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临床试验/NCT01320839
NCT01320839已完成不适用

Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task in People With Poststroke Hemiplegia

Nova Scotia Health Authority1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Velocity

研究概览

简要总结

We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will be greater during an attention demanding task.

详细描述

A quasi-experimental, randomized 2 x 2 factorial within subjects study with the factor of walking condition (2 levels, walking with and without ankle-foot orthotic device) and attention condition (2 levels, walking with and without attention task).

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

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

入选标准

  • be over the age of 18;
  • have the presence of hemiplegia after stroke;
  • be wearing an ankle-foot orthosis for at least 6 weeks;
  • be able to walk independently and comfortably for a minimum distance of 12 m with or without assistive aids (AFOs, canes and walkers);
  • be able to read and understand English, follow verbal instructions and provide verbal answers to questions;
  • be able to reach criterion on the attention task (described below)
  • be competent to give informed consent as determined by clinical team and noted in the health chart

排除标准

  • have history of balance deficits not related to stroke;
  • be at high risk of falling during the study;
  • suffer from severe aphasia or dementia as determined by health chart and/or initial cognitive screening using the Montreal Cognitive Assessment (MoCA) test.

结局指标

主要结局

Velocity

时间窗: up to one week

walking velocity

次要结局

  • trunk acceleration(up to one week)
  • Step length variability(up to one week)
  • The Berg Balance Scale(up to one week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kim Parker

Rehabilitation Engineer

Nova Scotia Health Authority

研究点 (1)

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