<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/NCT03261388</url>
  </required_header>
  <id_info>
    <org_study_id>CK-1604</org_study_id>
    <nct_id>NCT03261388</nct_id>
  </id_info>
  <brief_title>Activity Based Locomotor Exercise PrOgram-Wait-list controllEd Research</brief_title>
  <acronym>ABLE-POWER</acronym>
  <official_title>ABLE POWER - Activity Based Locomotor Exercise PrOgram: Wait-list controllEd Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allina Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allina Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      At Courage Kenny Rehabilitation Institute, rehabilitation for individuals with spinal cord&#xD;
      injury (SCI) is being led by the NIH funded NeuroRecovery Network (NRN) Community Fitness and&#xD;
      Wellness Program through the Activity-Based Locomotor Exercise Program (ABLE). Any individual&#xD;
      with a spinal cord injury who is eligible for the ABLE Program is eligible for participation&#xD;
      in the NeuroRecovery Network Research Project (NRN). The purpose of the ABLE POWER Study is&#xD;
      to evaluate the effectiveness of activity-based locomotor exercise programs in individuals&#xD;
      with SCI through a wait-list controlled design. Individuals who have a spinal cord injury and&#xD;
      are on the wait list for ABLE will be enrolled in this project for a year while they wait for&#xD;
      an opening in the ABLE program. Changes that occur while participants are on the wait list&#xD;
      will be compared to changes that occur after they are enrolled in ABLE. A difference in the&#xD;
      rate of improvement after enrollment in the intervention would be attributed to the ABLE&#xD;
      intervention. Individuals participating in the ABLE program will receive the ABLE&#xD;
      intervention regardless of participation in the ABLE POWER research study. In this design,&#xD;
      there will be two measures in the year prior to enrollment in ABLE, and two measures in the&#xD;
      year after enrollment, and the two time periods would be compared to the data collected at&#xD;
      enrollment into ABLE.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change in subject population/ABLE POWER program&#xD;
  </why_stopped>
  <start_date type="Actual">November 7, 2016</start_date>
  <completion_date type="Actual">January 21, 2020</completion_date>
  <primary_completion_date type="Actual">January 21, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Neuromuscular Recovery Scale (NRS)</measure>
    <time_frame>At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE</time_frame>
    <description>The NRS measures motor function in individuals with SCI without allowing compensatory motions. This 15 item measure is collected while the participants are on the mat, in sitting, standing, and on the weight supported treadmill. Items include upper extremity function, lower extremity function, sitting, sit to stand, standing, and locomotor items.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE</time_frame>
    <description>The COPM is a client-centered measure of performance and satisfaction using client identified meaningful activities and has been used with individuals who have SCI as a means to identify personally meaningful goals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Craig Handicap Assessment and Reporting Technique (CHART)</measure>
    <time_frame>At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE</time_frame>
    <description>The Craig Handicap Assessment and Reporting Technique (CHART) is a measure of social participation in individuals with SCI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in American Spinal Injury Association Impairment Scale (AIS)</measure>
    <time_frame>At entry to wait list, at enrollment to the ABLE program (6-13 months after entry to wait list), 12 months post entry to ABLE</time_frame>
    <description>The American Spinal Injury Association Impairment Scale (AIS) classifies the motor and sensory impairment that results from a SCI, and is the gold standard for identifying completeness of a SCI.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>ABLE POWER Program</arm_group_label>
    <description>Participants on the Activity-Based Locomotor Exercise Program (ABLE) waitlist will be enrolled prior to beginning the ABLE program. This waiting period will allow outcomes to be compared (in the same participant) before receiving the intervention and after receiving the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Activity-Based Locomotor Exercise Program (ABLE)</intervention_name>
    <description>The ABLE program is an intensive locomotor based intervention that is offered at the Golden Valley Courage Kenny Rehabilitation Institute.</description>
    <arm_group_label>ABLE POWER Program</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants for this research study will be recruited from adults with spinal cord injury&#xD;
        (SCI) on the wait list for the Neurorecovery Network (NRN) research study. These&#xD;
        individuals have injuries at all spinal levels and categories of completeness.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participant must be eligible for the Neurorecovery Network (NRN) Study.&#xD;
             Eligibility criteria for the NRN study are as follows: The participant must have a&#xD;
