xml: <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/NCT05964829</url>
    </required_header>
    <id_info>
      <org_study_id>CIONIC-06-001</org_study_id>
      <nct_id>NCT05964829</nct_id>
    </id_info>
    <brief_title>Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis</brief_title>
    <official_title>A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cionic, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cionic, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for&#xD;
        individuals diagnosed with multiple sclerosis (MS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The randomized within-participants crossover study aims to demonstrate the clinical impact of&#xD;
        the Cionic Neural Sleeve for individuals diagnosed with MS.&#xD;
  &#xD;
        Physical measurements, performance-based tests, and questionnaire responses will be recorded.&#xD;
        These include physical activity recorded by an Actigraph; in-person tests measuring&#xD;
        disability, spasticity and balance; and questionnaires gauging perceived walking ability,&#xD;
        quality of life, and physical and psychological impact of MS.&#xD;
  &#xD;
        All participants will be assigned a hip-worn Actigraph activity monitor, a Cionic Neural&#xD;
        Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of&#xD;
        walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the&#xD;
        12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the&#xD;
        study.&#xD;
  &#xD;
        Participants will be randomized to one of two groups: A or B. Group A will wear the Actigraph&#xD;
        and receive stimulation assisted walking from the Neural Sleeve (intervention), while group B&#xD;
        will only wear the Actigraph while walking. After 6 weeks, participants in each group will&#xD;
        cross over to the other group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Gait Speed</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>The Timed 25-Foot Walk Test (T25FWT) to record duration of time to walk a distance of 25 feet, measured in seconds. The score is the average of two successive trials.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Perceived Walking Ability</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Multiple Sclerosis Walking Scale-12 (MSWS-12) to measure perceived impact of MS on walking ability, measured by score. Scores on the MSWS-12 range from 12-60 and transformed to a scale with a range from 0 to 100, with high scores indicative of a greater impact of MS on walking.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in MS Disability</measure>
      <time_frame>Day 0, Week 6, Week 12</time_frame>
      <description>Expanded Disability Status Scale (EDSS), administered by a trained clinician, to quantify disability in MS and monitor changes in the level of disability over time. The EDSS scale ranges from 0 to 10, with high scores indicative of higher levels of disability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Fall Risk</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Berg Balance Scale (BBS) to assess balance in 14 tasks, measured by score. Scores of the BBS range from 0 to 56, with 0-20 being wheelchair bound, 21-40 being walking with assistance, and 41-56 classified as independent.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Amount of Daily Walking/Activity Level</measure>
      <time_frame>Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16</time_frame>
      <description>Collected by the usage log of the device(s), measured in steps per day</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of Daily Walking/Activity Level</measure>
      <time_frame>Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16</time_frame>
      <description>Collected by the usage log of the device(s), measured in duration of activity.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Change in Health-Related Quality of Life</measure>
      <time_frame>Day 0, Week 6, Week 12</time_frame>
      <description>The Euroqol 5 Dimension 5 Level (EQ-5D-5L) questionnaire describes health profiles using different domains, measured by a 5-digit code. Single-digit numbers of the dimensions range from 1 to 5, with 1 indicative of no problem and 5 indicative of extreme problems in that domain.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Impact of MS</measure>
      <time_frame>Day 0, Week 6, Week 12</time_frame>
      <description>Multiple Sclerosis Impact Scale-29 (MSIS-29) questionnaire to measure the physical and psychological impact of MS, measured by score. Scores on the MSIS-29 are transformed into a score out of 100, with higher scores indicative of greater degree of disability.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Perceived Fatigue</measure>
      <time_frame>Day 0, Week 6, Week 12</time_frame>
      <description>Modified Fatigue Impact Scale (MFIS) survey to measure the effects of fatigue in physical, cognitive, and psychosocial functioning. MFIS score ranges from 0 to 84, with high scores indicative of a greater impact of fatigue on activities.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Spasticity</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>A trained clinician will administer the Modified Ashworth Scale (MAS) to assess for muscle tone and spasticity. Scores of the MAS range from 0 to 4, with high scores representative of increased muscle tone and spasticity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Lower Limb Strength</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Ankle Plantarflexor Strength</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Lower Limb Range of Motion</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Walking Endurance</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Balance</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Measured using force platform posturography in standing to quantify postural sway. There will be four 30-second trials with eyes open standing as still as possible.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Blood Lipids</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Measured utilizing point of care analysis. The Cholestech LDX Analyzer provides accurate, actionable, and readily accessible results for point-of-care lipid profile and cholesterol testing, measured in milligrams per deciliter. Rapid, accurate results provide immediate awareness and identification of cardiovascular and diabetes health risks in only 5 minutes.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Blood Glucose</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Measured utilizing point of care analysis. The Cholestech LDX Analyzer provides accurate, actionable, and readily accessible results for point-of-care glucose testing, measured in milligrams per deciliter. Rapid, accurate results provide immediate awareness and identification of cardiovascular and diabetes health risks in only 5 minutes.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Incidence of Falls</measure>
      <time_frame>From enrollment to end of treatment at 12 weeks, post-intervention at Week 16</time_frame>
      <description>Measured using a self-reported fall diary and a survey, the Hopkins Fall Grading Scale, a 4-point scale to grade the nature and severity of a fall. Higher grades represent increased severity and impact of injurious falls.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Medication(s) and Dosage</measure>
      <time_frame>Day 0, Week 1, Week 6, Week 12, post-intervention at Week 16</time_frame>
      <description>Measured by changes in dose intensities of prescribed medication(s).</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Pain</measure>
      <time_frame>Week 1, Week 6, Week 12</time_frame>
      <description>Measured using the questionnaire, the Numeric Pain Rating Scale (NPRS), an 11-point numeric scale ranging from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Self-Reported Physical Activity</measure>
      <time_frame>From enrollment to end of treatment at 12 weeks, post-intervention at Week 16</time_frame>
      <description>Subjects will record their weekly physical activity using the Godin-Leisure Time Exercise Questionnaire (GLTEQ), measured by score. Scores less than 14 units are interpreted as insufficiently active/sedentary, while scores between 14 and 23 are interpreted as moderately active, and scores greater than 24 units are interpreted as active.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Multiple Sclerosis, Relapsing-Remitting</condition>
    <condition>Multiple Sclerosis, Chronic Progressive</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will follow the walking program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Functional electrical stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will follow the walking program and receive stimulation assistance during the walking sessions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cionic Neural Sleeve NS-100</intervention_name>
      <description>The Cionic Neural Sleeve applies functional electrical stimulation as subjects walk to help contract appropriate muscles at appropriate times. The Cionic Neural Sleeve will be worn for 6 weeks.</description>
      <arm_group_label>Functional electrical stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Actigraph accelerometer</intervention_name>
      <description>Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Functional electrical stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and&#xD;
               75&#xD;
  &#xD;
            -  Ability to ambulate at least 15 minutes throughout the day for five days per week,&#xD;
               with or without assistive device&#xD;
  &#xD;
            -  Adequate cognitive and communicative function as assessed via Telephone Interview for&#xD;
               Cognitive Status (TICS) to identify persons with dementia&#xD;
  &#xD;
            -  Able to tolerate the Neural Sleeve device for up to 8 hours per day&#xD;
  &#xD;
            -  T25FWT time between 8 and 45 seconds&#xD;
  &#xD;
            -  No recent change in medication or recent exacerbation of symptoms over the last 60&#xD;
               days&#xD;
  &#xD;
            -  Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair&#xD;
               response to stimulation&#xD;
  &#xD;
            -  Absent sensation in the impacted or more impacted leg&#xD;
  &#xD;
            -  Inadequate response to stimulation, defined by inability to achieve muscle contraction&#xD;
               or unable to tolerate stimulation&#xD;
  &#xD;
            -  Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee&#xD;
               ankle foot orthosis (KAFO) if utilized&#xD;
  &#xD;
            -  History of falls greater than once a week&#xD;
  &#xD;
            -  No use of FES devices in the past year&#xD;
  &#xD;
            -  Demand-type cardiac pacemaker or defibrillator&#xD;
  &#xD;
            -  Malignant tumor in the impacted or more impacted leg&#xD;
  &#xD;
            -  Existing thrombosis in the impacted or more impacted leg&#xD;
  &#xD;
            -  Fracture or dislocation in the impacted or more impacted leg that could be adversely&#xD;
               affected by motion from stimulation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Douglas A Wajda, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cleveland State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Douglas A Wajda, PhD</last_name>
      <phone>3308837149</phone>
      <email>d.a.wajda@csuohio.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rebecca Webster, PhD</last_name>
      <phone>925-788-6649</phone>
      <email>rebecca@cionic.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cleveland State University</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Douglas A Wajda</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>
      <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
      <mesh_term>Multiple Sclerosis, Chronic Progressive</mesh_term>
      <mesh_term>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>
  
  
text: 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/NCT05964829
  org study id: CIONIC-06-001
  nct id: NCT05964829
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for
        individuals diagnosed with multiple sclerosis (MS).
