Duration and Timing of Supported TreadmilL Training

描述（由申请人提供）：体重支持跑步机训练（BWSTT）是一种运动训练的治疗方式，正迅速被用于身体康复，以改善中风后的行走。虽然这种治疗方式的疗效得到了初步支持，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，卒中后何时进行这种干预最有效（例如亚急性：< 1-3 months post-stroke or chronic: >卒中后6个月）。该临床试验计划补助金的主要目的是组织一个有效的研究团队，并开发在卒中后个体中成功进行BWSTT随机临床试验（RCT）所必需的要素。拟定的BWSTT临床试验将设计用于评估：（1）最佳治疗持续时间（12 vs. 24次训练），（2）治疗时间（卒中后1 - 3个月vs.卒中后&gt; 6个月），以及（3）运动障碍严重程度的影响。成功实施这项随机对照试验有许多基本要素。具体而言，该计划补助金将（1）确定其他合作者，（2）开发（a）实验设计和（B）干预方案，（3）选择和建立用于评估主要和次要结局指标的方案，（4 a）确定有临床意义结果所需的效应大小和功效，（4 B）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）选择排除和入选标准，（8）制定方法来描述竞争性干预措施，（9）制定培训计划，以确保干预措施可在各研究中心复制，（10）选择RCT研究中心并获得机构审查委员会批准，（11）制定管理RCT的行政操作。临床试验规划补助金将导致一个有组织和准备充分的研究团队准备进行有效的RCT的持续时间和时间的BWSTT和运动障碍的严重程度对结果的影响。长期目标是通过提供基于科学证据的临床实践指南来改善卒中后个体的行走能力，以最佳地使用BWSTT进行康复。

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.