<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/NCT03254862</url>
  </required_header>
  <id_info>
    <org_study_id>GN17NE114</org_study_id>
    <nct_id>NCT03254862</nct_id>
  </id_info>
  <brief_title>Different Stimulation Patterns to Reduce Muscle Fatigue During FES</brief_title>
  <official_title>Investigation of Different Stimulation Patterns to Reduce Muscle Fatigue During Functional Electrical Stimulation (FES)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of this study is to investigate the effect of patterned distribution stimulation&#xD;
      compared to conventional stimulation in reducing muscle fatigue during functional electrical&#xD;
      stimulation (FES) following spinal cord injury (SCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional electrical stimulation (FES) is a commonly used technique in rehabilitation and&#xD;
      often associated with rapid muscle fatigue which becomes the limiting factor in its&#xD;
      applications. The main objective of this study is to investigate the effects on the onset of&#xD;
      fatigue of conventional synchronous stimulation, as well as asynchronous stimulation that&#xD;
      mimic voluntary muscle activation targeting different motor units which are activated&#xD;
      sequentially or randomly via multiple pairs of stimulation electrodes. Three different&#xD;
      approaches with various electrode configurations will be investigated, as well as different&#xD;
      patterns of stimulation applied to the gastrocnemius muscle. In addition, the muscle changes&#xD;
      during different patterns of stimulation will be evaluated in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Initial difficulties recruiting + main researcher had to withdraw from the study&#xD;
  </why_stopped>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle contraction ability</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Change in torque produced during muscle contraction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Normalized Fatigue Index (NFI)</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Change in score on Normalized Fatigue Index (NFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Time Interval (FTI)</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Change in Fatigue Time Interval (FTI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Twitch-Tetanus Ratio response (ΔTTR)</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>Change in Twitch-Tetanus Ratio response (ΔTTR)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Group A: CSS &amp; AsynS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrical stimulation training on both legs:&#xD;
Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: CSS &amp; AsynR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrical stimulation training on both legs:&#xD;
Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CSS/AsynS</intervention_name>
    <description>16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Sequential Stimulation (ASynS) on the other leg</description>
    <arm_group_label>Group A: CSS &amp; AsynS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CSS/AsynR</intervention_name>
    <description>16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Random Stimulation (ASynR) on the other leg.</description>
    <arm_group_label>Group B: CSS &amp; AsynR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  incomplete spinal cord injury&#xD;
&#xD;
          -  able to give informed consent&#xD;
&#xD;
          -  able to sit up in a chair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  female subjects who are pregnant&#xD;
&#xD;
          -  significant history of autonomic dysreflexia&#xD;
&#xD;
          -  unable to give informed consent&#xD;
&#xD;
          -  individuals who have a cardiac history&#xD;
&#xD;
          -  individuals who have significant cognitive impairment&#xD;
&#xD;
          -  individuals with muscular abnormality&#xD;
&#xD;
          -  individuals who have significant contractures in the lower extremities&#xD;
&#xD;
          -  individuals who have a rash or infection at the site of electrode placement&#xD;
             (gastrocnemius for both legs)&#xD;
&#xD;
          -  individuals who are hypersensitive to electrical stimulation&#xD;
&#xD;
          -  individuals who are presently involved in another study which has overlap with the&#xD;
             methodology and/or outcomes of the studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henrik Gollee, DipIng PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Glasgow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth National Spinal Injuries Unit</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 5, 2018</last_update_submitted>
  <last_update_submitted_qc>September 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Functional electrical stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03254862
org study id: GN17NE114
nct id: NCT03254862
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of this study is to investigate the effect of patterned distribution stimulation
      compared to conventional stimulation in reducing muscle fatigue during functional electrical
      stimulation (FES) following spinal cord injury (SCI).
Functional electrical stimulation (FES) is a commonly used technique in rehabilitation and
      often associated with rapid muscle fatigue which becomes the limiting factor in its
      applications. The main objective of this study is to investigate the effects on the onset of
      fatigue of conventional synchronous stimulation, as well as asynchronous stimulation that
      mimic voluntary muscle activation targeting different motor units which are activated
      sequentially or randomly via multiple pairs of stimulation electrodes. Three different
      approaches with various electrode configurations will be investigated, as well as different
      patterns of stimulation applied to the gastrocnemius muscle. In addition, the muscle changes
      during different patterns of stimulation will be evaluated in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Muscle contraction ability
time frame: Baseline to 6 weeks
description: Change in torque produced during muscle contraction
measure: Normalized Fatigue Index (NFI)
time frame: Baseline to 6 weeks
description: Change in score on Normalized Fatigue Index (NFI)
measure: Fatigue Time Interval (FTI)
time frame: Baseline to 6 weeks
description: Change in Fatigue Time Interval (FTI)
measure: Twitch-Tetanus Ratio response (ΔTTR)
time frame: Baseline to 6 weeks
description: Change in Twitch-Tetanus Ratio response (ΔTTR)
arm group label: Group A: CSS & AsynS
arm group type: Experimental
description: Electrical stimulation training on both legs:
Conventional synchronous stimulation (CSS) and Asynchronous Sequential Stimulation (ASynS) - CSS/ASynS
arm group label: Group B: CSS & AsynR
arm group type: Experimental
description: Electrical stimulation training on both legs:
Conventional synchronous stimulation (CSS) and Asynchronous Random Stimulation (ASynR) - CSS/ASynR
intervention type: Procedure
intervention name: CSS/AsynS
description: 16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Sequential Stimulation (ASynS) on the other leg
arm group label: Group A: CSS & AsynS
intervention type: Procedure
intervention name: CSS/AsynR
description: 16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Random Stimulation (ASynR) on the other leg.
arm group label: Group B: CSS & AsynR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Henrik Gollee, DipIng PhD
role: Study Director
affiliation: University of Glasgow
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
sharing ipd: No