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Parameter Changes in Functional Electrical Stimulation

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ClinicalTrials.gov Identifier: NCT03300986
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Brief Summary:

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.

Condition or disease
Gait Disorders, Neurologic

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Walking Problems

Group/Cohort
Functional Electrical Stimulation (FES) users



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03300986     History of Changes
Other Study ID Numbers: MP16/017
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Nervous System Diseases
Gait Disorders, Neurologic
Neurologic Manifestations
Signs and Symptoms