<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/NCT03257111</url>
  </required_header>
  <id_info>
    <org_study_id>2016-104</org_study_id>
    <nct_id>NCT03257111</nct_id>
  </id_info>
  <brief_title>Activity Levels and Rehabilitation Outcomes of Patients Post-stroke</brief_title>
  <official_title>The Correlation Between Activity Levels and Rehabilitation Outcomes of Patients Post-stroke in an In-patient Rehabilitation Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida Gulf Coast University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brookdale Center for Healthy Aging &amp; Rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida Gulf Coast University</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>
      Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be&#xD;
      recruited into the study. The participants will wear two activity monitors (one commercial&#xD;
      grade and one research grade) for the duration of their rehab stay. Data from the monitors&#xD;
      will be correlated with rehab outcomes, therapy units billed, and length of stay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Actual">July 21, 2020</completion_date>
  <primary_completion_date type="Actual">July 21, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity Level</measure>
    <time_frame>from the date of recruitment to the date of discharge or up to 45 days whichever comes first</time_frame>
    <description>Amount of physical activity each day and throughout rehab stay as measured by 2 activity monitors beginning at admission and ending at discharge from the facility</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>therapy units billed</measure>
    <time_frame>from the date of recruitment to the date of discharge or up to 45 days whichever comes first</time_frame>
    <description>therapy units are billed 15 minute time blocks; the number of each type of unit will be assessed at discharge from the facility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM)</measure>
    <time_frame>from the date of recruitment to the date of discharge or up to 45 days whichever comes first</time_frame>
    <description>FIM is a standard rehabilitation outcome used in all rehabilitation hospitals; measured at admission and discharge from the facility</description>
  </secondary_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>activity monitors</intervention_name>
    <description>activity monitors are worn on the wrist, much like a watch. Data from the activity monitors will be downloaded once a week and at discharge. Normal hospital and therapy activities will not be altered.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include only people with a diagnosis of stroke who have been admitted to&#xD;
        the in-patient rehabilitation facility &quot;Brookdale Center for Healthy Aging &amp;&#xD;
        Rehabilitation&quot; in Naples, FL. The side of the stroke, the type of the stroke, or a history&#xD;
        of prior stroke are not considerations. The study is intended to be very clinically focused&#xD;
        to better understand the activity level of the population seen at the facility. This study&#xD;
        is purposely not controlling the population to a very narrow presentation so that the&#xD;
        results will speak directly to the facility and their outcomes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of stroke&#xD;
&#xD;
          -  patient at the Brookdale Center for Healthy Aging &amp; Rehabilitation&#xD;
&#xD;
          -  not greater than maximum assistance to walk 10 feet&#xD;
&#xD;
          -  walking re-training included in the therapy plan of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  primary diagnosis other than stroke&#xD;
&#xD;
          -  allergy or reaction to the wrist bands of the activity monitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mollie Venglar, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida Gulf Coast University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida Gulf Coast University</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33965</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brookdale Center for Healthy Aging &amp; Rehabilitation</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>April 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida Gulf Coast University</investigator_affiliation>
    <investigator_full_name>Sherry Alexander</investigator_full_name>
    <investigator_title>Research Compliance Coordinator</investigator_title>
  </responsible_party>
  <keyword>rehabilitation outcomes</keyword>
  <keyword>activity level</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>
    <ipd_description>IPD will not be shared outside of the research team</ipd_description>
  </patient_data>
  <!-- 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/NCT03257111
org study id: 2016-104
nct id: NCT03257111
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be
      recruited into the study. The participants will wear two activity monitors (one commercial
      grade and one research grade) for the duration of their rehab stay. Data from the monitors
      will be correlated with rehab outcomes, therapy units billed, and length of stay.
observational model: Cohort
time perspective: Prospective
measure: Physical Activity Level
time frame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
description: Amount of physical activity each day and throughout rehab stay as measured by 2 activity monitors beginning at admission and ending at discharge from the facility
measure: therapy units billed
time frame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
description: therapy units are billed 15 minute time blocks; the number of each type of unit will be assessed at discharge from the facility
measure: Functional Independence Measure (FIM)
time frame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
description: FIM is a standard rehabilitation outcome used in all rehabilitation hospitals; measured at admission and discharge from the facility
intervention type: Other
intervention name: activity monitors
description: activity monitors are worn on the wrist, much like a watch. Data from the activity monitors will be downloaded once a week and at discharge. Normal hospital and therapy activities will not be altered.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mollie Venglar, DSc
role: Principal Investigator
affiliation: Florida Gulf Coast University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida Gulf Coast University
investigator full name: Sherry Alexander
investigator title: Research Compliance Coordinator
mesh term: Stroke
sharing ipd: No
ipd description: IPD will not be shared outside of the research team