<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/NCT03801473</url>
  </required_header>
  <id_info>
    <org_study_id>Tugba Ozsoy</org_study_id>
    <nct_id>NCT03801473</nct_id>
  </id_info>
  <brief_title>Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients</brief_title>
  <official_title>Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey</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>
      The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait&#xD;
      training program in terms of fatigue, anxiety, depression and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training&#xD;
      with robot assisted technology is used for rehabilitation. In several studies conventional&#xD;
      rehabilitation was compared with robot assisted rehabilitation program, and they found no&#xD;
      superior effects of robot assisted walking program. In this study we aimed to compare these&#xD;
      modalities in terms of fatigue, anxiety and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Initial assessments will be performed by first clinician (EA). Then, patients will be randomly grouped. The outcome assessor, second clinician (TOU) will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue Severity Score</measure>
    <time_frame>baseline</time_frame>
    <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Severity Score</measure>
    <time_frame>after treatment (4th week)</time_frame>
    <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue Severity Score</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)</measure>
    <time_frame>Baseline</time_frame>
    <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)</measure>
    <time_frame>After treatment (4th week)</time_frame>
    <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)</measure>
    <time_frame>baseline</time_frame>
    <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)</measure>
    <time_frame>After treatment (4th week)</time_frame>
    <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health</measure>
    <time_frame>baseline</time_frame>
    <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health</measure>
    <time_frame>after treatment (4th week)</time_frame>
    <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded Disability Status Scale (EDSS)</measure>
    <time_frame>baseline</time_frame>
    <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded Disability Status Scale (EDSS)</measure>
    <time_frame>after treatment (4th week)</time_frame>
    <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expanded Disability Status Scale (EDSS)</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Ambulation Classification</measure>
    <time_frame>baseline</time_frame>
    <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Ambulation Classification</measure>
    <time_frame>after treatment (4th week)</time_frame>
    <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Ambulation Classification</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Ability</measure>
    <time_frame>baseline</time_frame>
    <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Ability</measure>
    <time_frame>after treatment (4th week)</time_frame>
    <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Ability</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Test (BBT)</measure>
    <time_frame>Baseline</time_frame>
    <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Test (BBT)</measure>
    <time_frame>After treatment (4th week)</time_frame>
    <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Test (BBT)</measure>
    <time_frame>3 months after treatment</time_frame>
    <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>robot assisted training (RAT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional training (CT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>robot assisted gait therapy</intervention_name>
    <description>The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.</description>
    <arm_group_label>robot assisted training (RAT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional rehabilitation</intervention_name>
    <description>Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.</description>
    <arm_group_label>conventional training (CT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-70 years old Multiple Sclerosis patients&#xD;
&#xD;
          -  EDSS score: 5.5-7.5&#xD;
&#xD;
          -  Being oriented and cooperated&#xD;
&#xD;
          -  Mini-mental score ≥24/30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Modified Ashworth &gt;3 in lower extremity muscles&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Botox injection within last 6-months&#xD;
&#xD;
          -  Having another neurological disease&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sultan Abdulhamid Han Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Lefeber N, Swinnen E, Kerckhofs E. The immediate effects of robot-assistance on energy consumption and cardiorespiratory load during walking compared to walking without robot-assistance: a systematic review. Disabil Rehabil Assist Technol. 2017 Oct;12(7):657-671. doi: 10.1080/17483107.2016.1235620. Epub 2016 Oct 20.</citation>
    <PMID>27762641</PMID>
  </reference>
  <reference>
    <citation>Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.</citation>
    <PMID>28241776</PMID>
  </reference>
  <reference>
    <citation>Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014.</citation>
    <PMID>24904361</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>December 30, 2020</results_first_submitted>
  <results_first_submitted_qc>February 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 2, 2021</results_first_posted>
  <last_update_submitted>April 11, 2021</last_update_submitted>
  <last_update_submitted_qc>April 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rehabilitation</keyword>
  <keyword>robot assisted gait training</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03801473/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Robot Assisted Gait</title>
          <description>robot assisted gait therapy: The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.</description>
        </group>
        <group group_id="P2">
          <title>Conventional Rehabilitation</title>
          <description>Conventional rehabilitation: Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Robot Assisted Training (RAT)</title>
          <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
        </group>
        <group group_id="B2">
          <title>Conventional Training (CT)</title>
          <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45" spread="9.2"/>
                    <measurement group_id="B2" value="44.7" spread="8.4"/>
