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临床试验/NCT01598675
NCT01598675已完成不适用

Error Based Learning for Restoring Gait Symmetry Post-Stroke

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Change from baseline in spatiotemporal gait symmetry after 6 weeks of training

研究概览

简要总结

Many of the 780,000 people affected by stroke each year are left with slow, asymmetric walking patterns. The proposed project will evaluate the effectiveness of two competing motor learning approaches to restore symmetric gait for faster, more efficient, and safer walking.

详细描述

Walking after stroke is characterized by reduced gait speed and the presence of interlimb spatiotemporal asymmetry. These step length and stance time asymmetries can be energy inefficient, challenge balance control, increase the risk of falls and injury, and limit functional mobility. Current rehabilitation to improve gait is based on one of two competing motor learning strategies: minimizing or augmenting symmetry errors during training. Conventional rehabilitation often involves walking on a treadmill while therapists attempt to minimize symmetry errors during training. Although this approach can successfully improve gait speed, it does not produce long-term changes in symmetry. Conversely, augmenting or amplifying symmetry errors has been produced by walking on a split belt treadmill with the belts set at different fixed speeds. While this approach produced an 'after-effect' resulting in step length symmetry for short periods of time, with some evidence of long term learning in people with stroke, it had no influence on stance time asymmetry. The investigators propose that patients need real-time proprioceptive feedback of symmetry errors so that they are actively engaged in the learning process. For this project, the investigators developed and validated a novel, responsive, 'closed loop' control system, using a split-belt instrumented treadmill that continuously adjusts the difference in belt speeds to be proportional to the patient's current asymmetry. Using this system, the investigators can either augment or minimize asymmetry on a step-by-step basis to determine which motor learning strategy produces the largest improvement in overground spatiotemporal symmetry.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ability to walk >10 m overground without physical assistance
  • overground comfortable gait speed (CGS) < 1.0 m/s (using assistive devices and bracing below the knee as needed)
  • able to walk independently on the treadmill at >80% CGS
  • exhibits stance time and/or step length asymmetry during CGS

排除标准

  • cerebellar lesion
  • uncontrolled cardiorespiratory/metabolic disease (cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema)or other neurological or orthopedic disorders that may affect gait training
  • botulinum toxin to the lower limb in the past 6 months
  • a history of balance deficits or unexplained falls not related to the stroke
  • uncontrolled seizures
  • concurrent physical therapy
  • Mini-Mental Status Exam (MMSE) < 24
  • communication impairments which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures

研究组 & 干预措施

Control

Active Comparator

Symmetric Gait. Dual-belted treadmill belts moving at the same belt speeds during training

干预措施: Same Belt Speeds (Other)

Gait Asymmetry

Experimental

Error Augmentation. Belts of a dual-belted treadmill may move at different belt speeds to amplify spatiotemporal gait asymmetry during training

干预措施: Different Belt Speeds (Other)

Gait Symmetry

Experimental

Error Minimization. Belts of a dual-belted treadmill may move at different belt speeds to encourage spatiotemporal gait symmetry during training

干预措施: Different Belt Speeds (Other)

结局指标

主要结局

Change from baseline in spatiotemporal gait symmetry after 6 weeks of training

时间窗: participants will be followed for the duration of their training, expected to be about 6 weeks

Spatiotemporal gait symmetry is calculated as a ratio of paretic to non-paretic measures after walking over a pressure sensitive mat.

次要结局

  • Change from baseline in endurance at 1 month follow up(participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks)
  • Change from baseline in gait speed after 6 weeks of training(participants will be followed for the duration of their training, expected to be about 6 weeks)
  • Change from baseline in metabolic efficiency after 6 weeks of training(participants will be followed for the duration of their training, expected to be about 6 weeks)
  • Change from baseline in gait speed at 1 month follow-up(participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks)
  • Change from baseline in balance at 1 month follow up(participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks)
  • Change from baseline in quality of life at 1 month follow up(participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks)
  • Change from baseline in balance after 6 weeks of training(participants will be followed for the duration of their training, expected to be about 6 weeks)
  • Change from baseline in community ambulation after 6 weeks of training(participants will be followed for the duration of their training, expected to be about 6 weeks)
  • Change from baseline in metabolic efficiency at 1 month follow up(participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks)
  • Change from baseline in spatiotemporal gait asymmetry at 1 month follow up(participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks)
  • Change from baseline in endurance after 6 weeks of training(participants will be followed for the duration of their training, expected to be about 6 weeks)
  • Change from baseline in quality of life after 6 weeks of training(participants will be followed for the duration of their training, expected to be about 6 weeks)
  • Change from baseline in community ambulation at 1 month follow up(participants will be followed for one month following the duration of their training (expected to be about 6 weeks) for a total of 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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