<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/NCT03305731</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17070071</org_study_id>
    <nct_id>NCT03305731</nct_id>
  </id_info>
  <brief_title>Activating Behavior for Lasting Engagement After Stroke</brief_title>
  <acronym>ABLE</acronym>
  <official_title>Activating Behavior for Lasting Engagement After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</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>
      Stroke survivors demonstrate high levels of sedentary behavior, placing them at risk for&#xD;
      exacerbation of chronic health conditions. This may lead to recurrent stroke. Subtle&#xD;
      cognitive impairments are common after stroke and can lead to difficulty self-monitoring and&#xD;
      problem solving to overcome barriers to physical activity. Investigators developed the&#xD;
      Activating Behavior for Lasting Engagement (ABLE) intervention to promote activity&#xD;
      scheduling, self-monitoring, and problem solving activity over the full day. This study&#xD;
      examines the effects of the ABLE intervention on sedentary behavior after stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study advisory committee added a dose-matched, no-intervention delayed baseline to the&#xD;
      study protocol following initial documentation of this study protocol on clinicaltrials.gov.&#xD;
      The purpose of this delayed baseline design was to assess the baseline stability on the&#xD;
      primary and secondary outcomes. The addition of this timepoint resulted in a shift of&#xD;
      post-intervention timepoints as follows: Baseline 1 (week 1), Baseline 2 (week 6),&#xD;
      Post-intervention (week 11), and Follow-up (week 18). Intervention was delivered between&#xD;
      Baseline 2 and Post-intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">January 4, 2019</completion_date>
  <primary_completion_date type="Actual">January 4, 2019</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>Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes</measure>
    <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks</time_frame>
    <description>Objectively measured sedentary time (ActivPAL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Daily Number of Sedentary Breaks</measure>
    <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks</time_frame>
    <description>Objectively measured sedentary breaks (ActivPAL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Daily Number of Sedentary Breaks</measure>
    <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks</time_frame>
    <description>Objectively measured sedentary breaks (ActivPAL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes</measure>
    <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks</time_frame>
    <description>Objectively measured sedentary time (ActivPAL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Participation</measure>
    <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks</time_frame>
    <description>Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale&#xD;
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Participation</measure>
    <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks</time_frame>
    <description>Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale&#xD;
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Stroke</condition>
  <condition>Physical Activity</condition>
  <condition>Sedentary Lifestyle</condition>
  <condition>Behavior, Health</condition>
  <condition>Physical Disability</condition>
  <arm_group>
    <arm_group_label>Activating Behavior for Lasting Engagement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will engage in the ABLE intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Activating Behavior for Lasting Engagement</intervention_name>
    <description>Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
    <arm_group_label>Activating Behavior for Lasting Engagement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosis of ischemic or hemorrhagic stroke&#xD;
&#xD;
          2. ≥6 months and ≤24 months post-stroke&#xD;
&#xD;
          3. ≥18 years of age&#xD;
&#xD;
          4. ambulatory in the community with or without an assistive device (e.g. walker, cane)&#xD;
&#xD;
          5. self-reported sedentary behavior (≥6 hours/day of sedentary behavior reported using&#xD;
             the Sedentary Behavior Questionnaire)&#xD;
&#xD;
          6. reside within 50 miles of Pittsburgh, Pennsylvania&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. severe aphasia (Boston Diagnostic Aphasia Examination score ≤1)&#xD;
&#xD;
          2. currently receiving outpatient or home care rehabilitation services (physical therapy,&#xD;
             occupational therapy, or speech therapy)&#xD;
&#xD;
          3. current active cancer treatment&#xD;
&#xD;
          4. medical history of neurodegenerative disorder (i.e. dementia, Parkinson's disease,&#xD;
             multiple sclerosis, Lou Gehrig's disease (ALS), glioblastoma, myasthenia gravis)&#xD;
&#xD;
          5. current major depressive disorder, psychiatric condition, substance abuse (Patient&#xD;
             Health Questionnaire-9, PRIME-MD/MINI)&#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>Emily A Kringle, MOT, OTR/L</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth R Skidmore, PhD, OTR/L</last_name>
    <role>Study Chair</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</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>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <results_first_submitted>January 15, 2020</results_first_submitted>
  <results_first_submitted_qc>February 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 19, 2020</results_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Emily Kringle</investigator_full_name>
    <investigator_title>Occupational Therapist</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Disability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03305731/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Activating Behavior for Lasting Engagement</title>
          <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 6</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 11</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</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>Activating Behavior for Lasting Engagement</title>
          <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.81" spread="10.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke Chronicity</title>
          <description>Months elapsed between date of stroke onset and date of baseline testing. Date of stroke onset was extracted from medical records.</description>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.38" spread="14.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Ischemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hemorrhagic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke Hemisphere</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Left Hemisphere</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Right Hemisphere</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Both Hemispheres</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prolonged Sitting</title>
