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临床试验/NCT04473391
NCT04473391Unknown不适用

Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System

Corporación de Rehabilitación Club de Leones Cruz del Sur2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
39
试验地点
2
主要终点
Gait Deviation Index Baseline

研究概览

简要总结

Functional electrical stimulation is a modality of motor rehabilitation that consists of the programmed application of bursts of electrical current to the affected neuromuscular region that aims to improve muscle strength, increase the range of motion, facilitate movement control and decrease spasticity. The present study aimed to measure the changes in the biomechanics of the gait of people with Stroke after training with functional electrical stimulation for the lower extremities.

详细描述

Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.

The present study aimed to identify the changes in the gait characteristics of subjects with stroke after a treatment program with FES for the lower extremities through instrumental gait analysis.

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

  • unilateral lower extremity paresis
  • haemorrhagic or ischemic stroke
  • a minimum of six months after the acute infarction/onset of the disease
  • full passive range of motion in lower extremity or at least at neutral position
  • be able to stand freely
  • be able to walk with or without aid for at least 20 meters in less than 2 minutes

排除标准

  • peripheral nervous system pathology
  • weight over 100 kg
  • no cognitive ability to follow the study instructions
  • pregnancy
  • use of implanted devices
  • instable lower extremity joints or fixed contracture

结局指标

主要结局

Gait Deviation Index Baseline

时间窗: Baseline

Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

Gait Deviation Index Post-Intervention

时间窗: 12 weeks

Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

次要结局

  • Gait Speed Baseline(Baseline)
  • Gait Speed Post-intervention(12 weeks)

研究者

发起方
Corporación de Rehabilitación Club de Leones Cruz del Sur
申办方类型
Other
责任方
Sponsor

研究点 (2)

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