             spinal cord injury, at any spinal level or time since injury. Individuals with&#xD;
             uncontrolled diabetes, uncontrolled seizures, uncontrolled autonomic dysreflexia,&#xD;
             uncontrolled hypotension, unstable angina, history of heart attack, osteoporosis, or&#xD;
             weight of more than 275 pounds (due to the weight limit of the partial weight&#xD;
             supported treadmill system) are not eligible.&#xD;
&#xD;
          -  The participant must be on the ABLE wait list.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • The participant must NOT have previously participated in ABLE.&#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>Nancy Flinn, PhD, OTR/L</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allina Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Courage Kenny Rehabilitation Institute</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Allina Health System</investigator_affiliation>
    <investigator_full_name>Nancy Flinn</investigator_full_name>
    <investigator_title>Senior Scientific Advisor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03261388
org study id: CK-1604
nct id: NCT03261388
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
At Courage Kenny Rehabilitation Institute, rehabilitation for individuals with spinal cord
      injury (SCI) is being led by the NIH funded NeuroRecovery Network (NRN) Community Fitness and
      Wellness Program through the Activity-Based Locomotor Exercise Program (ABLE). Any individual
      with a spinal cord injury who is eligible for the ABLE Program is eligible for participation
      in the NeuroRecovery Network Research Project (NRN). The purpose of the ABLE POWER Study is
      to evaluate the effectiveness of activity-based locomotor exercise programs in individuals
      with SCI through a wait-list controlled design. Individuals who have a spinal cord injury and
      are on the wait list for ABLE will be enrolled in this project for a year while they wait for
      an opening in the ABLE program. Changes that occur while participants are on the wait list
      will be compared to changes that occur after they are enrolled in ABLE. A difference in the
      rate of improvement after enrollment in the intervention would be attributed to the ABLE
      intervention. Individuals participating in the ABLE program will receive the ABLE
      intervention regardless of participation in the ABLE POWER research study. In this design,
      there will be two measures in the year prior to enrollment in ABLE, and two measures in the
      year after enrollment, and the two time periods would be compared to the data collected at
      enrollment into ABLE.
observational model: Other
time perspective: Prospective
measure: Change in Neuromuscular Recovery Scale (NRS)
time frame: At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE
description: The NRS measures motor function in individuals with SCI without allowing compensatory motions. This 15 item measure is collected while the participants are on the mat, in sitting, standing, and on the weight supported treadmill. Items include upper extremity function, lower extremity function, sitting, sit to stand, standing, and locomotor items.
measure: Change in Canadian Occupational Performance Measure (COPM)
time frame: At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE
description: The COPM is a client-centered measure of performance and satisfaction using client identified meaningful activities and has been used with individuals who have SCI as a means to identify personally meaningful goals
measure: Change in Craig Handicap Assessment and Reporting Technique (CHART)
time frame: At entry to wait list, after 6 months, at enrollment to the ABLE program (6-13 months after entry to wait list), 6 months post entry to ABLE, 12 months post entry to ABLE
description: The Craig Handicap Assessment and Reporting Technique (CHART) is a measure of social participation in individuals with SCI.
measure: Change in American Spinal Injury Association Impairment Scale (AIS)
time frame: At entry to wait list, at enrollment to the ABLE program (6-13 months after entry to wait list), 12 months post entry to ABLE
description: The American Spinal Injury Association Impairment Scale (AIS) classifies the motor and sensory impairment that results from a SCI, and is the gold standard for identifying completeness of a SCI.
arm group label: ABLE POWER Program
description: Participants on the Activity-Based Locomotor Exercise Program (ABLE) waitlist will be enrolled prior to beginning the ABLE program. This waiting period will allow outcomes to be compared (in the same participant) before receiving the intervention and after receiving the intervention.
intervention type: Behavioral
intervention name: Activity-Based Locomotor Exercise Program (ABLE)
description: The ABLE program is an intensive locomotor based intervention that is offered at the Golden Valley Courage Kenny Rehabilitation Institute.
arm group label: ABLE POWER Program
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nancy Flinn, PhD, OTR/L
role: Principal Investigator
affiliation: Allina Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Allina Health System
investigator full name: Nancy Flinn
investigator title: Senior Scientific Advisor
mesh term: Spinal Cord Injuries