<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/NCT02227524</url>
  </required_header>
  <id_info>
    <org_study_id>Pro201300052</org_study_id>
    <nct_id>NCT02227524</nct_id>
  </id_info>
  <brief_title>Trekking Poles to Aid Multiple Sclerosis Gait Impairment</brief_title>
  <acronym>TRAMS</acronym>
  <official_title>Trekking Poles to Aid Multiple Sclerosis Gait Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rowan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rowan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators will examine a sample of persons with multiple sclerosis&#xD;
      (MS) to determine whether their walking function and ability is different depending on which&#xD;
      walking assistive device is used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators will examine a sample of persons with multiple sclerosis&#xD;
      (MS) to determine whether their walking function and ability is different depending on which&#xD;
      walking assistive device is used. In addition, the investigators will examine the&#xD;
      psychosocial impact and amount of fatigue induced by each assistive device. Data collection&#xD;
      will consist of a series of assessments via survey and physical performance. The analyses&#xD;
      will consist of appropriate comparisons of means to determine if the use of different&#xD;
      assistive devices alters any of the outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">March 7, 2019</completion_date>
  <primary_completion_date type="Actual">March 7, 2019</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>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite measures of walking</measure>
    <time_frame>1 year</time_frame>
    <description>Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>No Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assistive device conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Point Cane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assistive device condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Four-Point Cane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assistive device condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trekking Pole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assistive device condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No device</intervention_name>
    <description>Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).</description>
    <arm_group_label>Four-Point Cane</arm_group_label>
    <arm_group_label>No Device</arm_group_label>
    <arm_group_label>Single Point Cane</arm_group_label>
    <arm_group_label>Trekking Pole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Single-point cane (SPC)</intervention_name>
    <description>Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).</description>
    <arm_group_label>Four-Point Cane</arm_group_label>
    <arm_group_label>No Device</arm_group_label>
    <arm_group_label>Single Point Cane</arm_group_label>
    <arm_group_label>Trekking Pole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Four-point cane (FPC)</intervention_name>
    <description>Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).</description>
    <arm_group_label>Four-Point Cane</arm_group_label>
    <arm_group_label>No Device</arm_group_label>
    <arm_group_label>Single Point Cane</arm_group_label>
    <arm_group_label>Trekking Pole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trekking pole (TP).</intervention_name>
    <description>Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).</description>
    <arm_group_label>Four-Point Cane</arm_group_label>
    <arm_group_label>No Device</arm_group_label>
    <arm_group_label>Single Point Cane</arm_group_label>
    <arm_group_label>Trekking Pole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 18-64 years old with a confirmed diagnosis of MS&#xD;
&#xD;
          -  Have perceived walking difficulty&#xD;
&#xD;
          -  Have an EDSS score of &lt; 6, calculated by the physician&#xD;
&#xD;
          -  Ability to understand study procedures and to comply with them for the entire length&#xD;
             of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have had a MS exacerbation in the prior 8 weeks&#xD;
&#xD;
          -  Have other serious medical conditions that would impair their ability to participate&#xD;
             in gait performance testing (i.e. severe rheumatoid arthritis or osteoarthritis)&#xD;
&#xD;
          -  If the physician deems a participant unsafe to go home with devices&#xD;
&#xD;
          -  Cannot communicate in English&#xD;
&#xD;
          -  Possess greater than a mild decrease in mentation (i.e. a score of &gt;2 on the Mental&#xD;
             Functions item of the FSS)&#xD;
&#xD;
          -  Inability or unwillingness of individual to give written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donald Barone, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rowan University School of Osteopathic Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rowan University School of Osteopathic Medicine</name>
      <address>
        <city>Stratford</city>
        <state>New Jersey</state>
        <zip>08084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>October 24, 2019</last_update_submitted>
  <last_update_submitted_qc>October 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rowan University</investigator_affiliation>
    <investigator_full_name>Lauren Fedor</investigator_full_name>
    <investigator_title>Program Manager</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Walking</keyword>
  <keyword>Gait</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</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>


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/NCT02227524
org study id: Pro201300052
nct id: NCT02227524
lead sponsor: 
has dmc: No
In this study, the investigators will examine a sample of persons with multiple sclerosis
      (MS) to determine whether their walking function and ability is different depending on which
      walking assistive device is used.
In this study, the investigators will examine a sample of persons with multiple sclerosis
      (MS) to determine whether their walking function and ability is different depending on which
      walking assistive device is used. In addition, the investigators will examine the
      psychosocial impact and amount of fatigue induced by each assistive device. Data collection
      will consist of a series of assessments via survey and physical performance. The analyses
      will consist of appropriate comparisons of means to determine if the use of different
      assistive devices alters any of the outcomes.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: None (Open Label)
measure: Composite measures of walking
time frame: 1 year
description: Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)
arm group label: No Device
arm group type: Experimental
description: Assistive device conditions
arm group label: Single Point Cane
arm group type: Experimental
description: Assistive device condition
arm group label: Four-Point Cane
arm group type: Experimental
description: Assistive device condition
arm group label: Trekking Pole
arm group type: Experimental
description: Assistive device condition
intervention type: Other
intervention name: No device
description: Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
arm group label: Four-Point Cane
arm group label: No Device
arm group label: Single Point Cane
arm group label: Trekking Pole
intervention type: Device
intervention name: Single-point cane (SPC)
description: Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
arm group label: Four-Point Cane
arm group label: No Device
arm group label: Single Point Cane
arm group label: Trekking Pole
intervention type: Device
intervention name: Four-point cane (FPC)
description: Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
arm group label: Four-Point Cane
arm group label: No Device
arm group label: Single Point Cane
arm group label: Trekking Pole
intervention type: Device
intervention name: Trekking pole (TP).
description: Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
arm group label: Four-Point Cane
arm group label: No Device
arm group label: Single Point Cane
arm group label: Trekking Pole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Donald Barone, DO
role: Principal Investigator
affiliation: Rowan University School of Osteopathic Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rowan University
investigator full name: Lauren Fedor
investigator title: Program Manager
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No