跳至主要内容
临床试验/NCT00125619
NCT00125619已完成不适用

Internally v. Externally Guided BWSTT for Locomotor Recovery Post-stroke

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2005年9月1日最近更新:
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
16
试验地点
1
主要终点
Self-selected Overground Walking Speed

研究概览

简要总结

The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis.

详细描述

In this pilot study, we tested two forms of locomotor training for gait rehabilitation in persons post-stroke: traditional locomotor training (partial body-weight support and manual assistance of therapists) vs. robotic-assisted locomotor training (partial body-weight support and robotic guidance with the Lokomat). We enrolled 16 persons with chronic (>6 months) hemiparesis post-stroke who were randomized to traditional/manual or robotic locomotor training. All individuals received 12 sessions (thrice weekly for four weeks) of training. Each session involved 30 minutes of stepping.

The complete study results are published.

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
None

入排标准

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

入选标准

  • •Clinical diagnosis of cerebrovascular accident
  • •Single event
  • •Unilateral hemiplegia
  • •Locomotor disability
  • •Ability to walk independently 25' on level ground (may use an assistive device [cane or walker]; may NOT use a brace)
  • •Cognitive ability to follow 3-step commands

排除标准

  • •Unstable or uncontrolled blood pressure
  • •Uncontrolled seizures
  • •Severe cognitive impairment

研究组 & 干预措施

Arm 2: Robot-assisted

Experimental

Robot-assisted locomotor training (partial body-weight supported)

干预措施: Locomotor training (Behavioral)

Arm 1: Therapist assisted

Active Comparator

Therapist assisted locomotor training (partial body-weight supported)

干预措施: Locomotor training (Behavioral)

结局指标

主要结局

Self-selected Overground Walking Speed

时间窗: 4 weeks (s/p 12 sessions of locomotor training)

Overground walking speed determined as rate of walking over a 10 meter distance.

次要结局

  • Six Minute Walk(4 weeks)
  • Fast Walking Speed(4 weeks (s/p 12 training sessions))
  • Step Length Ratio (Abs)(4 weeks)
  • Berg Balance Scale(4 weeks)
  • Lower Extremity Fugl-Meyer Motor Assessment(4 weeks)
  • Short Physical Performance Battery(4 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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