                    <measurement group_id="B3" value="44.8" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.1" spread="5.9"/>
                    <measurement group_id="B2" value="13.4" spread="6.2"/>
                    <measurement group_id="B3" value="13.7" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fatigue Severity Score</title>
        <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Fatigue Severity Score</title>
          <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4.11" upper_limit="7"/>
                    <measurement group_id="O2" value="6" lower_limit="4.11" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fatigue Severity Score</title>
        <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
        <time_frame>after treatment (4th week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Fatigue Severity Score</title>
          <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="3.00" upper_limit="6.44"/>
                    <measurement group_id="O2" value="5.8" lower_limit="3.89" upper_limit="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fatigue Severity Score</title>
        <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
        <time_frame>3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Fatigue Severity Score</title>
          <description>Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3.33" upper_limit="7"/>
                    <measurement group_id="O2" value="5.7" lower_limit="4" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)</title>
        <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)</title>
          <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O2" value="10" lower_limit="1" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)</title>
        <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
        <time_frame>After treatment (4th week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)</title>
          <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O2" value="9" lower_limit="1" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)</title>
        <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
        <time_frame>3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)</title>
          <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="0" upper_limit="13"/>
                    <measurement group_id="O2" value="9" lower_limit="1" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)</title>
        <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)</title>
          <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="3" upper_limit="13"/>
                    <measurement group_id="O2" value="8" lower_limit="3" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)</title>
        <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
        <time_frame>After treatment (4th week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)</title>
          <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="1" upper_limit="17"/>
                    <measurement group_id="O2" value="8" lower_limit="3" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)</title>
        <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
        <time_frame>3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)</title>
          <description>Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).&#xD;
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="15"/>
                    <measurement group_id="O2" value="8" lower_limit="2" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health</title>
        <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health</title>
          <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" lower_limit="14.4" upper_limit="65.1"/>
                    <measurement group_id="O2" value="29.9" lower_limit="10.8" upper_limit="63.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health</title>
        <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
        <time_frame>after treatment (4th week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health</title>
          <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2" lower_limit="16.7" upper_limit="70.8"/>
                    <measurement group_id="O2" value="33.7" lower_limit="16.2" upper_limit="73.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health</title>
        <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
        <time_frame>3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health</title>
          <description>The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.&#xD;
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.&#xD;
The summary scores are the physical health composite summary and the mental health composite summary.&#xD;
Each composite summary scored 0-100. Higher values indicate better QoL.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9" lower_limit="17.1" upper_limit="70.8"/>
                    <measurement group_id="O2" value="29.1" lower_limit="16.2" upper_limit="65.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expanded Disability Status Scale (EDSS)</title>
        <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Expanded Disability Status Scale (EDSS)</title>
          <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="5.5" upper_limit="7"/>
                    <measurement group_id="O2" value="6" lower_limit="5.5" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expanded Disability Status Scale (EDSS)</title>
        <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
        <time_frame>after treatment (4th week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Expanded Disability Status Scale (EDSS)</title>
          <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="5.5" upper_limit="7"/>
                    <measurement group_id="O2" value="6" lower_limit="5.5" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expanded Disability Status Scale (EDSS)</title>
        <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
        <time_frame>3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Expanded Disability Status Scale (EDSS)</title>
          <description>The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="5" upper_limit="7"/>
                    <measurement group_id="O2" value="6" lower_limit="5.5" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Ambulation Classification</title>
        <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Ambulation Classification</title>
          <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Ambulation Classification</title>
        <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
