xml: <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/NCT05978596</url>
    </required_header>
    <id_info>
      <org_study_id>CvdW</org_study_id>
      <nct_id>NCT05978596</nct_id>
    </id_info>
    <brief_title>Time Course of a Misperception of Verticality and Its Characteristics in Post-stroke Participants</brief_title>
    <official_title>Postural Alignment in Post-stroke Participants: Providing New Insights in the Time Course of a Misperception of Verticality and Its Characteristics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universiteit Antwerpen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universiteit Antwerpen</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Little is known about the time course of verticality perception after stroke. This study aims&#xD;
        to assess:&#xD;
  &#xD;
          -  The time course of verticality perception (Subjective Visual, Haptic and Postural&#xD;
             Vertical; resp., SVV, SHV, SPV);&#xD;
  &#xD;
          -  The longitudinal interaction of the recovery of spatial disorders (e.g., different types&#xD;
             of neglect, lateropulsion) with verticality perception;&#xD;
  &#xD;
          -  The longitudinal interaction of motor function and outcomes (such as paresis, sitting&#xD;
             balance and standing balance) and verticality perception.&#xD;
  &#xD;
        The participants will be repetitively assessed during the subacute phase post-stroke, to&#xD;
        evaluate the time course of:&#xD;
  &#xD;
          -  The SVV, SHV and SPV;&#xD;
  &#xD;
          -  Spatial disorders (visuospatial and personal neglect, lateropulsion)&#xD;
  &#xD;
          -  Motor function (lower limb strength, sitting and standing balance, functionality in ADL,&#xD;
             trunk performance)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For a correct vertical alignment of the body with the gravitational vector, the patient must&#xD;
        be able to accurately perceive verticality. Estimation of verticality is a complex process,&#xD;
        suggested to be based on internal references derived from the integration of multisensory&#xD;
        input (e.g. visual, vestibular and somatosensory). Due to a brain lesion, this complex&#xD;
        process can be hampered, resulting in a deviation of the subjective vertical.&#xD;
  &#xD;
        Different modalities of verticality perception can be assessed, including the Subjective&#xD;
        Visual (SVV), Haptic (SHV) and Postural (SPV) Vertical. Previous studies reported a deviation&#xD;
        of the subjective vertical in post-stroke patients. These deviations are associated with&#xD;
        poorer balance performance. However, some stroke participants have more difficulties with&#xD;
        accurately estimating a vertical position as compared to others. This increased magnitude is&#xD;
        often seen in participants with lateropulsion or spatial neglect.&#xD;
  &#xD;
        Although previous studies showed an increased deviation of the subjective vertical in&#xD;
        post-stroke patients, little is known about the recovery of this misperception of&#xD;
        verticality. Especially in patients with spatial disorders (e.g., lateropulsion or (different&#xD;
        subtypes of) neglect), there is clear lack of studies assessing the longitudinal recovery of&#xD;
        a misperception of verticality. Knowledge about the spontaneous recovery of a deviated&#xD;
        verticality perception and its association with spatial disorders, will give insights in the&#xD;
        role of a misperception of verticality in these disorders.&#xD;
  &#xD;
        Although disturbances in perceiving verticality and decreased balance performance seems to be&#xD;
        related, it is unclear how these disturbances exactly impacts balance and functional outcome.&#xD;
        A longitudinal interaction between verticality perception and motor function will be&#xD;
        evaluated.&#xD;
  &#xD;
        Participants will be recruited from rehabilitation hospital Revarte (Edegem) or AZ Monica&#xD;
        (Antwerp). Participants will be included at 3 or 5 weeks post-stroke and evaluation will take&#xD;
        place at 3, 5, 8 and 12 weeks post-stroke. Also, in healthy participants the SVV, SHV and SPV&#xD;
        will be evaluated to obtain normative data.&#xD;
  &#xD;
        The outcome measures contain:&#xD;
  &#xD;
          -  Perception of verticality: SVV, SHV, SPV;&#xD;
  &#xD;
          -  Combination of pen-and-paper tasks and computerized tests to asses visuospatial and&#xD;
             personal neglect;&#xD;
  &#xD;
          -  Clinical scales to evaluate lateropulsion;&#xD;
  &#xD;
          -  Clinical scales to evaluate motor function (lower limb strength, sitting balance,&#xD;
             standing balance, functionality in ADL, trunk performance);&#xD;
  &#xD;
          -  Instrumented analysis to assess sitting and standing balance.&#xD;
  &#xD;
        For the data-analysis Linear Mixed Models will be used, to evaluate study results and mean&#xD;
