LOCOMOTOR THERAPY TRIAL FOR SPINAL CORD INJURY

创伤性脊髓损伤（SCI）后，自主活动能力的恢复是患者康复过程中最重要的目标之一。大多数人将无法恢复行走能力，或者步履缓慢，耗费大量能量，妨碍了社区的流动性。在改善运动功能独立性或最大化步行速度方面，没有哪一种康复策略比另一种更好。我们提出了第一个多中心随机临床试验（RCT）的任务导向运动干预急性脊髓损伤。该策略应用了腰骶神经回路和协调腿部运动的棘上神经元中使用依赖运动学习的基础神经科学研究和试点临床研究。这种干预被称为体重支撑跑步机训练（BWSTT），它通过头顶的升降机连接到受试者佩戴的安全带来部分支撑患者的体重。然后，治疗师可以系统地训练患者在跑步机上以越来越快的速度在更少的重量支持下行走。他们纠正步态偏差和操纵感官输入，加强控制的立场和摇摆阶段的行走。在拟议的试验中，5家优秀的脊髓损伤康复中心的治疗师将接受这项技术的培训。加州大学洛杉矶分校协调和数据管理中心将在未来2年内随机分配符合条件的受试者参加常规治疗计划，以提高活动能力，而不是常规治疗加BWSTT的相同强度和持续时间。100名从C4以下至T10/11的不完全性脊髓损伤患者和100名T12至L3病变患者将在脊髓损伤后5周内进入，治疗12周。两个主要结局指标是独立行走水平和行走50英尺的最大速度，分别在治疗12周和随机分组后6个月和12个月进行测试。该结果也将与慢性或完全性脊髓损伤患者相关，在未来，他们可能会接受生物干预与运动训练相结合的治疗。此外，它将证明RCT在发展循证康复实践中的价值和可行性。

After a traumatic spinal cord injury (SCI), recovery of independent ambulation is one of the most important goals for patients during rehabilitation. Most will not recover the ability to walk or will step slowly at a high energy cost that prevents community mobility. No particular rehabilitation strategy has been shown to be better than another at improving locomotor functional independence or maximizing walking speed. We propose the first multicenter, randomized clinical trial (RCT) of a task-oriented locomotor intervention for acute SCI. This strategy applies basic neuroscience research and pilot clinical studies about use-dependent locomotor learning in the lumbosacral neural circuits and supraspinal neurons that coordinate leg movements. The intervention, called body weight-supported treadmill training (BWSTT), partially supports the weight of patients via an overhead lift attached to a harness worn by the subject. Therapists can then systematically train patients to walk on a treadmill at increasingly more functional speeds with less weight support. They correct gait deviations and manipulate sensory inputs that enhance control of the stance and swing phases of walking. For the proposed trial, therapists at 5 outstanding SCI rehabilitation centers will be trained in the technique. The University of California Los Angeles coordinating and data management center will randomly assign eligible subjects over the next 2 years to a conventional therapy program for mobility versus the same intensity and duration of a combination of conventional therapy plus BWSTT. One hundred subjects with incomplete SCI from below C4 to T10/11 and 100 subjects with lesions at T12 to L3 will be entered within 5 weeks of a SCI and treated for 12 weeks. The two primary outcome measures are the level of independence for ambulation and the maximal speed for walking 50 feet, tested after 12 weeks of therapy and 6 and 12 months after randomization. The results will also be relevant to people with chronic or complete SCI who, in the future, may receive biologic interventions combined with locomotor training. In addition, it will demonstrate the value and feasibility of the RCT for developing evidence-based rehabilitation practices.