Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial.
Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial.
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DOI：
10.1186/1471-2377-7-39
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发表时间：
2007-11-08
期刊：
影响因子：
2.6
通讯作者：
LEAPS Investigative Team
中科院分区：
文献类型：
--
作者：
Duncan PW;Sullivan KJ;Behrman AL;Azen SP;Wu SS;Nadeau SE;Dobkin BH;Rose DK;Tilson JK;LEAPS Investigative Team
使用体重支撑和跑步机的运动训练作为中风后步行康复的治疗方式正在迅速应用于临床实践。迫切需要一项精心设计的试验来确定这种干预措施的有效性。中风后应用运动经验 (LEAPS) 试验的目的是确定在中风后一年恢复步行能力的参与者比例是否存在差异，无论是随机分配到中风后 2 个月或 6 个月进行的专门运动训练计划 (LTP)，还是随机分配到中风后 2 个月提供的家庭非特异性低强度运动干预 (HEP)。我们将确定 LTP 实施的时间是否会影响 1 年时的步态速度，以及初始损伤严重程度是否与 LTP 的时间相互作用。治疗次数的效果将取决于治疗前以及 12、-24 和 -36 次治疗后步态速度的变化。我们将招募 400 名中风发病后 30 天内患有中度或重度行走受限的成年人。中风后两个月，根据地上行走速度确定的运动障碍严重程度对参与者进行分层，并随机分配到三组之一：（a）LTP-早期； (b) LTP-晚期或 (c) 家庭锻炼计划-早期。 LTP 计划包括跑步机上的体重支持和地上训练。 LTP 和 HEP 干预措施在 12 周内进行 36 次。主要结果指标包括成功行走恢复，定义为初始严重步态障碍者达到 0.4 m/s 或更高的步态速度，或初始中度步态障碍者达到 0.8 m/s 或更高的步态速度。 LEAPS 能够检测到 LTP 组和 HEP 组之间成功运动恢复的参与者比例存在 20% 的差异，以及两个 LTP 组之间步态速度变化的平均差异为 0.1 m/s。这项单盲、III 期随机临床试验的目标是提供证据来指导中风后步行恢复计划。 NCT00243919。
Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean difference in gait speed change between the two LTP groups. The goal of this single-blinded, phase III randomized clinical trial is to provide evidence to guide post-stroke walking recovery programs. NCT00243919.
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DOI：
10.1016/s0003-9993(95)80038-7
发表时间：
1995-01-01
影响因子：
4.3
作者：
JORGENSEN, HS;NAKAYAMA, H;OLSEN, TS
通讯作者：
OLSEN, TS
影响因子：
8.3
作者：
Duncan, PW;Samsa, GP;Matchar, D
通讯作者：
Matchar, D
DOI：
10.1016/s0003-9993(95)80567-2
发表时间：
1995-05-01
影响因子：
4.3
作者：
JORGENSEN, HS;NAKAYAMA, H;OLSEN, TS
通讯作者：
OLSEN, TS
影响因子：
--
作者：
FORSTER, A;YOUNG, J
通讯作者：
YOUNG, J
影响因子：
3
作者：
Eich, HJ;Mach, H;Hesse, S
通讯作者：
Hesse, S