有效(例如亚急性：卒中后1-3个月或慢性：卒中后6个月)。这项临床试验计划拨款的主要目的是组织一支有效的研究团队，开发成功进行中风后BWSTT随机临床试验(RCT)所必需的要素。BWSTT的拟议临床试验将旨在评估：(1)最佳治疗持续时间(12个培训课程与24个培训课程)，(2)提供治疗的时间(中风后1-3个月与中风后6个月)，以及(3)运动障碍严重程度的影响。要成功实施这一区域工作队，有许多基本要素。具体地说，这笔规划赠款将(1)确定更多的合作者，(2)制定(A)试验设计和(B)干预方案，(3)选择和建立用于评估主要和次要结果措施的方案，(4a)确定对临床有意义的结果所需的效果大小和力量，以及(4b)建立分析计划，(5)发展数据协调/管理小组，(6)评估受试者招募战略的可行性，(7)选择排除和纳入标准，(8)制定确定相互竞争的干预措施的方法，(9)制定培训计划，以确保干预措施可在不同地点复制，(10)为随机对照试验选择地点并获得机构审查委员会的批准，以及(11)制定行政操作来管理随机对照试验。临床试验计划拨款将使一个有组织和准备充分的研究团队准备好对BWSTT的持续时间和时间以及运动障碍的严重程度对结果的影响进行有效的随机对照试验。长期目标是通过提供基于科学证据的临床实践指南，为BWSTT在康复中的最佳使用提供临床实践指南，以提高中风后患者的行走能力。

DESCRIPTION (provided by applicant): Body-weight supported treadmill training (BWSTT) is one therapeutic modality for locomotor training that is rapidly being adopted into physical rehabilitation to improve walking after stroke. While there is preliminary support for the efficacy of this therapeutic modality, the optimal intensity, frequency, and duration for this intervention is not known. There is lack of evidence concerning when delivery of this intervention is most effective post-stroke (e.g. sub-acute: < 1-3 months post-stroke or chronic: > 6 months post-stroke). The primary aim of this clinical trial planning grant is to organize an effective research team and develop the elements essential for conducting a successful randomized clinical trial (RCT) of BWSTT in individuals post-stroke. The proposed clinical trial of BWSTT will be designed to assess: (1) the optimal treatment duration (12 vs. 24 training sessions), (2) the timing of treatment delivery (1 - 3 months post-stroke vs. > 6 months post-stroke), and (3) the effects of severity of locomotor impairments. There are many essential components for the successful implementation of this RCT. Specifically, this planning grant will (1) identify additional collaborators, (2) develop (a) the experimental design and (b) the intervention protocols, (3) select and establish protocols for assessing the primary and secondary outcome measures, (4a) determine the effect size and power needed for clinically meaningful results and (4b) establish an analysis plan, (5) develop a data coordination/management team, (6) assess the feasibility of subject recruitment strategies, (7) select exclusion and inclusion criteria, (8) develop methods to characterize competing interventions, (9) develop a training program to assure that the intervention is replicable across sites, (10) select sites for the RCT and attain Institutional Review Board approval, and (11) develop administrative operations to manage the RCT. The clinical trial planning grant will result in an organized and well-prepared research team ready to conduct an effective RCT of duration and timing of BWSTT and the effect of severity of locomotor impairment on outcomes. The long-term objective is to improve the ability to walk in individuals following stroke by providing clinical practice guidelines, based on scientific evidence, for the optimal use of BWSTT in rehabilitation.