          <description>Measured using ActivPAL micro3 (Pal Technologies, Glasgow) following 7-day wear protocol. The mean daily duration of prolonged sitting accumulated in bouts of greater than or equal to 30 minutes was computed.</description>
          <population>Non-compliance with activity monitor, n=1</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="466.56" spread="168.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes</title>
        <description>Objectively measured sedentary time (ActivPAL)</description>
        <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Activating Behavior for Lasting Engagement</title>
            <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes</title>
          <description>Objectively measured sedentary time (ActivPAL)</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.95" spread="81.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Daily Number of Sedentary Breaks</title>
        <description>Objectively measured sedentary breaks (ActivPAL)</description>
        <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Activating Behavior for Lasting Engagement</title>
            <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Daily Number of Sedentary Breaks</title>
          <description>Objectively measured sedentary breaks (ActivPAL)</description>
          <units>breaks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.61" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Daily Number of Sedentary Breaks</title>
        <description>Objectively measured sedentary breaks (ActivPAL)</description>
        <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Activating Behavior for Lasting Engagement</title>
            <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Daily Number of Sedentary Breaks</title>
          <description>Objectively measured sedentary breaks (ActivPAL)</description>
          <units>breaks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.55" spread="5.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes</title>
        <description>Objectively measured sedentary time (ActivPAL)</description>
        <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Activating Behavior for Lasting Engagement</title>
            <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes</title>
          <description>Objectively measured sedentary time (ActivPAL)</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.08" spread="58.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Participation</title>
        <description>Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale&#xD;
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.</description>
        <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Activating Behavior for Lasting Engagement</title>
            <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Participation</title>
          <description>Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale&#xD;
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.</description>
          <units>score 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.48" spread="8.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Participation</title>
        <description>Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale&#xD;
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.</description>
        <time_frame>Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Activating Behavior for Lasting Engagement</title>
            <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Participation</title>
          <description>Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale&#xD;
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.</description>
          <units>score 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" spread="15.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Activating Behavior for Lasting Engagement</title>
          <description>Participants will engage in the ABLE intervention.&#xD;
Activating Behavior for Lasting Engagement: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.</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="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </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>Dr. Emily Kringle</name_or_title>
      <organization>University of Illinois at Chicago</organization>
      <phone>312-996-9665</phone>
      <email>kringle@uic.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/NCT03305731
org study id: PRO17070071
nct id: NCT03305731
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke survivors demonstrate high levels of sedentary behavior, placing them at risk for
      exacerbation of chronic health conditions. This may lead to recurrent stroke. Subtle
      cognitive impairments are common after stroke and can lead to difficulty self-monitoring and
      problem solving to overcome barriers to physical activity. Investigators developed the
      Activating Behavior for Lasting Engagement (ABLE) intervention to promote activity
      scheduling, self-monitoring, and problem solving activity over the full day. This study
      examines the effects of the ABLE intervention on sedentary behavior after stroke.
The study advisory committee added a dose-matched, no-intervention delayed baseline to the
      study protocol following initial documentation of this study protocol on clinicaltrials.gov.
      The purpose of this delayed baseline design was to assess the baseline stability on the
      primary and secondary outcomes. The addition of this timepoint resulted in a shift of
      post-intervention timepoints as follows: Baseline 1 (week 1), Baseline 2 (week 6),
      Post-intervention (week 11), and Follow-up (week 18). Intervention was delivered between
      Baseline 2 and Post-intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
description: Objectively measured sedentary time (ActivPAL)
measure: Change in Daily Number of Sedentary Breaks
time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
description: Objectively measured sedentary breaks (ActivPAL)
measure: Change in Daily Number of Sedentary Breaks
time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
description: Objectively measured sedentary breaks (ActivPAL)
measure: Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
description: Objectively measured sedentary time (ActivPAL)
measure: Change in Participation
time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
description: Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.
measure: Change in Participation
time frame: Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks
description: Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale
The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation.
arm group label: Activating Behavior for Lasting Engagement
arm group type: Experimental
description: Participants will engage in the ABLE intervention.
intervention type: Behavioral
intervention name: Activating Behavior for Lasting Engagement
description: Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
arm group label: Activating Behavior for Lasting Engagement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emily A Kringle, MOT, OTR/L
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Elizabeth R Skidmore, PhD, OTR/L
role: Study Chair
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Emily Kringle
investigator title: Occupational Therapist
mesh term: Stroke
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 