<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/NCT03834324</url>
  </required_header>
  <id_info>
    <org_study_id>6054</org_study_id>
    <nct_id>NCT03834324</nct_id>
  </id_info>
  <brief_title>Functional Electrical Stimulation During Cycling in People With Spinal Cord Injury</brief_title>
  <acronym>iCycle</acronym>
  <official_title>The Effects of FES Cycling Combined With Virtual Reality Racing on Lower Limb Voluntary Function After Incomplete SCI: A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southampton</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>
      Neuroscience research that has identified potential for recovery (neuroplasticity) following&#xD;
      incomplete SCI has changed clinical practice away from compensation strategies towards&#xD;
      optimizing recovery. Important factors include: repetitive exercise, Functional Electrical&#xD;
      Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES&#xD;
      and provides feedback on performance in a virtual cycle race. Unlike previous devices,&#xD;
      performance in the race is determined only by voluntary effort (i.e. not torque generated by&#xD;
      FES plus voluntary effort). In this study with incomplete SCI participants we will test the&#xD;
      iCycle with six inpatients to refine the protocol and make technical improvements. We will&#xD;
      then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own&#xD;
      homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural&#xD;
      connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as&#xD;
      well qualitative analysis of users' views.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead&#xD;
      to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that&#xD;
      greater neuroplastic effects occur when electrical stimulation of peripheral nerves is&#xD;
      combined with voluntary drive. In this pilot study, we will investigate the effects of a&#xD;
      one-month training programme using a novel device, the iCycle, in which voluntary effort&#xD;
      (cortical drive) is encouraged by virtual reality biofeedback during FES cycling.&#xD;
&#xD;
      Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be&#xD;
      recruited and undergo 12-sessions of iCycle training. Function will be assessed before and&#xD;
      after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford&#xD;
      power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index&#xD;
      for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2013</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 29, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Technology development and Observational study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).</measure>
    <time_frame>Change between baseline and 4 weeks</time_frame>
    <description>Neurological Classification</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).</measure>
    <time_frame>Change between baseline and 8 weeks</time_frame>
    <description>Neurological Classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxford scale motor power grading</measure>
    <time_frame>Change between baseline and 4 weeks</time_frame>
    <description>Muscle strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford scale motor power grading</measure>
    <time_frame>Change between baseline and 8 weeks</time_frame>
    <description>Muscle strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Score (MAS)</measure>
    <time_frame>Change between baseline and 4 weeks</time_frame>
    <description>Spasticity / stiffness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Score (MAS)</measure>
    <time_frame>Change between baseline and 8 weeks</time_frame>
    <description>Spasticity / stiffness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal Cord Independence Measure (SCIM)</measure>
    <time_frame>Change between baseline and 4 weeks</time_frame>
    <description>ADL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal Cord Independence Measure (SCIM)</measure>
    <time_frame>Change between baseline and 8 weeks</time_frame>
    <description>ADL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Index for Spinal Cord Injury (WISCI II)</measure>
    <time_frame>Change between baseline and 4 weeks</time_frame>
    <description>Walking ability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Index for Spinal Cord Injury (WISCI II)</measure>
    <time_frame>Change between baseline and 8 weeks</time_frame>
    <description>Walking ability</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FES</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FES</intervention_name>
    <description>Functional Electrical Stimulation during cycling with Virtual Reality Feedback</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. using a wheelchair for at least two hours per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. cardiac pacemaker&#xD;
&#xD;
          2. pressure sores or unresolved skin problems&#xD;
&#xD;
          3. unhealed lower limb fractures&#xD;
&#xD;
          4. pregnancy&#xD;
&#xD;
          5. active heterotrophic ossification (lower limbs)&#xD;
&#xD;
          6. severe osteoporosis&#xD;
&#xD;
          7. complex regional pain syndrome&#xD;
&#xD;
          8. metal implants near electrode sites&#xD;
&#xD;
          9. lower limb malignancy&#xD;
&#xD;
         10. T6 and below spinal malignancy&#xD;
&#xD;
         11. uncontrolled autonomic dysreflexia&#xD;
&#xD;
         12. history of knee dislocation/subluxation&#xD;
&#xD;
         13. allergy to electrodes&#xD;
&#xD;
         14. cognitive difficulties&#xD;
&#xD;
         15. severe spasticity (Ashworth scale 4 or 5 in muscle groups that would prevent smooth&#xD;
