跳至主要内容
临床试验/NCT03300986
NCT03300986已完成不适用

Parameter Changes in Functional Electrical Stimulation

The Leeds Teaching Hospitals NHS Trust0 个研究点目标入组 10 人开始时间: 2016年4月1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
10
主要终点
Gait analysis will be measured according to routine protocol

研究概览

简要总结

This study aims to look at how changes to a person's functional electrical stimulation might change how they walk. Functional electrical stimulation (FES) is commonly used to help people with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. This group of people have muscle weakness which makes it difficult to lift the foot, which causes trips and falls.

FES reduces foot drop by using a portable device to apply short electrical pulses to the nerve which lifts the foot. The FES device stimulates this nerve only during the swing phase, when the foot is off the floor. Typically this is achieved by using a foot-switch, which detects when the heel leaves the floor. Stimulation begins a short interval of time after the heel leaves the floor, ramps up from zero to set stimulation for the individual, and at another period of time after the heel hits the floor, stimulation ramps down from set amount to zero. There are four time intervals described here which can be varied by the clinician on the device:-

  • Delay (the time between heel lift and the start of stimulation)
  • Ramp up (the time for stimulation to reach full strength)
  • Extension (the time between heel strike and the ramp down)
  • Ramp down (the time for stimulation to reach zero from full strength) These intervals are usually set by experienced clinicians using a qualitative assessment of the patient's walking and trial-and-error. A literature review has found no published studies which compare walking with different timing. This knowledge would be useful for clinicians, who could use this information as a starting point in finding the best timing parameters for each patient.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Upper motor neurone lesion causing foot drop
  • •Currently use single-channel Odstock Medical ODFS functional electrical stimulator
  • •Age 18 or older
  • •Attending Leeds FES Service follow-up clinics

排除标准

  • •• FES user for less than three months
  • •Lower limb prosthesis
  • •Cannot walk 5m with walking aids
  • •Cannot walk twenty 5m walks within a three-hour period
  • •Use FES less than once per week

结局指标

主要结局

Gait analysis will be measured according to routine protocol

时间窗: Gait will be assessed over one visit of three hours.

Gait analysis will measured in accordance with the Plug-In-Gait model guide. This measures 16 points on the subjects left and right leg.

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

相似试验

Parameter Changes in Functional Electrical... | 临床试验