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

增强步态以改善脊髓损伤的运动参与（AGILE SCI 试验）

• 批准号: 10382289
• 负责人: Keith Edward Gordon
• 金额: --
• 依托单位: EDWARD HINES JR VA HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10382289
• 关键词: Address; Affect; Balance training; Bone Density; Caring; Chronic; Classification; Clinic; Clinical; Control Groups; Data; Detection; Development; Diabetes Mellitus; Educational Intervention; Enrollment; Environment; Equilibrium; Evidence based intervention; Feedback; Financial Hardship; Gait; Health; Home; Impairment; Individual; Injury; International; Intervention; Knowledge; Laboratories; Learning; Locomotor training; Measures; Mental Depression; Modeling; Monitor; Motion; Motor; Movement; Nervous system structure; Neuromechanics; Occupational; Outcome; Participant; Pelvis; Periodicity; Population; Quality of life; Randomized; Rehabilitation therapy; Research; Residual state; Robot; Sensory; Spinal cord injury; Testing; Time; Training; Training Programs; Update; Veterans; Walking; Work; arm; base; biomechanical test; cardiovascular health; clinical care; clinical development; clinical outcome measures; community setting; cost; design; disability; equilibration disorder; experimental group; improved; improved mobility; motor control; motor impairment; motor learning; novel strategies; response; sedentary; social; tool; treadmill; walking speed

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.

背景：在不完全脊髓损伤(ISCI)的非卧床患者中，残存平衡缺陷 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 需要采取有效的循证干预措施，以增强ISCI后的动态平衡。然而， 在ISCI后改善动态平衡已被证明是非常具有挑战性的。放大的实验性干预 自我产生的动作(例如错误增强)可能会通过强化感觉来加速运动学习。 电机反馈和促进探索替代的电机控制策略。这些功能可能是 有利于ISCI后再训练动态平衡。我们已经开发了一种缆绳驱动的机器人来创造一个 在跑步机上行走时施加连续粘性力场的运动放大环境 骨盆的大小与参与者的实时COM速度成正比。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度。 具体目标：目标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。 我们的飞行员数据发现，以下运动训练是在运动放大环境中进行的 三个患有ISCI的人各自改善了30%以上的动态平衡。这些改进是 伴随着更快的地面行走速度和更好的反应性平衡。因此，我们假设 在步行过程中进行运动训练时，动态平衡的改善会更大 与在传统跑步机上进行的运动训练相比，运动放大环境 环境。 目的2：评估在两种运动放大环境中进行的运动训练的影响 或在传统的跑步机环境中参与步行活动。 基于确定平衡性与门诊每日步数之间密切关系的证据 有ISCI的个体，我们假设在运动放大环境中的训练将是积极的 影响动态平衡，进而增加步行活动的参与度。 研究方法：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 伴有慢性运动不完全性脊髓损伤。参与者将被随机分成对照组 接受运动训练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果测量；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 通过每天步行的步数来量化参与步行活动的变化。 影响：通过放大自身产生的重心来训练ISCI患者的动态平衡 步行时的运动与目前的做法有很大的不同，可能会创造出有效的新临床策略。 用于解决ISCI患者的平衡障碍。拟议试验的成功结果将是 推动临床可行工具的开发，首先复制，然后评估运动放大 退伍军人事务部的临床护理环境。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如何有针对性地进行动态平衡训练 影响步行活动的参与度。