Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI Trial)

背景：在不完全性脊髓损伤（iSCI）的非卧床个体中， 是常见的，并且是限制参与步行活动的主要因素。人们普遍认识到， 需要有效的循证干预措施来增强脊髓损伤后的动态平衡。然而，在这方面， 在iSCI之后改善动态平衡已被证明是非常具有挑战性的。实验性干预措施， 自我产生的运动（例如错误增强）可以通过增强感觉来加速运动学习。 运动反馈和促进替代运动控制策略的探索。这些特征可以 有利于脊髓损伤后再训练动态平衡。我们开发了一种电缆驱动的机器人， 在跑步机行走过程中，通过将连续的粘性力场施加到 骨盆的大小与参与者的实时COM速度成比例。我们的目的是调查 在运动放大环境中进行的运动训练可以有效地改善动态平衡 增加iSCI患者步行活动的参与。 具体目的：目的1：评估在运动放大环境中进行的运动训练是否 有效改善iSCI患者的动态平衡。 我们的试验数据发现，在运动放大环境中进行运动训练后， 三名iSCI患者的动态平衡改善超过30%。这些改善 伴随着更快的地面行走速度和改善的反应平衡。因此，我们假设， 在步行过程中的动态平衡的改善将更大时，运动训练是在一个 与在传统跑步机中进行的运动训练相比， 环境 目的2：评估在运动放大环境中进行运动训练的影响 或者在传统的跑步机环境中参与步行活动。 基于在门诊患者中发现平衡与每日步数之间存在强相关性的证据， 对于iSCI患者，我们假设在运动放大环境中进行训练将积极地 影响动态平衡，进而增加步行活动的参与度。 方法：我们将进行双臂平行分配干预。我们将招募36名门诊参与者 慢性运动不完全性脊髓损伤受试者将被随机分配至对照组 接受运动训练的实验组或接受运动训练的实验组， 放大环境所有参与者将接受20次培训。我们将评估动态变化 使用跨越国际功能、残疾和健康分类（ICF）的衡量标准进行平衡 框架包括：1）步态、平衡和生活质量的临床结局指标，2）生物力学 评估行走过程中控制COM运动的能力，以及3）从活动监测器收集的数据 量化参与步行活动的变化，通过每天走的步数进行评估。 影响：通过放大自身生成的质心，训练iSCI患者的动态平衡 在行走过程中的运动与当前的实践完全不同，并且可能创造有效的新的临床策略 用于解决iSCI患者的平衡障碍。拟议试验的成功结果将 鼓励开发临床可行的工具，首先复制，然后评估运动放大 在VA的临床护理环境中。从这项研究中获得的知识将扩大我们的 了解iSCI患者如何学习动态平衡以及有针对性的动态平衡训练 影响步行活动的参与。

Background: Among ambulatory individuals with incomplete spinal cord injury (iSCI), residual balance deficits are common and are a primary factor limiting participation in walking activities. There is broad recognition that effective evidence-based interventions are needed to enhance dynamic balance following iSCI. However, improving dynamic balance after iSCI has proven to be very challenging. Experimental interventions that amplify self-generated movements (e.g. error augmentation) may accelerate motor learning by intensifying sensory- motor feedback and facilitating exploration of alternative motor control strategies. These features may be beneficial for retraining dynamic balance after iSCI. We have developed a cable-driven robot to create a movement amplification environment during treadmill walking by applying a continuous viscous force field to the pelvis that is proportional in magnitude to a participant’s real-time COM velocity. Our purpose is to investigate if locomotor training performed in a movement amplification environment can effectively improve dynamic balance and increase participation in walking activities of individuals with iSCI. Specific Aims: Aim 1: To evaluate if locomotor training performed in a movement amplification environment is effective for improving dynamic balance of individuals with iSCI. Our pilot data found that following locomotor training performed in a movement amplification environment three individuals with iSCI each improved dynamic balance by more than 30%. These improvements were accompanied by faster over ground walking speeds and improved reactive balance. Thus, we hypothesize that improvements in dynamic balance during walking will be greater when locomotor training is performed in a movement amplification environment when compared to locomotor training performed in a traditional treadmill environment. Aim 2: To evaluate the impact of locomotor training performed in either a movement amplification environment or in a traditional treadmill environment on participation in walking activities. Based on evidence identifying a strong relationship between balance and steps per day in ambulatory individuals with iSCI, we hypothesize that training in the movement amplification environment will positively impact dynamic balance, and in turn increase participating in walking activities. Approach: We will conduct a two-arm parallel-assignment intervention. We will enroll 36 ambulatory participants with chronic motor incomplete spinal cord injury. Participants will be randomized into either a Control group receiving locomotor training or an Experimental group receiving locomotor training performed in a movement amplification environment. All participants will receive 20 training sessions. We will assess changes in dynamic balance using measures that span the International Classification of Functioning, Disability and Health (ICF) framework including; 1) clinical outcome measures of gait, balance, and quality of life, 2) biomechanical assessments of the capacity to control COM motion during walking, and 3) data collected from activity monitors to quantify changes in participation in walking activities as evaluated by number of steps taken per day. Impact: Training dynamic balance of individuals with iSCI by amplifying their own self-generated center of mass motion during walking is a radical departure from current practice and may create effective new clinical strategies for addressing balance impairments of individuals with iSCI. Successful outcomes from the proposed trial would motivate development of clinically-feasible tools to first replicate and then to evaluate the movement amplification environment within the VA’s clinical care settings. Knowledge gained from this study will expand our understanding of how individuals with iSCI learn dynamic balance and how targeted dynamic balance training impacts participation in walking activities.