<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/NCT02202538</url>
  </required_header>
  <id_info>
    <org_study_id>PH-IND01</org_study_id>
    <nct_id>NCT02202538</nct_id>
  </id_info>
  <brief_title>Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).</brief_title>
  <acronym>Indego</acronym>
  <official_title>Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parker Hannifin Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Parker Hannifin Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the Indego® device for safety and effectiveness at allowing persons&#xD;
      with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study</measure>
    <time_frame>4 weeks, 8 weeks</time_frame>
    <description>Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Up and Go (TUG) Test</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Time to Don/Doff Device</measure>
    <time_frame>8 weeks</time_frame>
    <description>Time needed for an individual to don or doff the device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects That Could Don/Doff the Device Independently</measure>
    <time_frame>8 weeks</time_frame>
    <description>The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking Index for Spinal Cord Injury (WISCI-II) Assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.&#xD;
0:unable&#xD;
parallel bars, braces, help of 2 persons,&lt;10m&#xD;
parallel bars, braces, help of 2 persons,10m&#xD;
parallel bars, braces, help of 1 person,10m&#xD;
parallel bars, no braces, help of 1 person,10m&#xD;
parallel bars, braces, no help,10m&#xD;
walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m&#xD;
8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m&#xD;
Reference: rehabmeasures.org</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM) Score for Walking Indoors</measure>
    <time_frame>8 weeks</time_frame>
    <description>FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.&#xD;
7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance&#xD;
1: total assistance&#xD;
Reference: rehabmeasures.org</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Borg Rating of Perceived Exertion (BRPE) for Walking Indoors</measure>
    <time_frame>8 weeks</time_frame>
    <description>The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.&#xD;
6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Indego</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Indego</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Indego</intervention_name>
    <description>Indego</description>
    <arm_group_label>Indego</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 18 years or older&#xD;
&#xD;
          -  Height 5'1&quot; to 6'3&quot; (Acceptable height may vary by a few inches depending on femur&#xD;
             length).&#xD;
&#xD;
          -  Hip width as measured in sitting no greater than 16.6&quot; (42 cm) (acceptable hip width&#xD;
             may vary depending on soft tissue).&#xD;
&#xD;
          -  Femur length as measured in sitting must be between 14 inches (35.5cm) and 18.5 inches&#xD;
             (47 cm)&#xD;
&#xD;
          -  Weight 250lbs (113.4 kg) or less&#xD;
&#xD;
          -  Present with Spinal Cord Injury and NLI C5 and lower, with ISNCSCI A, B, C or D who&#xD;
             are non-ambulatory or poorly ambulatory.&#xD;
&#xD;
          -  There are no restrictions on time since injury. However, each subject must have signed&#xD;
             medical clearance/approval for full weight bearing and locomotor training.&#xD;
&#xD;
          -  Determined to have sufficient bone health for walking with full weight bearing without&#xD;
             undue risk for fracture. Meeting of this criterion is at the discretion of each&#xD;
             subject's personal MD and must be approved by each site's Medical PI.&#xD;
&#xD;
          -  Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower&#xD;
             extremities within functional limits for safe gait and use of appropriate assistive&#xD;
             device/stability aid.&#xD;
&#xD;
          -  Skin must be intact where it interfaces with robotic device&#xD;
&#xD;
          -  Modified Ashworth Scale for spasticity score must be 3 or less.&#xD;
&#xD;
          -  Blood pressure and heart rate within established guidelines for locomotor training:&#xD;
&#xD;
               -  At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less&#xD;
&#xD;
               -  Exercise; Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less&#xD;
&#xD;
          -  Tolerate being in an upright standing position (passive or active) without being&#xD;
             lightheaded or having a headache.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight in excess of 250 lbs&#xD;
&#xD;
          -  Heterotopic ossification that, in the opinion of the investigator, would place the&#xD;
             subject at undue risk for fracture.&#xD;
&#xD;
          -  Any subject deemed at increased risk for injury by Medical Personnel&#xD;
&#xD;
          -  Lower extremity joint limitation that exceeds 10 degrees at their hips, knees or&#xD;
             ankles.&#xD;
&#xD;
          -  Light headedness or headache in standing position (active or passive)&#xD;
&#xD;
          -  Moderate to Severe Traumatic (or Acquired) Brain Injury&#xD;
&#xD;
          -  Inability to follow instructions&#xD;
&#xD;
          -  Colostomy bag&#xD;
&#xD;
          -  Women who are pregnant or attempting to become pregnant during the study intervention.&#xD;
&#xD;
          -  Unable to obtain informed consent (either from the subject or from the subjects&#xD;
