Duration and Timing of Supported TreadmilL Training

描述（由申请人提供）：体重支撑跑步机训练（BWSTT）是运动训练的一种治疗方式，正迅速被用于中风后的身体康复，以改善行走。虽然对这种治疗方式的有效性有初步的支持，但这种干预的最佳强度、频率和持续时间尚不清楚。卒中后何时给予这种干预最有效（如亚急性：卒中后< 1-3个月或慢性：卒中后1- 6个月）尚无证据。这项临床试验计划拨款的主要目的是组织一个有效的研究团队，并开发成功进行脑卒中后个体BWSTT随机临床试验（RCT）所需的要素。拟议的BWSTT临床试验将旨在评估：(1)最佳治疗时间（12 vs 24次训练），(2)治疗时间（中风后1 - 3个月vs中风后6个月），以及(3)运动障碍严重程度的影响。这一随机对照试验的成功实施有许多重要组成部分。具体而言，该计划拨款将(1)确定额外的合作者，(2)制定(a)实验设计和(b)干预方案，(3)选择并建立评估主要和次要结果测量的方案，（4a）确定临床有意义结果所需的效应大小和功率，（4b）建立分析计划，(5)建立数据协调/管理团队，(6)评估受试者招募策略的可行性。(7)选择排除和纳入标准，(8)制定竞争性干预措施的特征描述方法，(9)制定培训计划以确保干预措施在不同地点可复制，（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）制定管理随机对照试验的行政操作。临床试验计划拨款将使一个有组织、准备充分的研究团队准备好进行一项有效的随机对照试验，研究BWSTT的持续时间和时间，以及运动障碍严重程度对结果的影响。长期目标是通过提供临床实践指南，以科学证据为基础，为BWSTT在康复中的最佳使用提供改善中风后个体的行走能力。

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.