  The randomized within-participants crossover study aims to demonstrate the clinical impact of
        the Cionic Neural Sleeve for individuals diagnosed with MS.
  
        Physical measurements, performance-based tests, and questionnaire responses will be recorded.
        These include physical activity recorded by an Actigraph; in-person tests measuring
        disability, spasticity and balance; and questionnaires gauging perceived walking ability,
        quality of life, and physical and psychological impact of MS.
  
        All participants will be assigned a hip-worn Actigraph activity monitor, a Cionic Neural
        Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of
        walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the
        12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the
        study.
  
        Participants will be randomized to one of two groups: A or B. Group A will wear the Actigraph
        and receive stimulation assisted walking from the Neural Sleeve (intervention), while group B
        will only wear the Actigraph while walking. After 6 weeks, participants in each group will
        cross over to the other group.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change in Gait Speed
  time frame: Week 1, Week 6, Week 12
  description: The Timed 25-Foot Walk Test (T25FWT) to record duration of time to walk a distance of 25 feet, measured in seconds. The score is the average of two successive trials.
  measure: Change in Perceived Walking Ability
  time frame: Week 1, Week 6, Week 12
  description: Multiple Sclerosis Walking Scale-12 (MSWS-12) to measure perceived impact of MS on walking ability, measured by score. Scores on the MSWS-12 range from 12-60 and transformed to a scale with a range from 0 to 100, with high scores indicative of a greater impact of MS on walking.
  measure: Change in MS Disability
  time frame: Day 0, Week 6, Week 12
  description: Expanded Disability Status Scale (EDSS), administered by a trained clinician, to quantify disability in MS and monitor changes in the level of disability over time. The EDSS scale ranges from 0 to 10, with high scores indicative of higher levels of disability.
  measure: Change in Fall Risk
  time frame: Week 1, Week 6, Week 12
  description: Berg Balance Scale (BBS) to assess balance in 14 tasks, measured by score. Scores of the BBS range from 0 to 56, with 0-20 being wheelchair bound, 21-40 being walking with assistance, and 41-56 classified as independent.
  measure: Amount of Daily Walking/Activity Level
  time frame: Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16
  description: Collected by the usage log of the device(s), measured in steps per day
  measure: Duration of Daily Walking/Activity Level
  time frame: Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16
  description: Collected by the usage log of the device(s), measured in duration of activity.
  measure: Change in Health-Related Quality of Life
  time frame: Day 0, Week 6, Week 12
  description: The Euroqol 5 Dimension 5 Level (EQ-5D-5L) questionnaire describes health profiles using different domains, measured by a 5-digit code. Single-digit numbers of the dimensions range from 1 to 5, with 1 indicative of no problem and 5 indicative of extreme problems in that domain.
  measure: Change in Impact of MS
  time frame: Day 0, Week 6, Week 12
  description: Multiple Sclerosis Impact Scale-29 (MSIS-29) questionnaire to measure the physical and psychological impact of MS, measured by score. Scores on the MSIS-29 are transformed into a score out of 100, with higher scores indicative of greater degree of disability.
  measure: Change in Perceived Fatigue
  time frame: Day 0, Week 6, Week 12
  description: Modified Fatigue Impact Scale (MFIS) survey to measure the effects of fatigue in physical, cognitive, and psychosocial functioning. MFIS score ranges from 0 to 84, with high scores indicative of a greater impact of fatigue on activities.
  measure: Change in Spasticity
  time frame: Week 1, Week 6, Week 12
  description: A trained clinician will administer the Modified Ashworth Scale (MAS) to assess for muscle tone and spasticity. Scores of the MAS range from 0 to 4, with high scores representative of increased muscle tone and spasticity.
  measure: Change in Lower Limb Strength
  time frame: Week 1, Week 6, Week 12
  description: Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons.
  measure: Change in Ankle Plantarflexor Strength
  time frame: Week 1, Week 6, Week 12
  description: Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises.
  measure: Change in Lower Limb Range of Motion
  time frame: Week 1, Week 6, Week 12
  description: Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer.
  measure: Change in Walking Endurance
  time frame: Week 1, Week 6, Week 12
  description: Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters.
  measure: Change in Balance
  time frame: Week 1, Week 6, Week 12
  description: Measured using force platform posturography in standing to quantify postural sway. There will be four 30-second trials with eyes open standing as still as possible.
  measure: Change in Blood Lipids
  time frame: Week 1, Week 6, Week 12
  description: Measured utilizing point of care analysis. The Cholestech LDX Analyzer provides accurate, actionable, and readily accessible results for point-of-care lipid profile and cholesterol testing, measured in milligrams per deciliter. Rapid, accurate results provide immediate awareness and identification of cardiovascular and diabetes health risks in only 5 minutes.
  measure: Change in Blood Glucose
  time frame: Week 1, Week 6, Week 12
  description: Measured utilizing point of care analysis. The Cholestech LDX Analyzer provides accurate, actionable, and readily accessible results for point-of-care glucose testing, measured in milligrams per deciliter. Rapid, accurate results provide immediate awareness and identification of cardiovascular and diabetes health risks in only 5 minutes.
  measure: Change in Incidence of Falls
  time frame: From enrollment to end of treatment at 12 weeks, post-intervention at Week 16
  description: Measured using a self-reported fall diary and a survey, the Hopkins Fall Grading Scale, a 4-point scale to grade the nature and severity of a fall. Higher grades represent increased severity and impact of injurious falls.
  measure: Change in Medication(s) and Dosage
  time frame: Day 0, Week 1, Week 6, Week 12, post-intervention at Week 16
  description: Measured by changes in dose intensities of prescribed medication(s).
  measure: Change in Pain
  time frame: Week 1, Week 6, Week 12
  description: Measured using the questionnaire, the Numeric Pain Rating Scale (NPRS), an 11-point numeric scale ranging from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.
  measure: Change in Self-Reported Physical Activity
  time frame: From enrollment to end of treatment at 12 weeks, post-intervention at Week 16
  description: Subjects will record their weekly physical activity using the Godin-Leisure Time Exercise Questionnaire (GLTEQ), measured by score. Scores less than 14 units are interpreted as insufficiently active/sedentary, while scores between 14 and 23 are interpreted as moderately active, and scores greater than 24 units are interpreted as active.
  arm group label: Control
  arm group type: Experimental
  description: Participants will follow the walking program.
  arm group label: Functional electrical stimulation
  arm group type: Experimental
  description: Participants will follow the walking program and receive stimulation assistance during the walking sessions.
  intervention type: Device
  intervention name: Cionic Neural Sleeve NS-100
  description: The Cionic Neural Sleeve applies functional electrical stimulation as subjects walk to help contract appropriate muscles at appropriate times. The Cionic Neural Sleeve will be worn for 6 weeks.
  arm group label: Functional electrical stimulation
  intervention type: Device
  intervention name: Actigraph accelerometer
  description: Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.
  arm group label: Control
  arm group label: Functional electrical stimulation
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Douglas A Wajda, PhD
  role: Principal Investigator
  affiliation: Cleveland State University
  last name: Douglas A Wajda, PhD
  phone: 3308837149
  email: d.a.wajda@csuohio.edu
  last name: Rebecca Webster, PhD
  phone: 925-788-6649
  email: rebecca@cionic.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Multiple Sclerosis, Relapsing-Remitting
  mesh term: Multiple Sclerosis, Chronic Progressive
  mesh term: Sclerosis
  sharing ipd: No