        change over time.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2021</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Change in Subjective Visual Vertical constant error</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Visual Vertical constant error</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Visual Vertical constant error</measure>
      <time_frame>Change from 8 to 12</time_frame>
      <description>Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Hapic Vertical constant error</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Hapic Vertical constant error</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Hapic Vertical constant error</measure>
      <time_frame>Change from 8 to 12 weeks</time_frame>
      <description>Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical constant error</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical constant error</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical constant error</measure>
      <time_frame>Change from 8 to 12 weeks</time_frame>
      <description>Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Visual Vertical unsigned error</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Visual Vertical unsigned error</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Visual Vertical unsigned error</measure>
      <time_frame>Change from 8 to 12 weeks</time_frame>
      <description>Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Haptic Vertical unsigned error</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Haptic Vertical unsigned error</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Haptic Vertical unsigned error</measure>
      <time_frame>Change from 8 to 12 weeks</time_frame>
      <description>Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical unsigned error</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical unsigned error</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical unsigned error</measure>
      <time_frame>Change from 8 to 12 weeks</time_frame>
      <description>Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Visual Vertical variability</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Visual Vertical variability</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Visual Vertical variability</measure>
      <time_frame>Change from 8 to 12 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Haptic Vertical variability</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Haptic Vertical variability</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Haptic Vertical variability</measure>
      <time_frame>Change from 8 to 12 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical variability</measure>
      <time_frame>Change from 3 to 5 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical variability</measure>
      <time_frame>Change from 5 to 8 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Subjective Postural Vertical variability</measure>
      <time_frame>Change from 8 to 12 weeks</time_frame>
      <description>Reflects the intra-individual variability (standard deviation of the trials)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Trunk Control Test - item quiet siting for 30 seconds</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Sitting, hands on lap, feet of the ground. Score from 0 to 2. Higher score means better performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Berg Balance Scale - item quiet standing for 2 minutes</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Ability to stand unsupported. Score from 0 to 4. Higher score means better performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motricity index - lower limbs</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Strength of the hip flexors, knee extensors and dorsiflexors (paretic vs non paretic limb)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Line Bisection Test</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Visuospatial neglect test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visuospatial Search Time Test</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Visuospatial neglect test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fluff test</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Personal neglect test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tactile extinction test</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Personal neglect test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Burke Lateropulsion Scale</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Lateropulsion test. Score from 0-17.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scale for Contraversive Pushing</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Lateropulsion test. Score 0-6.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trunk Impairment test (dynamic and coordination subscales)</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Test to evaluate the dynamic and coordinative performance of the trunk</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight bearing asymmetry (standing)</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Difference in weight bearing (paretic vs non-paretic) in percentage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Broken Heart Test</measure>
      <time_frame>3, 5, 8, 12 weeks post-stroke</time_frame>