        <time_frame>after treatment (4th week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Ambulation Classification</title>
          <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Ambulation Classification</title>
        <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
        <time_frame>3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Ambulation Classification</title>
          <description>scored 0 to 5 (non functional ambulator to independant ambulator)</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Walking Ability</title>
        <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Walking Ability</title>
          <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" lower_limit="0" upper_limit="200"/>
                    <measurement group_id="O2" value="60" lower_limit="1" upper_limit="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Walking Ability</title>
        <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
        <time_frame>after treatment (4th week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Walking Ability</title>
          <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="1" upper_limit="210"/>
                    <measurement group_id="O2" value="70" lower_limit="5" upper_limit="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Walking Ability</title>
        <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
        <time_frame>3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Walking Ability</title>
          <description>The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.</description>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="1" upper_limit="210"/>
                    <measurement group_id="O2" value="65" lower_limit="5" upper_limit="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Berg Balance Test (BBT)</title>
        <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Berg Balance Test (BBT)</title>
          <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="0" upper_limit="39"/>
                    <measurement group_id="O2" value="15" lower_limit="5" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Berg Balance Test (BBT)</title>
        <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
        <time_frame>After treatment (4th week)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Berg Balance Test (BBT)</title>
          <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" lower_limit="2" upper_limit="42"/>
                    <measurement group_id="O2" value="18" lower_limit="8" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Berg Balance Test (BBT)</title>
        <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
        <time_frame>3 months after treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robot Assisted Training (RAT)</title>
            <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
          </group>
          <group group_id="O2">
            <title>Conventional Training (CT)</title>
            <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
          </group>
        </group_list>
        <measure>
          <title>Berg Balance Test (BBT)</title>
          <description>Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" lower_limit="2" upper_limit="40"/>
                    <measurement group_id="O2" value="18" lower_limit="8" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were not monitored/assessed</time_frame>
      <desc>Adverse Events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Robot Assisted Training (RAT)</title>
          <description>RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities</description>
        </group>
        <group group_id="E2">
          <title>Conventional Training (CT)</title>
          <description>Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tugba Ozsoy</name_or_title>
      <organization>Sultan Abdulhamid Han Training and Research Hospital</organization>
      <phone>+902165422020 ext 3876</phone>
      <email>tugbaozsoyy@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03801473
org study id: Tugba Ozsoy
nct id: NCT03801473
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait
      training program in terms of fatigue, anxiety, depression and quality of life.
Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training
      with robot assisted technology is used for rehabilitation. In several studies conventional
      rehabilitation was compared with robot assisted rehabilitation program, and they found no
      superior effects of robot assisted walking program. In this study we aimed to compare these
      modalities in terms of fatigue, anxiety and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Initial assessments will be performed by first clinician (EA). Then, patients will be randomly grouped. The outcome assessor, second clinician (TOU) will be blinded.
measure: Fatigue Severity Score
time frame: baseline
description: Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
measure: Fatigue Severity Score
time frame: after treatment (4th week)
description: Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
measure: Fatigue Severity Score
time frame: 3 months after treatment
description: Patient-reported outcome measure which is composed of 9 items and evaluates the severity of fatigue. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The minimum score is 9 and maximum possible score is 63. FSS score is calculated as total score/9. Higher score reflects greater fatigue severity.
measure: Hospital Anxiety Depression Scale-Depression Subscale (HADS-D)
time frame: Baseline
description: Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
measure: Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
time frame: After treatment (4th week)
description: Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
measure: Hospital Anxiety Depression Scale- Depression Subscale (HADS-D)
time frame: 3 months after treatment
description: Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-D sub-scale has seven items and each item is scored on a scale of 0 to 3. Total score ranged from 0 to 21. Higher scores reflects more severe depression.
measure: Hospital Anxiety Depression Scale- Anxiety Subscale (HADS-A)
time frame: baseline
description: Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
measure: Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
time frame: After treatment (4th week)
description: Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
measure: Hospital Anxiety Depression Scale-Anxiety Subscale (HADS-A)
time frame: 3 months after treatment
description: Hospital Anxiety Depression Scale (HADS) s a 14 item questionnaire which consists two sub-scale evaluating anxiety (HADS-A) and depression (HADS-D).