             Legally Authorized Representative).&#xD;
&#xD;
          -  Any disease, concomitant injury, or condition that interferes with the performance or&#xD;
             interpretation of the protocol specified assessments&#xD;
&#xD;
          -  Unlikely to be available for follow-up phone call.&#xD;
&#xD;
          -  Any other issue which, in the opinion of the investigators, will make the subject&#xD;
             unsuitable for study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Craig Hospital</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shepherd Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehabilitation Institue of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kessler Institute for Rehabilitation</name>
      <address>
        <city>West Orange</city>
        <state>New Jersey</state>
        <zip>07052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RUSK Rehabilitation Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>October 26, 2016</results_first_submitted>
  <results_first_submitted_qc>October 26, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 20, 2016</results_first_posted>
  <last_update_submitted>June 26, 2017</last_update_submitted>
  <last_update_submitted_qc>June 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SCI</keyword>
  <keyword>Indego</keyword>
  <keyword>Walking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were screened and enrolled at five sites in the United States</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>All Subjects</title>
          <description>All subjects enrolled in the study used the Indego</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet all inclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>All subjects enrolled in the study used the Indego</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.9" spread="13.0"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Level of Injury</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>T3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>L1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>L2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASIA Impairment Scale Score</title>
          <description>A: motor and sensory complete injury B: motor complete and sensory incomplete injury C: motor and sensory incomplete injury; half or more than half of affected muscles are less than grade 3/5 D: motor and sensory incomplete injury; half or more than half of affected muscles are more than grade 3/5&#xD;
Reference: rehabmeasures.org</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)</title>
        <description>Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Enrolled Subjects Who Completed the Study</title>
            <description>All subjects in the study used the Indego</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)</title>
          <description>Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study</title>
        <description>Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.</description>
        <time_frame>4 weeks, 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Enrolled Subjects Who Completed the Study</title>
            <description>All subjects in the study used the Indego</description>
          </group>
        </group_list>
        <measure>
          <title>Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study</title>
          <description>Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.</description>
          <units>meters/second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average speed for 10MWT mid study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average speed for 10MWT end of study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Timed Up and Go (TUG) Test</title>
        <description>Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Enrolled Subjects Who Completed the Study</title>
            <description>All subjects in the study used the Indego</description>
          </group>
        </group_list>
        <measure>
          <title>Timed Up and Go (TUG) Test</title>
          <description>Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.09" spread="20.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Time to Don/Doff Device</title>
        <description>Time needed for an individual to don or doff the device.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Enrolled Subjects Who Completed the Study</title>
            <description>All subjects in the study used the Indego</description>
          </group>
        </group_list>
        <measure>
          <title>Average Time to Don/Doff Device</title>
          <description>Time needed for an individual to don or doff the device.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average time to don device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average time to doff device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects That Could Don/Doff the Device Independently</title>
        <description>The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Enrolled Subjects Who Completed the Study</title>
            <description>All subjects in the study used the Indego</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects That Could Don/Doff the Device Independently</title>
          <description>The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.</description>
          <units>percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects that could don device independently</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects that could doff device independently</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Walking Index for Spinal Cord Injury (WISCI-II) Assessment</title>
        <description>Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.&#xD;
0:unable&#xD;
parallel bars, braces, help of 2 persons,&lt;10m&#xD;
parallel bars, braces, help of 2 persons,10m&#xD;
parallel bars, braces, help of 1 person,10m&#xD;
parallel bars, no braces, help of 1 person,10m&#xD;
parallel bars, braces, no help,10m&#xD;
walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m&#xD;
8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m&#xD;
Reference: rehabmeasures.org</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Enrolled Subjects Who Completed the Study</title>
            <description>All subjects in the study used the Indego</description>
          </group>
        </group_list>
        <measure>
          <title>Walking Index for Spinal Cord Injury (WISCI-II) Assessment</title>
          <description>Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.&#xD;
0:unable&#xD;
parallel bars, braces, help of 2 persons,&lt;10m&#xD;
parallel bars, braces, help of 2 persons,10m&#xD;
parallel bars, braces, help of 1 person,10m&#xD;
parallel bars, no braces, help of 1 person,10m&#xD;
parallel bars, braces, no help,10m&#xD;
walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m&#xD;
8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m&#xD;
Reference: rehabmeasures.org</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Independence Measure (FIM) Score for Walking Indoors</title>
        <description>FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.&#xD;
7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance&#xD;
1: total assistance&#xD;
Reference: rehabmeasures.org</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Enrolled Subjects Who Completed the Study</title>
            <description>All subjects in the study used the Indego</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Independence Measure (FIM) Score for Walking Indoors</title>
          <description>FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.&#xD;
7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance&#xD;
1: total assistance&#xD;
Reference: rehabmeasures.org</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Borg Rating of Perceived Exertion (BRPE) for Walking Indoors</title>
        <description>The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.&#xD;
6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Enrolled Subjects Who Completed the Study</title>
            <description>All subjects in the study used the Indego</description>
          </group>
        </group_list>
        <measure>
          <title>Borg Rating of Perceived Exertion (BRPE) for Walking Indoors</title>
          <description>The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.&#xD;
6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Subjects</title>
          <description>All subjects enrolled in the study used the Indego</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bruise</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Scrape/Cut/Abrasion</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Skin Redness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Ryan Farris</name_or_title>
      <organization>Parker Hannifin Corporation</organization>
      <phone>(216) 896-3335</phone>
      <email>ryan.farris@parker.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/NCT02202538
org study id: PH-IND01
nct id: NCT02202538
lead sponsor: 
has dmc: Yes
This study will evaluate the Indego® device for safety and effectiveness at allowing persons
      with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of
      conditions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)
time frame: 8 weeks
description: Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.
measure: Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study
time frame: 4 weeks, 8 weeks
description: Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.
measure: Timed Up and Go (TUG) Test
time frame: 8 weeks
description: Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.
measure: Average Time to Don/Doff Device
time frame: 8 weeks
description: Time needed for an individual to don or doff the device.
measure: Percentage of Subjects That Could Don/Doff the Device Independently
time frame: 8 weeks
description: The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.
measure: Walking Index for Spinal Cord Injury (WISCI-II) Assessment
time frame: 8 weeks
description: Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.
0:unable
parallel bars, braces, help of 2 persons,<10m
parallel bars, braces, help of 2 persons,10m
parallel bars, braces, help of 1 person,10m
parallel bars, no braces, help of 1 person,10m
parallel bars, braces, no help,10m
walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m
8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m
Reference: rehabmeasures.org
measure: Functional Independence Measure (FIM) Score for Walking Indoors
time frame: 8 weeks
description: FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.
7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance
1: total assistance
Reference: rehabmeasures.org
measure: Borg Rating of Perceived Exertion (BRPE) for Walking Indoors
time frame: 8 weeks
description: The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.
6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion
arm group label: Indego
arm group type: Experimental
description: Indego
intervention type: Device
intervention name: Indego
description: Indego
arm group label: Indego
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 