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.

Study Overview

• Status: Completed
• Conditions: Gait Disorders, Neurologic

• Study Type: Observational
• Enrollment (Anticipated): 10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population for this study is adult users of standard FES for foot drop, registered with the Leeds FES service. Any upper motor neurone lesion can be the primary condition.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Functional Electrical Stimulation (FES) users

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait analysis will be measured according to routine protocol	Gait analysis will measured in accordance with the Plug-In-Gait model guide. This measures 16 points on the subjects left and right leg.	Gait will be assessed over one visit of three hours.

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): May 2, 2017

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: MP16/017