HADS-A sub-scale has seven items and each item is scored on a scale of 0 to 3. Total sub-scale score ranged from 0 to 21. Higher score mean a worse outcome.
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
time frame: baseline
description: The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.
The summary scores are the physical health composite summary and the mental health composite summary.
Each composite summary scored 0-100. Higher values indicate better QoL.
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)-Physical Health
time frame: after treatment (4th week)
description: The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.
The summary scores are the physical health composite summary and the mental health composite summary.
Each composite summary scored 0-100. Higher values indicate better QoL.
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)- Physical Health
time frame: 3 months after treatment
description: The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items.
This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function.
The summary scores are the physical health composite summary and the mental health composite summary.
Each composite summary scored 0-100. Higher values indicate better QoL.
measure: Expanded Disability Status Scale (EDSS)
time frame: baseline
description: The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
measure: Expanded Disability Status Scale (EDSS)
time frame: after treatment (4th week)
description: The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
measure: Expanded Disability Status Scale (EDSS)
time frame: 3 months after treatment
description: The EDSS assesses the disability status of MS patients on a scale range from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
measure: Functional Ambulation Classification
time frame: baseline
description: scored 0 to 5 (non functional ambulator to independant ambulator)
measure: Functional Ambulation Classification
time frame: after treatment (4th week)
description: scored 0 to 5 (non functional ambulator to independant ambulator)
measure: Functional Ambulation Classification
time frame: 3 months after treatment
description: scored 0 to 5 (non functional ambulator to independant ambulator)
measure: Walking Ability
time frame: baseline
description: The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
measure: Walking Ability
time frame: after treatment (4th week)
description: The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
measure: Walking Ability
time frame: 3 months after treatment
description: The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
measure: Berg Balance Test (BBT)
time frame: Baseline
description: Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
measure: Berg Balance Test (BBT)
time frame: After treatment (4th week)
description: Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
measure: Berg Balance Test (BBT)
time frame: 3 months after treatment
description: Berg Balance Test (BBT) is a functional test with 14 items. Each item is scored on a five point scale (0 to 4) which is determined by ability to perform the task. The total score ranged 0 to 56. A higher score reflects better functional balance.
arm group label: robot assisted training (RAT)
arm group type: Experimental
description: RoboGait which is an automated locomotor therapy system was used for treating RAT group. The system composed of a robotic lower extremity orthosis, adjustable dynamic gait support, synchronized treadmill and biofeedback utilities
arm group label: conventional training (CT)
arm group type: Active Comparator
description: Participants in CT group had physiotherapist assisted walking exercises on the parallel bars and on the ground with aids/cane, tripod or walker.
intervention type: Other
intervention name: robot assisted gait therapy
description: The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.
arm group label: robot assisted training (RAT)
intervention type: Other
intervention name: Conventional rehabilitation
description: Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
arm group label: conventional training (CT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Lefeber N, Swinnen E, Kerckhofs E. The immediate effects of robot-assistance on energy consumption and cardiorespiratory load during walking compared to walking without robot-assistance: a systematic review. Disabil Rehabil Assist Technol. 2017 Oct;12(7):657-671. doi: 10.1080/17483107.2016.1235620. Epub 2016 Oct 20.
PMID: 27762641
citation: Straudi S, Manfredini F, Lamberti N, Zamboni P, Bernardi F, Marchetti G, Pinton P, Bonora M, Secchiero P, Tisato V, Volpato S, Basaglia N. The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial. Trials. 2017 Feb 27;18(1):88. doi: 10.1186/s13063-017-1838-2.
PMID: 28241776
citation: Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014.
PMID: 24904361
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 