<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/NCT03287739</url>
  </required_header>
  <id_info>
    <org_study_id>2017-00889</org_study_id>
    <nct_id>NCT03287739</nct_id>
  </id_info>
  <brief_title>Recovery of Impairments Early After Stroke</brief_title>
  <acronym>aRISE</acronym>
  <official_title>Recovery of Impairments Early After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      Upper limb recovery after stroke is highly predictable early after stroke. Nijland et al.&#xD;
      showed that based on two simple clinical bedside tests - 'Shoulder Abduction' and 'Finger&#xD;
      Extension' (the so called 'SAFE model' [Stinear et al., 2012]) - measured within the first 72&#xD;
      hours after stroke, ~87% of the patients could be correctly classified as either regaining or&#xD;
      not regaining some dexterity (recoverers or nonrecoverers, respectively) (Nijland et al.,&#xD;
      2010). This kind of information regarding the patients' functional prognosis allows proper&#xD;
      discharge planning, setting realistic rehabilitation goals, and adequate patient information.&#xD;
      However, the length of hospital stay after stroke has been decreasing. Therefore, knowledge&#xD;
      is needed regarding the ability to make an accurate first prediction within the first 24&#xD;
      hours after stroke onset while using simple clinical bedside assessments. This would&#xD;
      facilitate an earlier triage and with that, an accelerated and smooth transition of patients&#xD;
      within the stroke care continuum. In addition, a first prediction within 24 hours poststroke&#xD;
      has the potential to decrease health care expenses, as length of hospital stay after an acute&#xD;
      stroke is ~30% of the total costs (i.e., direct and indirect costs) associated with stroke&#xD;
      (Roger et al., 2012; Fattore et al., 2012).&#xD;
&#xD;
      The primary objective of aRISE is to determine the ability of the behavioral biometric&#xD;
      impairments 'Shoulder Abduction' and 'Finger Extension' measured &lt;24 hours poststroke to&#xD;
      predict outcome of upper limb capacity 3 months after stroke. The secondary aim is to&#xD;
      investigate the the added value of other simple clinical bedside tests for predicting outcome&#xD;
      of upper limb capacity 3 months poststroke.&#xD;
&#xD;
      aRISE is a prospective longitudinal observational cohort study of 40 first-ever ischemic&#xD;
      stroke patients, who will be assessed &lt;24 hours, 7 days and 3 months after stroke onset.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 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>Action Research Arm Test</measure>
    <time_frame>3 months poststroke</time_frame>
    <description>Upper limb capacity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>3 months poststroke</time_frame>
    <description>Upper limb motor function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motricity Index</measure>
    <time_frame>3 months poststroke</time_frame>
    <description>Upper limb motor function</description>
  </primary_outcome>
  <other_outcome>
    <measure>Surface Electromyography</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Forearm skeletal muscle electric activity</description>
  </other_outcome>
  <other_outcome>
    <measure>Movement Sensors</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Upper limb range of motion patterns</description>
  </other_outcome>
  <other_outcome>
    <measure>National Institutes of Health Stroke Scale</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Neurological functions</description>
  </other_outcome>
  <other_outcome>
    <measure>Trunk Control Test</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Sitting balance</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional Ambulation Categories</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Walking ability (independence)</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Global disability</description>
  </other_outcome>
  <other_outcome>
    <measure>Motor Activity Log - 14</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Patient-reported daily life upper limb use</description>
  </other_outcome>
  <other_outcome>
    <measure>Global Rating of Perceived Changes</measure>
    <time_frame>3 months poststroke</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Concomitant Movement Therapy</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Intensity of therapy based on charts</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety</measure>
    <time_frame>48 hours, 7 days, and 3 months poststroke</time_frame>
    <description>Serious Events (1. death; 2. life-threatening illness or injury; 3. in-patient or prolonged hospitalisation; 4. medical or surgical intervention to prevent life threatening illness; 5. led to fetal distress, death or a congenital abnormality or birth defect)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Single-group study</arm_group_label>
    <description>Assessment of behavioral biometric impairments</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assessment of behavioral biometric impairments</intervention_name>
    <description>Assessment of behavioral biometric impairments</description>
    <arm_group_label>Single-group study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        First-ever unilateral ischemic stroke patients, admitted to hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-ever unilateral ischemic stroke in the middle cerebral artery territory &lt;48&#xD;
             hours, confirmed by MRI-DWI and/or CT&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Able to follow one-staged commands&#xD;
&#xD;
          -  NIHSS arm score ≥1&#xD;
&#xD;
          -  Informed consent after participants' information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Modified Rankin Scale score &gt;2 before stroke&#xD;
&#xD;
          -  Neurological or other diseases affecting the upper limb(s) before stroke&#xD;
&#xD;
          -  Intravenous line in the upper limb(s) which limits assessment&#xD;
&#xD;
          -  Contra-indications on ethical grounds&#xD;
&#xD;
          -  Expected or known non-compliance to participate in the observational study, severe&#xD;
             drug or/and alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Fattore G, Torbica A, Susi A, Giovanni A, Benelli G, Gozzo M, Toso V. The social and economic burden of stroke survivors in Italy: a prospective, incidence-based, multi-centre cost of illness study. BMC Neurol. 2012 Nov 14;12:137. doi: 10.1186/1471-2377-12-137.</citation>
    <PMID>23150894</PMID>
  </reference>
  <reference>
    <citation>Nijland RH, van Wegen EE, Harmeling-van der Wel BC, Kwakkel G; EPOS Investigators. Presence of finger extension and shoulder abduction within 72 hours after stroke predicts functional recovery: early prediction of functional outcome after stroke: the EPOS cohort study. Stroke. 2010 Apr;41(4):745-50. doi: 10.1161/STROKEAHA.109.572065. Epub 2010 Feb 18.</citation>
    <PMID>20167916</PMID>
  </reference>
  <reference>
    <citation>Stinear CM, Barber PA, Petoe M, Anwar S, Byblow WD. The PREP algorithm predicts potential for upper limb recovery after stroke. Brain. 2012 Aug;135(Pt 8):2527-35. doi: 10.1093/brain/aws146. Epub 2012 Jun 10.</citation>
    <PMID>22689909</PMID>
  </reference>
  <reference>
    <citation>Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.</citation>
    <PMID>22179539</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_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 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Upper Extremity</keyword>
  <keyword>Cohort Studies</keyword>
  <keyword>Prognosis</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>
  <!-- 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/NCT03287739
org study id: 2017-00889
nct id: NCT03287739
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Upper limb recovery after stroke is highly predictable early after stroke. Nijland et al.
