<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03300986</url>
  </required_header>
  <id_info>
    <org_study_id>MP16/017</org_study_id>
    <nct_id>NCT03300986</nct_id>
  </id_info>
  <brief_title>Parameter Changes in Functional Electrical Stimulation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Leeds Teaching Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to look at how changes to a person's functional electrical stimulation might&#xD;
      change how they walk. Functional electrical stimulation (FES) is commonly used to help people&#xD;
      with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. This&#xD;
      group of people have muscle weakness which makes it difficult to lift the foot, which causes&#xD;
      trips and falls.&#xD;
&#xD;
      FES reduces foot drop by using a portable device to apply short electrical pulses to the&#xD;
      nerve which lifts the foot. The FES device stimulates this nerve only during the swing phase,&#xD;
      when the foot is off the floor. Typically this is achieved by using a foot-switch, which&#xD;
      detects when the heel leaves the floor. Stimulation begins a short interval of time after the&#xD;
      heel leaves the floor, ramps up from zero to set stimulation for the individual, and at&#xD;
      another period of time after the heel hits the floor, stimulation ramps down from set amount&#xD;
      to zero. There are four time intervals described here which can be varied by the clinician on&#xD;
      the device:-&#xD;
&#xD;
        -  Delay (the time between heel lift and the start of stimulation)&#xD;
&#xD;
        -  Ramp up (the time for stimulation to reach full strength)&#xD;
&#xD;
        -  Extension (the time between heel strike and the ramp down)&#xD;
&#xD;
        -  Ramp down (the time for stimulation to reach zero from full strength) These intervals&#xD;
           are usually set by experienced clinicians using a qualitative assessment of the&#xD;
           patient's walking and trial-and-error. A literature review has found no published&#xD;
           studies which compare walking with different timing. This knowledge would be useful for&#xD;
           clinicians, who could use this information as a starting point in finding the best&#xD;
           timing parameters for each patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">May 2, 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gait analysis will be measured according to routine protocol</measure>
    <time_frame>Gait will be assessed over one visit of three hours.</time_frame>
    <description>Gait analysis will measured in accordance with the Plug-In-Gait model guide. This measures 16 points on the subjects left and right leg.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Gait Disorders, Neurologic</condition>
  <arm_group>
    <arm_group_label>Functional Electrical Stimulation (FES) users</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The population for this study is adult users of standard FES for foot drop, registered with&#xD;
        the Leeds FES service. Any upper motor neurone lesion can be the primary condition.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Upper motor neurone lesion causing foot drop&#xD;
&#xD;
          -  Currently use single-channel Odstock Medical ODFS functional electrical stimulator&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Attending Leeds FES Service follow-up clinics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • FES user for less than three months&#xD;
&#xD;
               -  Lower limb prosthesis&#xD;
&#xD;
               -  Cannot walk 5m with walking aids&#xD;
&#xD;
               -  Cannot walk twenty 5m walks within a three-hour period&#xD;
&#xD;
               -  Use FES less than once per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03300986
org study id: MP16/017
nct id: NCT03300986
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: Gait analysis will be measured according to routine protocol
time frame: Gait will be assessed over one visit of three hours.
description: Gait analysis will measured in accordance with the Plug-In-Gait model guide. This measures 16 points on the subjects left and right leg.
arm group label: Functional Electrical Stimulation (FES) users
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic