<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/NCT03023150</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00027450</org_study_id>
    <nct_id>NCT03023150</nct_id>
  </id_info>
  <brief_title>Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert</brief_title>
  <official_title>Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marquette University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be the first study to use ischemic preconditioning (IPC) as an intervention&#xD;
      to improve stroke rehabilitation. IPC is a well studied, well tolerated intervention which&#xD;
      has been shown to improve regional blood flow, motor neuron excitability and muscle function&#xD;
      in multiple patient groups and in young, healthy subjects. Because IPC targets three&#xD;
      physiological systems which are all affected by stroke, we hypothesize that repeated bouts of&#xD;
      IPC during the first days to months following stroke (when the majority of recovery occurs)&#xD;
      will make traditional rehabilitation strategies more effective.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">August 2023</completion_date>
  <primary_completion_date type="Actual">August 2023</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Knee Extensor Strength</measure>
    <time_frame>Admission into study and within 3 days of Discharge from Froedtert Hospital</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Walking Speed</measure>
    <time_frame>Admission into study and within 3 days of Discharge from Froedtert Hospital</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Stroke Rehabilitation</condition>
  <condition>Ischemic Preconditioning</condition>
  <condition>Physical and Rehabilitation Medicine</condition>
  <arm_group>
    <arm_group_label>Ischemic Preconditioning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ischemic Preconditioning</intervention_name>
    <arm_group_label>Ischemic Preconditioning</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham</intervention_name>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. be between the ages of 40-80&#xD;
&#xD;
          2. able to give informed consent.&#xD;
&#xD;
          3. be &lt; 6 months post diagnosis of unilateral cortical stroke and&#xD;
&#xD;
          4. have residual leg paresis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. chronic low back or hip pain&#xD;
&#xD;
          2. substance abuse&#xD;
&#xD;
          3. head trauma with loss of conciousness in last 6 months&#xD;
&#xD;
          4. neurodegenerative disorder&#xD;
&#xD;
          5. participant taking any medication or supplement that adversely interacts with&#xD;
             nitroglycerin (exclusion from nitro administration only, applies to outpatients only)&#xD;
&#xD;
          6. participant has a known allergy to nitroglycerin (exclusion from nitro administration&#xD;
             only, applies to outpatients only)&#xD;
&#xD;
          7. resting systolic blood pressure &lt; 90mmHg (exclusion from nitro administration only,&#xD;
             applies to outpatients only)&#xD;
&#xD;
          8. any condition where knee extension contractions are contraindicated&#xD;
&#xD;
          9. people who are unable to follow multi step commands.&#xD;
&#xD;
         10. pregnancy (DXA scan exclusion only)&#xD;
&#xD;
         11. history of major psychiatric disorder&#xD;
&#xD;
         12. participant has had a myocardial infarction in the last year&#xD;
&#xD;
         13. participant has stage II hypertension (BP&gt;160/100)&#xD;
&#xD;
         14. participant is unable to contract knee muscles&#xD;
&#xD;
         15. participant is unable to sit upright for 2 hours&#xD;
&#xD;
         16. participant has a resting heart rate &gt;100 beats per minute&#xD;
&#xD;
         17. history of multiple strokes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Matthew J. Durand</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>Stroke</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03023150
org study id: PRO00027450
nct id: NCT03023150
lead sponsor: 
collaborator: 
has dmc: No
This study will be the first study to use ischemic preconditioning (IPC) as an intervention
      to improve stroke rehabilitation. IPC is a well studied, well tolerated intervention which
      has been shown to improve regional blood flow, motor neuron excitability and muscle function
      in multiple patient groups and in young, healthy subjects. Because IPC targets three
      physiological systems which are all affected by stroke, we hypothesize that repeated bouts of
      IPC during the first days to months following stroke (when the majority of recovery occurs)
      will make traditional rehabilitation strategies more effective.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Knee Extensor Strength
time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital
measure: Change in Walking Speed
time frame: Admission into study and within 3 days of Discharge from Froedtert Hospital
arm group label: Ischemic Preconditioning
arm group type: Experimental
description: Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
arm group label: Sham
arm group type: Sham Comparator
description: Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
intervention type: Other
intervention name: Ischemic Preconditioning
arm group label: Ischemic Preconditioning
intervention type: Other
intervention name: Sham
arm group label: Sham
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Matthew J. Durand
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Ischemia
sharing ipd: Undecided