             pedalling) or&#xD;
&#xD;
         16. neurological degenerative diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Trudi Bartlett, BSc</last_name>
    <role>Study Chair</role>
    <affiliation>University of Southampton</affiliation>
  </overall_official>
  <results_reference>
    <citation>Duffell LD, Paddison S, Alahmary AF, Donaldson N, Burridge J. The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. J Neuroeng Rehabil. 2019 Nov 27;16(1):149. doi: 10.1186/s12984-019-0619-4.</citation>
    <PMID>31771600</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southampton</investigator_affiliation>
    <investigator_full_name>Jane Burridge, PhD</investigator_full_name>
    <investigator_title>Professor of Restorative Neuroscience</investigator_title>
  </responsible_party>
  <keyword>Functional Electrical Stimulation</keyword>
  <keyword>Cycling</keyword>
  <keyword>Virtual Reality</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>
    <ipd_description>we have no specific plan for this</ipd_description>
  </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/NCT03834324
org study id: 6054
nct id: NCT03834324
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neuroscience research that has identified potential for recovery (neuroplasticity) following
      incomplete SCI has changed clinical practice away from compensation strategies towards
      optimizing recovery. Important factors include: repetitive exercise, Functional Electrical
      Stimulation (FES) and appropriate feedback. The iCycle combines repetitive exercise with FES
      and provides feedback on performance in a virtual cycle race. Unlike previous devices,
      performance in the race is determined only by voluntary effort (i.e. not torque generated by
      FES plus voluntary effort). In this study with incomplete SCI participants we will test the
      iCycle with six inpatients to refine the protocol and make technical improvements. We will
      then conduct an ABA pilot study (n=10) in which a 3G-connected iCycle is used in people's own
      homes. We will compare usual care (A) with iCycle exercise (B). Changes in neural
      connectivity (TMS evoked EMG potentials), muscle strength and walking will be measured as
      well qualitative analysis of users' views.
Background: Functional Electrical Stimulation (FES) cycling can benefit health and may lead
      to neuroplastic changes following incomplete spinal cord injury (SCI). Our hypothesis is that
      greater neuroplastic effects occur when electrical stimulation of peripheral nerves is
      combined with voluntary drive. In this pilot study, we will investigate the effects of a
      one-month training programme using a novel device, the iCycle, in which voluntary effort
      (cortical drive) is encouraged by virtual reality biofeedback during FES cycling.

      Methods: Eleven participants (C1-T12) with incomplete SCI (5 sub-acute; 6 chronic) will be
      recruited and undergo 12-sessions of iCycle training. Function will be assessed before and
      after training using the bilateral ISNC-SCI motor score neurological (motor) function, Oxford
      power grading, Modified Ashworth Score, Spinal Cord Independence Measure, the Walking Index
      for Spinal Cord Injury and 10m-walk test. Power output will be measured during training.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Technology development and Observational study
primary purpose: Treatment
masking: None (Open Label)
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
time frame: Change between baseline and 4 weeks
description: Neurological Classification
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNC-SCI).
time frame: Change between baseline and 8 weeks
description: Neurological Classification
measure: Oxford scale motor power grading
time frame: Change between baseline and 4 weeks
description: Muscle strength
measure: Oxford scale motor power grading
time frame: Change between baseline and 8 weeks
description: Muscle strength
measure: Modified Ashworth Score (MAS)
time frame: Change between baseline and 4 weeks
description: Spasticity / stiffness
measure: Modified Ashworth Score (MAS)
time frame: Change between baseline and 8 weeks
description: Spasticity / stiffness
measure: Spinal Cord Independence Measure (SCIM)
time frame: Change between baseline and 4 weeks
description: ADL
measure: Spinal Cord Independence Measure (SCIM)
time frame: Change between baseline and 8 weeks
description: ADL
measure: Walking Index for Spinal Cord Injury (WISCI II)
time frame: Change between baseline and 4 weeks
description: Walking ability
measure: Walking Index for Spinal Cord Injury (WISCI II)
time frame: Change between baseline and 8 weeks
description: Walking ability
arm group label: intervention
arm group type: Experimental
description: FES
intervention type: Device
intervention name: FES
description: Functional Electrical Stimulation during cycling with Virtual Reality Feedback
arm group label: intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Trudi Bartlett, BSc
role: Study Chair
affiliation: University of Southampton
citation: Duffell LD, Paddison S, Alahmary AF, Donaldson N, Burridge J. The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. J Neuroeng Rehabil. 2019 Nov 27;16(1):149. doi: 10.1186/s12984-019-0619-4.
PMID: 31771600
responsible party type: Principal Investigator
investigator affiliation: University of Southampton
investigator full name: Jane Burridge, PhD
investigator title: Professor of Restorative Neuroscience
mesh term: Spinal Cord Injuries
sharing ipd: No
ipd description: we have no specific plan for this