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临床试验/NCT04266899
NCT04266899已完成不适用

The Effect of Neuro-orthosis on Gait Performer in Chronic Post Stroke Subjects

Federal University of Health Science of Porto Alegre1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Assessment of gait speed

研究概览

简要总结

The aim of this study is to verify the effectiveness of foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild, moderate and severe compromise.

详细描述

The stroke subjects are going to perform the walking training with Foot drop stimulator on the treadmill. All the evaluations will be performed with a foot drop stimulator turned off and on. One month later, that finished the intensive treatment; the participants were also evaluated only without the stimulation of FDS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with ischemic or hemorrhagic stroke diagnosis.
  • Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
  • Minimal cognitive ability to understand commands
  • Able to walk 10 meters unassisted or with minimal assistance

排除标准

  • Secondary musculoskeletal disorder involving the lower limb
  • Contraindication for electrical stimulation

结局指标

主要结局

Assessment of gait speed

时间窗: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)

Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400)

次要结局

  • Assessment of cadence by means number of steps by the minute.(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Changes in center of pressure displacement(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Assessment of Stride length and Step length of gait(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Assessment of angular kinematics of hip, knee and ankle(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Muscular tone assessed by the Modified Ashworth Scale(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Assessment of Gait speed in external environment(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Postural Control(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Functional Mobility(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Assessment of duration of stance and swing phase of gait(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))
  • Assessment of Harmonic Ration of Gait(Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up))

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aline de Souza Pagnussat

Principal Investigator

Federal University of Health Science of Porto Alegre

研究点 (1)

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