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临床试验/NCT01095380
NCT01095380已完成2 期

Comparison of Post-SCI Locomotor Training Techniques

University of Miami0 个研究点目标入组 74 人开始时间: 2003年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
74
主要终点
Walking speed

研究概览

简要总结

Background: Body weight supported (BWS) locomotor training improves overground walking ability in individuals with motor-incomplete spinal cord injury (SCI). While there are various approaches available for locomotor training, there is no consensus regarding which of these is optimal. The purpose of this ongoing investigation is to compare outcomes associated with these different training approaches.

Subjects and Methods: Subjects with chronic motor-incomplete SCI have completed training and initial and final testing. Subjects were randomly assigned to 1 of 4 different BWS assisted-stepping groups, including: 1) treadmill training with manual assistance (TM), 2) treadmill training with stimulation (TS), 3) overground training with stimulation (OG), or 4) treadmill training with robotic assistance (LR). Prior to and following participation the investigators assessed:

  • Walking-related outcome measures: overground walking speed, training speed, step length and step symmetry.
  • Spinal cord reflex activity
  • Electromyographic (EMG) associated with walking

Hypotheses:

In individuals with incomplete spinal cord injury (SCI):

  1. A 12-week period of body weight supported treadmill training with TS will produce improvements in walking function that are significantly greater than those produced by training with TM, OG, LR.
  2. TS training will be associated with greater changes to spinal reflex activity than will be observed in subjects trained with manual assistance or non-assisted stepping. Changes to spinal reflex activation will be such that this activity more closely resembles that observed in non-disabled (ND) individuals.
  3. Following participation in this walking regimen, EMG activity observed during walking in all groups will be more robust, more consistent and better coordinated than EMG measures obtained prior to training.

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
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • motor-incomplete spinal cord injury (AIS C or D)
  • at least one year post injury
  • able to step with at at least one leg
  • able to stand from chair with no more than moderate assist of 1 person

排除标准

  • unstable neurologic status
  • active orthopedic problem

结局指标

主要结局

Walking speed

时间窗: 12 weeks

Walking speed collected during 10-Meter Walk Test

次要结局

  • Functional walking capacity(12 weeks)

研究者

申办方类型
Other

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