<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/NCT03230903</url>
  </required_header>
  <id_info>
    <org_study_id>AAAQ7693</org_study_id>
    <secondary_id>MS150167</secondary_id>
    <nct_id>NCT03230903</nct_id>
  </id_info>
  <brief_title>Physical Telerehabilitation in Multiple Sclerosis</brief_title>
  <official_title>Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated&#xD;
      Telemanagement) System as an adjunct to the current standard of medical care for patients&#xD;
      with MS (PwMS). The individual patient with MS will be the unit of analysis. For each&#xD;
      participant, the investigators will assess the effect of Home Automated Telemanagement (HAT)&#xD;
      on functional outcomes, levels of disablement including impairment, activity and&#xD;
      participation, socio-behavioral parameters, and satisfaction with medical care as described&#xD;
      below.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People with multiple sclerosis may develop severe disability over the time. Physical therapy&#xD;
      including regular exercise helps patients with severe disability to maintain muscle strength,&#xD;
      reduce disease symptoms and improve quality of life. However physical therapy programs at&#xD;
      clinical settings require constant travel which may limit access of patients with mobility&#xD;
      disability to these services on continuous basis.Technology can allow patients with mobility&#xD;
      disability exercise at home under supervision of their rehabilitation team. Currently it is&#xD;
      unclear how effective this approach is. The study aims to demonstrate that the patients who&#xD;
      were helped by the new technology to exercise at home will have better fitness, less symptoms&#xD;
      and better quality of life. If so, other patients with significant mobility disability will&#xD;
      be able to take advantage of this technology. This approach can be extended to people with&#xD;
      different diseases causing mobility impairment and it can be used not only for physical but&#xD;
      also for cognitive and occupational rehabilitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">September 2020</completion_date>
  <primary_completion_date type="Actual">September 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiorespiratory fitness</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Cardiorespiratory fitness will be measured by oxygen consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MS Self-efficacy scale</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>MS Self-efficacy scale is a 14-point questionnaire designed to assess the psychological adjustment and quality-of-life of individuals with MS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise adherence</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>The CES-D is a 20 point questionnaire based on self-reported frequency of symptoms related to depression during the past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale (BBS)</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>BBS is a clinical 14-item scale designed to measure balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-Minute Walk Test (2MWT)</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>Total distance walked in meters will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Home Telerehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The physical telerehabilitation group will receive an exercise plan, exercise equipment, a computer, and access to a daily individualized exercise plan. Participants in this group will follow the exercise plan that is sent to their computer via the telerehabilitation software. Participants will have interactions with a physical therapist and an exercise physiologist throughout training intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The usual care group will receive an individualized exercise program at baseline however participants will not receive the home telerehabilitation system or exercise equipment. Participants assigned to the usual care group will also not have access to the study physical therapist or exercise physiologist during the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home telerehabilitation</intervention_name>
    <description>Patients will receive an individualized exercise plan sent to a computer at their home. Patients will have daily access to a physical therapist and exercise physiologist.</description>
    <arm_group_label>Home Telerehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;21&#xD;
&#xD;
          -  Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria&#xD;
&#xD;
          -  EDSS range 5.0-8.0&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) &gt; 22 or presence of a caregiver to assist in&#xD;
             daily exercise regimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coronary artery disease&#xD;
&#xD;
          -  Congestive Heart Failure&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Pacemaker or implanted defibrillator&#xD;
&#xD;
          -  Unstable fractures or other musculoskeletal diagnoses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Stein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Joel Stein, MD</investigator_full_name>
    <investigator_title>Simon Baruch Professor of Physical Medicine &amp; Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Telerehabilitation</keyword>
  <keyword>Physical rehabilitation</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>Undecided</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/NCT03230903
org study id: AAAQ7693
secondary id: MS150167
nct id: NCT03230903
lead sponsor: 
collaborator: 
has dmc: Yes
The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated
      Telemanagement) System as an adjunct to the current standard of medical care for patients
      with MS (PwMS). The individual patient with MS will be the unit of analysis. For each
      participant, the investigators will assess the effect of Home Automated Telemanagement (HAT)
      on functional outcomes, levels of disablement including impairment, activity and
      participation, socio-behavioral parameters, and satisfaction with medical care as described
      below.
People with multiple sclerosis may develop severe disability over the time. Physical therapy
      including regular exercise helps patients with severe disability to maintain muscle strength,
      reduce disease symptoms and improve quality of life. However physical therapy programs at
      clinical settings require constant travel which may limit access of patients with mobility
      disability to these services on continuous basis.Technology can allow patients with mobility
      disability exercise at home under supervision of their rehabilitation team. Currently it is
      unclear how effective this approach is. The study aims to demonstrate that the patients who
      were helped by the new technology to exercise at home will have better fitness, less symptoms
      and better quality of life. If so, other patients with significant mobility disability will
      be able to take advantage of this technology. This approach can be extended to people with
      different diseases causing mobility impairment and it can be used not only for physical but
      also for cognitive and occupational rehabilitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Cardiorespiratory fitness
time frame: Baseline up to 6 months
description: Cardiorespiratory fitness will be measured by oxygen consumption
measure: MS Self-efficacy scale
time frame: Baseline up to 6 months
description: MS Self-efficacy scale is a 14-point questionnaire designed to assess the psychological adjustment and quality-of-life of individuals with MS.
measure: Exercise adherence
time frame: Baseline up to 6 months
description: Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed.
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: Baseline up to 6 months
description: The CES-D is a 20 point questionnaire based on self-reported frequency of symptoms related to depression during the past week.
measure: Berg Balance Scale (BBS)
time frame: Baseline up to 6 months
description: BBS is a clinical 14-item scale designed to measure balance
measure: 2-Minute Walk Test (2MWT)
time frame: Baseline up to 6 months
description: Total distance walked in meters will be recorded.
arm group label: Home Telerehabilitation
arm group type: Experimental
description: The physical telerehabilitation group will receive an exercise plan, exercise equipment, a computer, and access to a daily individualized exercise plan. Participants in this group will follow the exercise plan that is sent to their computer via the telerehabilitation software. Participants will have interactions with a physical therapist and an exercise physiologist throughout training intervention.
arm group label: Usual Care
arm group type: Sham Comparator
description: The usual care group will receive an individualized exercise program at baseline however participants will not receive the home telerehabilitation system or exercise equipment. Participants assigned to the usual care group will also not have access to the study physical therapist or exercise physiologist during the intervention.
intervention type: Other
intervention name: Home telerehabilitation
description: Patients will receive an individualized exercise plan sent to a computer at their home. Patients will have daily access to a physical therapist and exercise physiologist.
arm group label: Home Telerehabilitation
intervention type: Other
intervention name: Usual Care
description: Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Joel Stein, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Joel Stein, MD
investigator title: Simon Baruch Professor of Physical Medicine & Rehabilitation
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided