<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/NCT03011099</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-13-0536</org_study_id>
    <nct_id>NCT03011099</nct_id>
  </id_info>
  <brief_title>Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons</brief_title>
  <official_title>Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether robotic exoskeleton training can improve&#xD;
      walking performance after SCI as compared to conventional physical therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>The 10 Meter Walk Test assesses the time taken to walk 10 meters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Walking Endurance as Assessed by the 6 Minute Walk Test</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>The 6 Minute Walk Test assesses the distance walked in 6 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Muscle Activity as Assessed by Surface Electromyography (EMG)</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Energy Expenditure During Walking as Assessed by Oxygen Cost</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)</measure>
    <time_frame>baseline, week 4</time_frame>
    <description>The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range:&#xD;
0 = total paralysis&#xD;
= palpable or visible contraction&#xD;
= active movement, full range of motion (ROM) with gravity eliminated&#xD;
= active movement, full ROM against gravity&#xD;
= active movement, full ROM against gravity and moderate resistance in a muscle specific position&#xD;
= (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person&#xD;
We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exoskeleton User Feedback as Assessed by a Questionnaire</measure>
    <time_frame>week 4</time_frame>
    <description>A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Robotic exoskeleton training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Physical Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic exoskeleton training</intervention_name>
    <description>During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.</description>
    <arm_group_label>Robotic exoskeleton training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional physical therapy</intervention_name>
    <description>During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.</description>
    <arm_group_label>Conventional Physical Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Motor Incomplete spinal cord injury, as classified by American Spinal Injury&#xD;
             Association guidelines, above the lumbar level (T12 and above).&#xD;
&#xD;
          -  Able to independently stand for two minutes with or without an assistive device and&#xD;
             with or without orthoses distal to the knee.&#xD;
&#xD;
          -  Male or non-pregnant woman&#xD;
&#xD;
          -  ≥ 18-years of age&#xD;
&#xD;
          -  At least 6 months after injury&#xD;
&#xD;
          -  Height between 5'2&quot; and 6'2&quot; (150-188 cm)&#xD;
&#xD;
          -  Weight ≤ 220 pounds (100 kg)&#xD;
&#xD;
          -  Ability to perform informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of clinical signs of lower motor neuron injury&#xD;
&#xD;
          -  History of severe neurologic injuries other than SCI (MS, CP, ALS, TBI, CVA, etc.)&#xD;
&#xD;
          -  Severe comorbidities: active infections, heart, lung, or circulatory conditions,&#xD;
             pressure ulcers.&#xD;
&#xD;
          -  Documented severe osteoporosis affecting the hip and spine&#xD;
&#xD;
          -  Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled&#xD;
             clonus&#xD;
&#xD;
          -  Unstable spine&#xD;
&#xD;
          -  Unhealed limb or pelvic fractures&#xD;
&#xD;
          -  Skin issues that would prevent wearing the device&#xD;
&#xD;
          -  Range of motion restrictions that would prevent subject from achieving a normal,&#xD;
             reciprocal gait pattern, or would restrict a subject from completing normal sit to&#xD;
             stand or stand to sit transitions.&#xD;
&#xD;
          -  Upper extremity strength deficits that limit ability to balance with a front rolling&#xD;
             walker or crutches.&#xD;
&#xD;
          -  Heterotopic ossification that resists functional range of motion in lower extremities&#xD;
&#xD;
          -  Contractures (&gt;15 degrees at the hips or &gt;20 degrees at the knees)&#xD;
&#xD;
          -  Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity&#xD;
             concerns&#xD;
&#xD;
          -  Colostomy&#xD;
&#xD;
          -  Have received any physical therapy intervention within 3 months prior to enrolment in&#xD;
             the study&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Davis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <results_first_submitted>April 22, 2017</results_first_submitted>
  <results_first_submitted_qc>March 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">April 3, 2018</results_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Matthew Edward Davis</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>
      <pre_assignment_details>One participant dropped out of the study after signing the consent before randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Robotic Exoskeleton Training</title>
          <description>During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.</description>
        </group>
        <group group_id="P2">
          <title>Conventional Physical Therapy</title>
          <description>During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Robotic Exoskeleton Training</title>
          <description>During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.</description>
        </group>
        <group group_id="B2">
          <title>Conventional Physical Therapy</title>
          <description>During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.</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="6"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </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="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test</title>
        <description>The 10 Meter Walk Test assesses the time taken to walk 10 meters.</description>
        <time_frame>baseline, week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test</title>
          <description>The 10 Meter Walk Test assesses the time taken to walk 10 meters.</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="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.815" spread="9.58"/>
                    <measurement group_id="O2" value="-0.5" spread="4.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Walking Endurance as Assessed by the 6 Minute Walk Test</title>
        <description>The 6 Minute Walk Test assesses the distance walked in 6 minutes.</description>
        <time_frame>baseline, week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Walking Endurance as Assessed by the 6 Minute Walk Test</title>
          <description>The 6 Minute Walk Test assesses the distance walked in 6 minutes.</description>
          <units>feet</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.3833" spread="42.83"/>
                    <measurement group_id="O2" value="25.3" spread="25.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test</title>
        <description>The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.</description>
        <time_frame>baseline, week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test</title>
          <description>The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.</description>
          <units>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="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.575" spread="17.31"/>
                    <measurement group_id="O2" value="-1.59" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Muscle Activity as Assessed by Surface Electromyography (EMG)</title>
        <description>Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.</description>
        <time_frame>baseline, week 4</time_frame>
        <population>This measure was later added to the protocol and hence data was collected from one participant only.</population>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Muscle Activity as Assessed by Surface Electromyography (EMG)</title>
          <description>Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.</description>
          <population>This measure was later added to the protocol and hence data was collected from one participant only.</population>
          <units>percentage of muscle activity change</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change in soleus activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in gastrocnemius activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in tibialis anterior activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Rectus Femoris activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Vastus Medialis activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Bicep Femoris activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Semitendinosus activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Energy Expenditure During Walking as Assessed by Oxygen Cost</title>
        <description>Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).</description>
        <time_frame>baseline, week 4</time_frame>
