<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/NCT04403594</url>
  </required_header>
  <id_info>
    <org_study_id>19-21</org_study_id>
    <nct_id>NCT04403594</nct_id>
  </id_info>
  <brief_title>Functional Intermuscular Reduction of Spasticity</brief_title>
  <acronym>MS-FIRST</acronym>
  <official_title>Functional Intermuscular Reduction of SpasTicity in MS (MS-FIRST)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oklahoma Medical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oklahoma</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>
      Investigators will use muscular dry needling in the calf of one lower extremity, followed by&#xD;
      treadmill training with functional electrical stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be the first to combine a novel two-pronged approach to the management of&#xD;
      spasticity (tightness of the muscle) in the calf muscles. First, investigators will decrease&#xD;
      spasticity in an innovative way through dry needling. Second, investigators will follow this&#xD;
      spasticity reduction technique using external electrical stimulation applied to the calf,&#xD;
      while the participant walks on a harnessed treadmill (for safety). The investigators believe&#xD;
      modulating tone in the calf with dry needling will allow for improved strength with&#xD;
      electrical stimulation, while simultaneously improving the efficiency of the muscles during&#xD;
      walking. The investigators hypothesize that decreasing spasticity will result in enhanced&#xD;
      gait efficiency, and lower fatigue, all while allowing the participant to meet their personal&#xD;
      mobility goals.10 The investigators are proposing an innovative study design. Assessing&#xD;
      changes in muscle spasticity using electromyography and the Modified Ashworth scale before&#xD;
      and after each portion of our two-pronged intervention will enable them to understand the&#xD;
      immediate effects of dry needling, as well as the combined effects of function electrical&#xD;
      stimulation with with treadmill training. Following the intervention assessments with&#xD;
      pre-post functional tests will allow us to determine long term changes. This proposal offers&#xD;
      a unique approach to management of spasticity in people with Multiple Sclerosis (MS), with&#xD;
      the advantage of being minimally invasive and inexpensive. Results of this pilot study will&#xD;
      inform the potential use in MS, and will allow for a larger study examining optimal&#xD;
      intervention parameters for future use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2019</start_date>
  <completion_date type="Actual">April 18, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>6 minute walk test</measure>
    <time_frame>up to 7 weeks</time_frame>
    <description>distance walked over 6 minutes assessed at the start of the study and after 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>25-foot walk</measure>
    <time_frame>up to 7 weeks</time_frame>
    <description>time to walk 25 feet assessed at the start of the study and after 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>up to 7 weeks</time_frame>
    <description>Balance test conducted at the start of the study and after 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Fatigue Impact Scale</measure>
    <time_frame>up to 7 weeks</time_frame>
    <description>patient-reported questionnaire collected at the start of the study and after 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toe taps on force plate</measure>
    <time_frame>up to 7 weeks</time_frame>
    <description>number of toe taps in 10 seconds counted at the start of the study and after 6 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EMG data of both lower extremities</measure>
    <time_frame>up to 7 weeks</time_frame>
    <description>Electromyography (EMG) will be conducted at the start of the study and after 6 weeks. EMG is an electrodiagnostic technique for evaluating and recording the electrical activity produced by skeletal muscles. This is completed using electrodes that are placed on the skin, which detects the electric potential generated by muscle cells when these cells are electrically or neurologically activated. These action potentials are measured and recorded on a computer.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>MS with spasticity of one lower extremity</arm_group_label>
    <description>A person diagnosed with Multiple Sclerosis and spasticty of one lower extremity. The person must be able to walk 25 feet and cannot have had Botox in the lower extremity on the last 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dry needling</intervention_name>
    <description>dry needling followed by functional electrical stimulation and treadmill training</description>
    <arm_group_label>MS with spasticity of one lower extremity</arm_group_label>
    <other_name>functional electrical stimulation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        People with a diagnosis of MS and spasticity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of MS based on MRI&#xD;
&#xD;
          2. Ability walk 25 feet&#xD;
&#xD;
          3. Spasticity of one lower extremity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Blood clot within the last 6 months&#xD;
&#xD;
          2. Bleeding disorder&#xD;
&#xD;
          3. Active cancer&#xD;
&#xD;
          4. Botox in the lower extremities within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shirley James, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oklahoma Medical Research Foundation</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</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>Multiple Sclerosis</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/NCT04403594
org study id: 19-21
nct id: NCT04403594
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators will use muscular dry needling in the calf of one lower extremity, followed by
      treadmill training with functional electrical stimulation.
This study will be the first to combine a novel two-pronged approach to the management of
      spasticity (tightness of the muscle) in the calf muscles. First, investigators will decrease
      spasticity in an innovative way through dry needling. Second, investigators will follow this
      spasticity reduction technique using external electrical stimulation applied to the calf,
      while the participant walks on a harnessed treadmill (for safety). The investigators believe
      modulating tone in the calf with dry needling will allow for improved strength with
      electrical stimulation, while simultaneously improving the efficiency of the muscles during
      walking. The investigators hypothesize that decreasing spasticity will result in enhanced
      gait efficiency, and lower fatigue, all while allowing the participant to meet their personal
      mobility goals.10 The investigators are proposing an innovative study design. Assessing
      changes in muscle spasticity using electromyography and the Modified Ashworth scale before
      and after each portion of our two-pronged intervention will enable them to understand the
      immediate effects of dry needling, as well as the combined effects of function electrical
      stimulation with with treadmill training. Following the intervention assessments with
      pre-post functional tests will allow us to determine long term changes. This proposal offers
      a unique approach to management of spasticity in people with Multiple Sclerosis (MS), with
      the advantage of being minimally invasive and inexpensive. Results of this pilot study will
      inform the potential use in MS, and will allow for a larger study examining optimal
      intervention parameters for future use.
observational model: Case-Control
time perspective: Prospective
measure: 6 minute walk test
time frame: up to 7 weeks
description: distance walked over 6 minutes assessed at the start of the study and after 6 weeks.
measure: 25-foot walk
time frame: up to 7 weeks
description: time to walk 25 feet assessed at the start of the study and after 6 weeks.
measure: Berg Balance Scale
time frame: up to 7 weeks
description: Balance test conducted at the start of the study and after 6 weeks.
measure: Modified Fatigue Impact Scale
time frame: up to 7 weeks
description: patient-reported questionnaire collected at the start of the study and after 6 weeks.
measure: Toe taps on force plate
time frame: up to 7 weeks
description: number of toe taps in 10 seconds counted at the start of the study and after 6 weeks.
measure: EMG data of both lower extremities
time frame: up to 7 weeks
description: Electromyography (EMG) will be conducted at the start of the study and after 6 weeks. EMG is an electrodiagnostic technique for evaluating and recording the electrical activity produced by skeletal muscles. This is completed using electrodes that are placed on the skin, which detects the electric potential generated by muscle cells when these cells are electrically or neurologically activated. These action potentials are measured and recorded on a computer.
arm group label: MS with spasticity of one lower extremity
description: A person diagnosed with Multiple Sclerosis and spasticty of one lower extremity. The person must be able to walk 25 feet and cannot have had Botox in the lower extremity on the last 6 months.
intervention type: Other
intervention name: dry needling
description: dry needling followed by functional electrical stimulation and treadmill training
arm group label: MS with spasticity of one lower extremity
other name: functional electrical stimulation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Shirley James, PhD
role: Principal Investigator
affiliation: University of Oklahoma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
sharing ipd: No