Skip to main content
OpenTrials
Completed

NCT Number: NCT03300986

Parameter Changes in Functional Electrical Stimulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • • 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

Treatment and study plan

Primary outcomes

  1. Gait analysis will be measured according to routine protocol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2017
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.