        <population>The metabolic expenditure was only measured for two subjects who completed the Robotic exoskeleton training at the end of the study. The equipment to use metabolic expenditure was not available at that time of enrollment of the population at the beginning of the study. Therefore data was only collected once the equipment became operational.</population>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Energy Expenditure During Walking as Assessed by Oxygen Cost</title>
          <description>Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).</description>
          <population>The metabolic expenditure was only measured for two subjects who completed the Robotic exoskeleton training at the end of the study. The equipment to use metabolic expenditure was not available at that time of enrollment of the population at the beginning of the study. Therefore data was only collected once the equipment became operational.</population>
          <units>ml/min/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.84" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)</title>
        <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.</description>
        <time_frame>baseline, week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)</title>
          <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.</description>
          <units>steps/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.17"/>
                    <measurement group_id="O2" value="0.08" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)</title>
        <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.</description>
        <time_frame>baseline, week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)</title>
          <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.11"/>
                    <measurement group_id="O2" value="-0.03" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)</title>
        <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).</description>
        <time_frame>baseline, week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)</title>
          <description>Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).</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="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.13"/>
                    <measurement group_id="O2" value="-0.02" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)</title>
        <description>The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range:&#xD;
0 = total paralysis&#xD;
= palpable or visible contraction&#xD;
= active movement, full range of motion (ROM) with gravity eliminated&#xD;
= active movement, full ROM against gravity&#xD;
= active movement, full ROM against gravity and moderate resistance in a muscle specific position&#xD;
= (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person&#xD;
We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.</description>
        <time_frame>baseline, week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)</title>
          <description>The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range:&#xD;
0 = total paralysis&#xD;
= palpable or visible contraction&#xD;
= active movement, full range of motion (ROM) with gravity eliminated&#xD;
= active movement, full ROM against gravity&#xD;
= active movement, full ROM against gravity and moderate resistance in a muscle specific position&#xD;
= (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person&#xD;
We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.</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="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="2.15"/>
                    <measurement group_id="O2" value="-0.17" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exoskeleton User Feedback as Assessed by a Questionnaire</title>
        <description>A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.</description>
        <time_frame>week 4</time_frame>
        <population>This measure was only recorded from the participants in the robotic exoskeleton training group. This outcome was mainly related to the feedback of the participants after using the exoskeleton at the end of the training.</population>
        <group_list>
          <group group_id="O1">
            <title>Robotic Exoskeleton Training</title>
            <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
          </group>
          <group group_id="O2">
            <title>Conventional Physical Therapy</title>
            <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</description>
          </group>
        </group_list>
        <measure>
          <title>Exoskeleton User Feedback as Assessed by a Questionnaire</title>
          <description>A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.</description>
          <population>This measure was only recorded from the participants in the robotic exoskeleton training group. This outcome was mainly related to the feedback of the participants after using the exoskeleton at the end of the training.</population>
          <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="6"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.83" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected for each participant during their participation in the study. the study protocol was 1 month long.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Robotic Exoskeleton Training</title>
          <description>Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes</description>
        </group>
        <group group_id="E2">
          <title>Conventional Physical Therapy</title>
          <description>Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training</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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </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="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>swelling and pain in foot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </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>Chang, Shuo-Hsiu, PT, PhD</name_or_title>
      <organization>UT health PM&amp;R</organization>
      <phone>713-799-7016</phone>
      <email>Shuo-Hsiu.Chang@uth.tmc.edu</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/NCT03011099
org study id: HSC-MS-13-0536
nct id: NCT03011099
lead sponsor: 
has dmc: No
The purpose of this study is to investigate whether robotic exoskeleton training can improve
      walking performance after SCI as compared to conventional physical therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
time frame: baseline, week 4
description: The 10 Meter Walk Test assesses the time taken to walk 10 meters.
measure: Change in Walking Endurance as Assessed by the 6 Minute Walk Test
time frame: baseline, week 4
description: The 6 Minute Walk Test assesses the distance walked in 6 minutes.
measure: Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test
time frame: baseline, week 4
description: The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.
measure: Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
time frame: baseline, week 4
description: Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.
measure: Change in Energy Expenditure During Walking as Assessed by Oxygen Cost
time frame: baseline, week 4
description: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).
measure: Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)
time frame: baseline, week 4
description: Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.
measure: Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)
time frame: baseline, week 4
description: Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.
measure: Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)
time frame: baseline, week 4
description: Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).
measure: Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
time frame: baseline, week 4
description: The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range:
0 = total paralysis
= palpable or visible contraction
= active movement, full range of motion (ROM) with gravity eliminated
= active movement, full ROM against gravity
= active movement, full ROM against gravity and moderate resistance in a muscle specific position
= (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person
We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.
measure: Exoskeleton User Feedback as Assessed by a Questionnaire
time frame: week 4
description: A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.
arm group label: Robotic exoskeleton training
arm group type: Experimental
description: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
arm group label: Conventional Physical Therapy
arm group type: Active Comparator
description: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
intervention type: Device
intervention name: Robotic exoskeleton training
description: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
arm group label: Robotic exoskeleton training
intervention type: Other
intervention name: Conventional physical therapy
description: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
arm group label: Conventional Physical Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Davis, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Matthew Edward Davis
investigator title: Assistant Professor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 