<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/NCT02235974</url>
  </required_header>
  <id_info>
    <org_study_id>MNRH-2014-065</org_study_id>
    <nct_id>NCT02235974</nct_id>
  </id_info>
  <brief_title>Critical Periods After Stroke Study (CPASS)</brief_title>
  <acronym>CPASS</acronym>
  <official_title>Critical Periods After Stroke Study (CPASS); Sensitive Periods and Consumer Preferences: Optimizing Upper Extremity Stroke Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedStar National Rehabilitation Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Catholic University of America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MedStar National Rehabilitation Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To perform an exploratory single center randomized study that will form the basis for a&#xD;
      larger scale, more definitive randomized clinical trial to determine the optimal time after&#xD;
      stroke for intensive motor training. The investigators will perform a prospective exploratory&#xD;
      study of upper extremity (UE) motor training delivered at higher than usual intensity at&#xD;
      three different time points after stroke:&#xD;
&#xD;
        -  early (initiated within 30 days)&#xD;
&#xD;
        -  subacute/outpatient (initiated within 2-3 months)&#xD;
&#xD;
        -  chronic (initiated within 6-9 months)&#xD;
&#xD;
      The control group will not receive the therapy intervention during the 1-year study.&#xD;
&#xD;
      Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and&#xD;
      one year after stroke onset.&#xD;
&#xD;
      Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or&#xD;
      chronic (6-9 months after stroke onset) time points, participants randomized to early&#xD;
      intensive motor training will show greater upper extremity motor improvement measured at one&#xD;
      year post stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Please see the following reference:&#xD;
&#xD;
      Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan,&#xD;
      E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M.,&#xD;
      Fiandaca, M.S., Federoff, H.J., &amp; Newport, E.L. (2015). Critical Periods after Stroke Study:&#xD;
      Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human&#xD;
      Neuroscience, 9, 002231. PMCID: PMC4413691.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 26, 2014</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Action Research Arm Test (ARAT)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log - 28 Quality of Movement (MAL-28 QOM)</measure>
    <time_frame>Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>A structured interview to measure upper extremity use and function as well as assess the quality of movement of the hemiparetic arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nine Hole Peg Test (9-HPT)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>A standardized quantitative test of upper extremity function and fine manual dexterity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>A basic indicator of severity of disability. Tracks changes in the functional ability of the patient during an episode of hospital rehabilitation care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index (BI)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>Measures performance in activities of daily living and functional disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motricity Index - Arm only (MI)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>To assess motor impairment and strength in the upper extremity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of change (POC)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke</time_frame>
    <description>A stroke-specific self-report to assess how stroke has impacted a person's life and their overall perception of recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale - Hand-Arm subscale (SIS)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke</time_frame>
    <description>A self-report health status measure to assess perceived recovery with regard to the more affected hand and arm following a stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale (MRS)</measure>
    <time_frame>Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke</time_frame>
    <description>A measure of the degree of disability or dependence in daily activities following a stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Card Sort (ACS)</measure>
    <time_frame>Pre-treatment (ideally within 72 hours of baseline), post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reintegration to Normal Living Index (RNLI)</measure>
    <time_frame>Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>To assess quantitatively the degree that individuals who have experienced a traumatic injury or illness come to manage and reintegrate normal social activities with regard to recreation, movement at home and within the community, family and relationships.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale (GDS-15)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke</time_frame>
    <description>A self-report assessment used to identify depressive symptoms in the elderly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIH Stroke Scale (NIHSS)</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke</time_frame>
    <description>A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Blessed Orientation and Memory Concentration Test (SBT)</measure>
    <time_frame>Baseline (within 30 days post stroke)</time_frame>
    <description>An assessment of cognitive ability and impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mesulam Symbol Cancellation Test (SCT)</measure>
    <time_frame>Baseline (within 30 days post stroke)</time_frame>
    <description>An assessment used to evaluate visuospatial function and attention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faces Pain Scale</measure>
    <time_frame>Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke</time_frame>
    <description>A self-report measure of pain intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl Meyer Assessment (Upper Extremity)</measure>
    <time_frame>Baseline (within 30 days post stroke) and 1 year post stroke</time_frame>
    <description>A performanced-based impairment index to assess motor function, sensation and joint function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Muscle Test (Upper Extremity)</measure>
    <time_frame>Baseline (within 30 days post stroke)</time_frame>
    <description>Muscle strength assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Motor Assessment Scale - Upper Arm Function (MAS)</measure>
    <time_frame>Baseline (within 30 days of stroke onset)</time_frame>
    <description>Performance-based scale to assess everyday motor function.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Stroke</condition>
  <condition>Brain Infarction</condition>
  <condition>Brain Ischemia</condition>
  <condition>Cerebral Infarction</condition>
  <condition>Cerebrovascular Disorders</condition>
  <arm_group>
    <arm_group_label>Acute/Early</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-acute/Outpatient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Early Intensive upper extremity motor training</intervention_name>
    <description>Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset.</description>
    <arm_group_label>Acute/Early</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sub-acute intensive upper extremity motor training</intervention_name>
    <description>Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke.</description>
    <arm_group_label>Sub-acute/Outpatient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Chronic intensive upper extremity motor training</intervention_name>
    <description>Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke.</description>
    <arm_group_label>Chronic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Usual and Customary Care only. No additional therapy will be given during the 1-year study.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of&#xD;
             admission to inpatient rehabilitation (allows those randomized to the early arm to&#xD;
             begin study-related treatment within 30 days)&#xD;
&#xD;
          -  Age &gt;21 years&#xD;
&#xD;
          -  Able to participate in first study-related treatment session within 30 days of stroke&#xD;
             onset&#xD;
&#xD;
          -  Able to participate in all study-related activities, including one year follow up and&#xD;
             blood draws&#xD;
&#xD;
          -  Persistent hemiparesis leading to impaired upper extremity function. Hemiparesis as&#xD;
             indicated by NIHSS Motor Arm score ≥ 1&#xD;
&#xD;
          -  Recovering moderate motor impairment at the shoulder and elbow or hand such as:&#xD;
&#xD;
               -  Proximal UE voluntary activity indicated by a score of ≥ 3 on the upper arm item&#xD;
                  of the Motor Assessment Scale - wrist and finger movement is not required&#xD;
&#xD;
        or&#xD;
&#xD;
          -  Manual Muscle Test (MMT) score of ≥ 2 on shoulder flexion or abduction and MMT score&#xD;
             of ≥ 2 for any of the following: elbow flexion, elbow extension, wrist flexion, wrist&#xD;
             extension, finger flexion or finger extension.&#xD;
&#xD;
        or&#xD;
&#xD;
          -  Active range of motion (AROM) to at least 50% of range in gravity eliminated position&#xD;
             for shoulder flexion or abduction, and for any of the following motions: elbow&#xD;
             flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger&#xD;
             extension.&#xD;
&#xD;
               -  Score of ≤ 8 on the Short Blessed Memory Orientation and Concentration Scale&#xD;
&#xD;
               -  Follows 2 step commands&#xD;
&#xD;
               -  No upper extremity injury or conditions that limited use prior to the stroke&#xD;
&#xD;
               -  Pre-stroke independence: Modified Rankin Score 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Prior stroke with persistent motor impairment or other disabling neurologic condition&#xD;
             such as multiple sclerosis, parkinsonism, amyotrophic lateral sclerosis (ALS),&#xD;
             dementia requiring medication&#xD;
&#xD;
          -  Rapidly improving motor function&#xD;
&#xD;
          -  Clinically significant fluctuations in mental status in the 72 hours prior to&#xD;
             randomization&#xD;
&#xD;
          -  Hemispatial neglect as determined by &gt;3 errors on the Mesulam Symbol Cancellation Test&#xD;
&#xD;
          -  Not independent prior to stroke (determined by scores of &lt;95 on Barthel Index or &gt;1 on&#xD;
             Modified Rankin Scale&#xD;
&#xD;
          -  Dense sensory loss indicated by a score of 2 on NIHSS sensory item&#xD;
&#xD;
          -  Ataxia out of proportion to weakness in the affected arm as described by a score of ≥&#xD;
             1 on the NIHSS limb ataxia item&#xD;
&#xD;
          -  Active or prior psychosis within 2 years&#xD;
&#xD;
          -  Active or prior (within 2 years) substance abuse&#xD;
&#xD;
          -  Not expected to survive 1 year due to other illnesses (cardiac disease, malignancy,&#xD;
             etc)&#xD;
&#xD;
          -  Received upper extremity botulinum toxin within 6 months (other medications do not&#xD;
             exclude)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander W Dromerick, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MedStar National Rehabilitation Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedStar National Rehabilitation Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dromerick AW, Edwardson MA, Edwards DF, Giannetti ML, Barth J, Brady KP, Chan E, Tan MT, Tamboli I, Chia R, Orquiza M, Padilla RM, Cheema AK, Mapstone ME, Fiandaca MS, Federoff HJ, Newport EL. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial. Front Hum Neurosci. 2015 Apr 29;9:231. doi: 10.3389/fnhum.2015.00231. eCollection 2015.</citation>
    <PMID>25972803</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MedStar National Rehabilitation Network</investigator_affiliation>
    <investigator_full_name>Alexander W. Dromerick, MD</investigator_full_name>
    <investigator_title>Vice President for Research</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>critical periods</keyword>
  <keyword>sensitive periods</keyword>
  <keyword>hemiparesis</keyword>
  <keyword>upper extremity</keyword>
  <keyword>physical rehabilitation</keyword>
  <keyword>arm therapy</keyword>
  <keyword>occupational therapy</keyword>
  <keyword>physical therapy</keyword>
  <keyword>task oriented training</keyword>
  <keyword>patient focused</keyword>
  <keyword>arm function</keyword>
  <keyword>hand function</keyword>
  <keyword>neurorehabilitation</keyword>
  <keyword>motor learning</keyword>
  <keyword>motor control</keyword>
  <keyword>motor function</keyword>
  <keyword>motor recovery</keyword>
  <keyword>skill acquisition</keyword>
  <keyword>skill training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Brain Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan at this time to make individual participant data available.</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/NCT02235974
org study id: MNRH-2014-065
nct id: NCT02235974
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
To perform an exploratory single center randomized study that will form the basis for a
      larger scale, more definitive randomized clinical trial to determine the optimal time after
      stroke for intensive motor training. The investigators will perform a prospective exploratory
      study of upper extremity (UE) motor training delivered at higher than usual intensity at
      three different time points after stroke:

        -  early (initiated within 30 days)

        -  subacute/outpatient (initiated within 2-3 months)

        -  chronic (initiated within 6-9 months)

      The control group will not receive the therapy intervention during the 1-year study.

      Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and
      one year after stroke onset.

      Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or
      chronic (6-9 months after stroke onset) time points, participants randomized to early
      intensive motor training will show greater upper extremity motor improvement measured at one
      year post stroke.
Please see the following reference:

      Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan,
      E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M.,
      Fiandaca, M.S., Federoff, H.J., & Newport, E.L. (2015). Critical Periods after Stroke Study:
      Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human
      Neuroscience, 9, 002231. PMCID: PMC4413691.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Action Research Arm Test (ARAT)
time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.
measure: Motor Activity Log - 28 Quality of Movement (MAL-28 QOM)
time frame: Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: A structured interview to measure upper extremity use and function as well as assess the quality of movement of the hemiparetic arm.
measure: Nine Hole Peg Test (9-HPT)
time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: A standardized quantitative test of upper extremity function and fine manual dexterity.
measure: Functional Independence Measure (FIM)
time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: A basic indicator of severity of disability. Tracks changes in the functional ability of the patient during an episode of hospital rehabilitation care.
measure: Barthel Index (BI)
time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: Measures performance in activities of daily living and functional disability.
measure: Motricity Index - Arm only (MI)
time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: To assess motor impairment and strength in the upper extremity.
measure: Perception of change (POC)
time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
description: A stroke-specific self-report to assess how stroke has impacted a person's life and their overall perception of recovery.
measure: Stroke Impact Scale - Hand-Arm subscale (SIS)
time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
description: A self-report health status measure to assess perceived recovery with regard to the more affected hand and arm following a stroke.
measure: Modified Rankin Scale (MRS)
time frame: Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
description: A measure of the degree of disability or dependence in daily activities following a stroke.
measure: Activity Card Sort (ACS)
time frame: Pre-treatment (ideally within 72 hours of baseline), post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities.
measure: Reintegration to Normal Living Index (RNLI)
time frame: Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: To assess quantitatively the degree that individuals who have experienced a traumatic injury or illness come to manage and reintegrate normal social activities with regard to recreation, movement at home and within the community, family and relationships.
measure: Geriatric Depression Scale (GDS-15)
time frame: Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke
description: A self-report assessment used to identify depressive symptoms in the elderly.
measure: NIH Stroke Scale (NIHSS)
time frame: Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke
description: A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity.
measure: Short Blessed Orientation and Memory Concentration Test (SBT)
time frame: Baseline (within 30 days post stroke)
description: An assessment of cognitive ability and impairment.
measure: Mesulam Symbol Cancellation Test (SCT)
time frame: Baseline (within 30 days post stroke)
description: An assessment used to evaluate visuospatial function and attention.
measure: Faces Pain Scale
time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
description: A self-report measure of pain intensity.
measure: Fugl Meyer Assessment (Upper Extremity)
time frame: Baseline (within 30 days post stroke) and 1 year post stroke
description: A performanced-based impairment index to assess motor function, sensation and joint function.
measure: Manual Muscle Test (Upper Extremity)
time frame: Baseline (within 30 days post stroke)
description: Muscle strength assessment
measure: Motor Assessment Scale - Upper Arm Function (MAS)
time frame: Baseline (within 30 days of stroke onset)
description: Performance-based scale to assess everyday motor function.
arm group label: Acute/Early
arm group type: Experimental
description: Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke.
arm group label: Sub-acute/Outpatient
arm group type: Experimental
description: Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke.
arm group label: Chronic
arm group type: Experimental
description: Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke
arm group label: Control
arm group type: Placebo Comparator
description: Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.
intervention type: Behavioral
intervention name: Early Intensive upper extremity motor training
description: Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset.
arm group label: Acute/Early
intervention type: Behavioral
intervention name: Sub-acute intensive upper extremity motor training
description: Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke.
arm group label: Sub-acute/Outpatient
intervention type: Behavioral
intervention name: Chronic intensive upper extremity motor training
description: Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke.
arm group label: Chronic
intervention type: Behavioral
intervention name: Control
description: Usual and Customary Care only. No additional therapy will be given during the 1-year study.
arm group label: Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander W Dromerick, MD
role: Principal Investigator
affiliation: MedStar National Rehabilitation Network
facility: 
country: United States
citation: Dromerick AW, Edwardson MA, Edwards DF, Giannetti ML, Barth J, Brady KP, Chan E, Tan MT, Tamboli I, Chia R, Orquiza M, Padilla RM, Cheema AK, Mapstone ME, Fiandaca MS, Federoff HJ, Newport EL. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial. Front Hum Neurosci. 2015 Apr 29;9:231. doi: 10.3389/fnhum.2015.00231. eCollection 2015.
PMID: 25972803
responsible party type: Principal Investigator
investigator affiliation: MedStar National Rehabilitation Network
investigator full name: Alexander W. Dromerick, MD
investigator title: Vice President for Research
mesh term: Stroke
mesh term: Cerebral Infarction
mesh term: Cerebrovascular Disorders
mesh term: Brain Ischemia
mesh term: Brain Infarction
mesh term: Infarction
mesh term: Ischemia
sharing ipd: No
ipd description: There is no plan at this time to make individual participant data available.