Variable Intensive Early Walking post-Stroke (VIEWS)

中风后早期可变强化步行 (VIEWS)

• 批准号: 10586826
• 负责人: Thomas George Hornby
• 金额: $ 50.16万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586826
• 关键词: Address; Adherence; Adverse event; Attention; Blinded; Cardiopulmonary; Cardiovascular system; Chronic; Clinical Trials Design; Communities; Data; Educational Intervention; Equilibrium; Event; Exercise; Face; Gait; Gait speed; Goals; Health; Health Services; Human Resources; Impairment; Incidence; Individual; Inferior; Injury; Intervention; Joints; Laboratories; Locomotor Recovery; Measures; Metabolic; Movement; Multicenter Studies; Nervous System Trauma; Neuronal Plasticity; Outcome; Participant; Patients; Pattern; Persons; Phase; Phase II Clinical Trials; Productivity; Quality of life; Recovery; Rehabilitation therapy; Research; Risk; Specificity; Speed; Step training; Stroke; Testing; Training; Walking; Work; adverse event risk; cardiovascular risk factor; chronic stroke; clinical implementation; clinical practice; clinical translation; comparative efficacy; conventional therapy; cost; cost effectiveness; exercise intensity; exercise intervention; exercise training; fitness; follow-up; gait symmetry; improved; improved mobility; innovation; kinematics; neurological recovery; post stroke; primary outcome; randomized, clinical trials; robotic device; spatiotemporal; theories; treadmill

Project Summary The objective of this Phase II clinical trial is to identify how exercise training parameters, particularly the specificity and intensity of stepping practice, influence long-term mobility outcomes in patients with subacute stroke. Previous work indicates these variables can influence the efficacy of training interventions in individuals without neurological injury, with some data to support their utility in chronic stroke. However, studies that systematically assess the independent and combined effects of these principles in individuals early following stroke are sparse. This critical research gap impedes clinical translation, and current clinical practices remain adherent to traditional theories of rehabilitation, including lower intensity interventions focused on underlying impairments. Additional concerns of providing only high-intensity walking training revolve around the lack of attention toward movement quality will result in use of compensatory movement strategies that could be reinforced with repeated practice, or that other risks of cardiovascular events should preclude high- intensity training. Unfortunately, there is little data to support these hypotheses, and our studies suggest that application of these training parameters can strongly influence walking function, as well as improve underlying impairments and improve gait kinematics. Our approach is to characterize the effects of these training variables on recovery of locomotor function and quality, as well as changes in impairments and other mobility tasks in patients early post-stroke, in an effort to evaluate whether such training influences neurological recovery or whether patients utilize compensatory strategies. In this 2x2 factorial RCT design, Aim 1 of the study will characterize changes in mobility function associated with manipulation of specific and intensity of exercise interventions. We will evaluate functional measures of gait speed and endurance, spatiotemporal symmetry, as well as measures of cardiopulmonary fitness. We postulate that combined application of high- intensity, task specific stepping practice will result in significantly greater increases in locomotor measures as compared to lower intensity or non-specific training paradigms. In Aim 2, we will characterize the changes in impairments (strength) and other mobility tasks (balance, sit-to-stand transfers) to determine whether stepping intervention can mitigate the major impairments underlying post-stroke impairments. Quantitative measures of volitional strength will be the primary outcomes. In Aim 3, we will characterize changes in community mobility and quality of life, the later of which can inform us about cost-effectiveness. Overall, these results have potential implications on the delivery of effective exercise interventions in person with subacute stroke.

项目概要 这项 II 期临床试验的目的是确定运动训练参数，特别是运动训练参数如何 踏步练习的特异性和强度，影响亚急性患者的长期活动结果 中风。先前的研究表明这些变量可以影响培训干预的效果 没有神经损伤的个体，有一些数据支持其在慢性中风中的效用。然而， 系统评估这些原则对个体早期的独立和综合影响的研究 后续中风稀疏。这一关键的研究差距阻碍了临床转化，而当前的临床 实践仍然遵循传统的康复理论，包括重点关注的较低强度干预措施 关于潜在的损害。仅提供高强度步行训练的其他问题围绕 缺乏对运动质量的关注将导致使用补偿性运动策略 可以通过反复练习来加强，或者心血管事件的其他风险应该排除高风险 强度训练。不幸的是，几乎没有数据支持这些假设，我们的研究表明 这些训练参数的应用可以强烈影响步行功能，并改善基础能力 损伤并改善步态运动学。我们的方法是描述这些培训的效果 运动功能和质量恢复的变量，以及损伤和其他活动能力的变化 中风后早期患者的任务，以评估这种训练是否影响神经功能 康复或患者是否采用补偿策略。在此 2x2 阶乘 RCT 设计中，目标 1 研究将描述与特定的和强度的操作相关的活动功能的变化。 运动干预。我们将评估步态速度和耐力、时空的功能测量 对称性以及心肺健康的测量。我们假设高的组合应用 强度、特定任务的步进练习将导致运动测量的显着增加，因为 与较低强度或非特定的训练模式相比。在目标 2 中，我们将描述以下方面的变化： 损伤（力量）和其他移动任务（平衡、从坐到站的转换）以确定是否可以迈步 干预可以减轻中风后损伤的主要损伤。定量测量 意志力将是主要结果。在目标 3 中，我们将描述社区流动性的变化 和生活质量，后者可以告诉我们成本效益。总体而言，这些结果 对亚急性中风患者实施有效运动干预的潜在影响。