LOCOMOTOR THERAPY TRIAL FOR SPINAL CORD INJURY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 创伤性脊髓损伤（SCI）后，恢复独立自主神经功能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，或者将以高能量成本缓慢行走，从而阻止社区流动。在改善运动功能独立性或最大化步行速度方面，没有一种特定的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）的任务为导向的运动干预急性SCI。该策略应用了基础神经科学研究和关于腰骶神经回路和协调腿部运动的脊髓上神经元中使用依赖性运动学习的试点临床研究。这种干预被称为体重支持跑步机训练（BWSTT），通过连接到受试者佩戴的安全带上的头顶升降机部分支持患者的体重。然后，治疗师可以系统地训练患者在跑步机上以越来越多的功能速度行走，减少重量支撑。他们纠正步态偏差和操纵感官输入，加强控制的立场和摆动阶段的步行。对于拟议的试验，5个优秀的SCI康复中心的治疗师将接受该技术的培训。加州大学洛杉矶分校协调和数据管理中心将在未来2年内随机分配合格受试者接受常规治疗方案，与常规治疗+BWSTT的相同强度和持续时间进行比较。100例C4以下至T10/11的不完全SCI受试者和100例T12至L3病变受试者将在SCI后5周内入组，并接受12周治疗。两个主要的结果指标是独立的amphibia和步行50英尺的最大速度，测试后12周的治疗和6和12个月后随机化。这些结果也将与慢性或完全SCI患者相关，他们在未来可能会接受生物干预与运动训练相结合。此外，它将展示RCT的价值和可行性，为发展循证康复实践。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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.