      showed that based on two simple clinical bedside tests - 'Shoulder Abduction' and 'Finger
      Extension' (the so called 'SAFE model' [Stinear et al., 2012]) - measured within the first 72
      hours after stroke, ~87% of the patients could be correctly classified as either regaining or
      not regaining some dexterity (recoverers or nonrecoverers, respectively) (Nijland et al.,
      2010). This kind of information regarding the patients' functional prognosis allows proper
      discharge planning, setting realistic rehabilitation goals, and adequate patient information.
      However, the length of hospital stay after stroke has been decreasing. Therefore, knowledge
      is needed regarding the ability to make an accurate first prediction within the first 24
      hours after stroke onset while using simple clinical bedside assessments. This would
      facilitate an earlier triage and with that, an accelerated and smooth transition of patients
      within the stroke care continuum. In addition, a first prediction within 24 hours poststroke
      has the potential to decrease health care expenses, as length of hospital stay after an acute
      stroke is ~30% of the total costs (i.e., direct and indirect costs) associated with stroke
      (Roger et al., 2012; Fattore et al., 2012).

      The primary objective of aRISE is to determine the ability of the behavioral biometric
      impairments 'Shoulder Abduction' and 'Finger Extension' measured <24 hours poststroke to
      predict outcome of upper limb capacity 3 months after stroke. The secondary aim is to
      investigate the the added value of other simple clinical bedside tests for predicting outcome
      of upper limb capacity 3 months poststroke.

      aRISE is a prospective longitudinal observational cohort study of 40 first-ever ischemic
      stroke patients, who will be assessed <24 hours, 7 days and 3 months after stroke onset.
observational model: Cohort
time perspective: Prospective
measure: Action Research Arm Test
time frame: 3 months poststroke
description: Upper limb capacity
measure: Fugl-Meyer Assessment
time frame: 3 months poststroke
description: Upper limb motor function
measure: Motricity Index
time frame: 3 months poststroke
description: Upper limb motor function
measure: Surface Electromyography
time frame: 48 hours, 7 days, and 3 months poststroke
description: Forearm skeletal muscle electric activity
measure: Movement Sensors
time frame: 48 hours, 7 days, and 3 months poststroke
description: Upper limb range of motion patterns
measure: National Institutes of Health Stroke Scale
time frame: 48 hours, 7 days, and 3 months poststroke
description: Neurological functions
measure: Trunk Control Test
time frame: 48 hours, 7 days, and 3 months poststroke
description: Sitting balance
measure: Functional Ambulation Categories
time frame: 48 hours, 7 days, and 3 months poststroke
description: Walking ability (independence)
measure: Modified Rankin Scale
time frame: 48 hours, 7 days, and 3 months poststroke
description: Global disability
measure: Motor Activity Log - 14
time frame: 48 hours, 7 days, and 3 months poststroke
description: Patient-reported daily life upper limb use
measure: Global Rating of Perceived Changes
time frame: 3 months poststroke
measure: Concomitant Movement Therapy
time frame: 48 hours, 7 days, and 3 months poststroke
description: Intensity of therapy based on charts
measure: Safety
time frame: 48 hours, 7 days, and 3 months poststroke
description: Serious Events (1. death; 2. life-threatening illness or injury; 3. in-patient or prolonged hospitalisation; 4. medical or surgical intervention to prevent life threatening illness; 5. led to fetal distress, death or a congenital abnormality or birth defect)
arm group label: Single-group study
description: Assessment of behavioral biometric impairments
intervention type: Behavioral
intervention name: Assessment of behavioral biometric impairments
description: Assessment of behavioral biometric impairments
arm group label: Single-group study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
citation: Fattore G, Torbica A, Susi A, Giovanni A, Benelli G, Gozzo M, Toso V. The social and economic burden of stroke survivors in Italy: a prospective, incidence-based, multi-centre cost of illness study. BMC Neurol. 2012 Nov 14;12:137. doi: 10.1186/1471-2377-12-137.
PMID: 23150894
citation: Nijland RH, van Wegen EE, Harmeling-van der Wel BC, Kwakkel G; EPOS Investigators. Presence of finger extension and shoulder abduction within 72 hours after stroke predicts functional recovery: early prediction of functional outcome after stroke: the EPOS cohort study. Stroke. 2010 Apr;41(4):745-50. doi: 10.1161/STROKEAHA.109.572065. Epub 2010 Feb 18.
PMID: 20167916
citation: Stinear CM, Barber PA, Petoe M, Anwar S, Byblow WD. The PREP algorithm predicts potential for upper limb recovery after stroke. Brain. 2012 Aug;135(Pt 8):2527-35. doi: 10.1093/brain/aws146. Epub 2012 Jun 10.
PMID: 22689909
citation: Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.
PMID: 22179539
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No