      <description>Change in cancellation task for visuospatial neglect</description>
    </secondary_outcome>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Stroke</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Participants will be recruited from rehabiliation hospital RevArte (Edegem) and AZ Monica&#xD;
          (Antwerp).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic supratentorial stroke;&#xD;
  &#xD;
            -  Able to give written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Bilateral lesions;&#xD;
  &#xD;
            -  Vestibular dysfunction, symptomatic orthostatic hypotension or other pre-existing&#xD;
               neurological conditions that could interfere with the assessments;&#xD;
  &#xD;
            -  Inability to understand and follow basic verbal instructions;&#xD;
  &#xD;
            -  Hemianopsia or other visual field deficits (glasses or corrective lenses are allowed)&#xD;
  &#xD;
          And a group of healthy controls to obtain normative data. These participants are eligible&#xD;
          for inclusion if they are between 18 and 90 years old and do not suffer from vestibular&#xD;
          dysfunction, symptomatic orthostatic hypotension or other neurological conditions that&#xD;
          could interfere with the assessment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wim Saeys, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universiteit Antwerpen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Charlotte van der Waal, MSc</last_name>
      <phone>+3232659724</phone>
      <email>charlotte.vanderwaal@uantwerpen.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wim Saeys, Prof. Dr.</last_name>
      <email>wim.saeys@uantwerpen.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>AZ Monica</name>
        <address>
          <city>Antwerp</city>
          <zip>2018</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Charlotte van der Waal</last_name>
        <email>charlotte.vanderwaal@uantwerpen.be</email>
      </contact>
      <contact_backup>
        <last_name>Jelena Warmenbol</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>RevArte</name>
        <address>
          <city>Edegem</city>
          <zip>2650</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Charlotte van der Waal, MSc</last_name>
        <email>charlotte.vanderwaal@uantwerpen.be</email>
      </contact>
      <contact_backup>
        <last_name>Wim Saeys, Dr</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <reference>
      <citation>van der Waal C, Embrechts E, Loureiro-Chaves R, Gebruers N, Truijen S, Saeys W. Lateropulsion with active pushing in stroke patients: its link with lesion location and the perception of verticality. A systematic review. Top Stroke Rehabil. 2023 Apr;30(3):281-297. doi: 10.1080/10749357.2022.2026563. Epub 2022 Feb 1.</citation>
      <PMID>35102816</PMID>
    </reference>
    <reference>
      <citation>Embrechts E, van der Waal C, Anseeuw D, van Buijnderen J, Leroij A, Lafosse C, Nijboer TC, Truijen S, Saeys W. Association between spatial neglect and impaired verticality perception after stroke: A systematic review. Ann Phys Rehabil Med. 2023 Apr;66(3):101700. doi: 10.1016/j.rehab.2022.101700. Epub 2022 Dec 1.</citation>
      <PMID>35963568</PMID>
    </reference>
    <reference>
      <citation>Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.</citation>
      <PMID>18678565</PMID>
    </reference>
    <reference>
      <citation>Bonan IV, Leman MC, Legargasson JF, Guichard JP, Yelnik AP. Evolution of subjective visual vertical perturbation after stroke. Neurorehabil Neural Repair. 2006 Dec;20(4):484-91. doi: 10.1177/1545968306289295.</citation>
      <PMID>17082504</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
      <investigator_full_name>Wim Saeys</investigator_full_name>
      <investigator_title>Professor Dr. Wim Saeys</investigator_title>
    </responsible_party>
    <keyword>Perception of verticality</keyword>
    <keyword>Spatial neglect</keyword>
    <keyword>Lateropulsion</keyword>
    <keyword>Postural control</keyword>
    <keyword>Subjective Visual Vertical</keyword>
    <keyword>Subjective Haptic Vertical</keyword>
    <keyword>Subjective Postural Vertical</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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978596
  org study id: CvdW
  nct id: NCT05978596
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Little is known about the time course of verticality perception after stroke. This study aims
        to assess:
  
          -  The time course of verticality perception (Subjective Visual, Haptic and Postural
             Vertical; resp., SVV, SHV, SPV);
  
          -  The longitudinal interaction of the recovery of spatial disorders (e.g., different types
             of neglect, lateropulsion) with verticality perception;
  
          -  The longitudinal interaction of motor function and outcomes (such as paresis, sitting
             balance and standing balance) and verticality perception.
  
        The participants will be repetitively assessed during the subacute phase post-stroke, to
        evaluate the time course of:
  
          -  The SVV, SHV and SPV;
  
          -  Spatial disorders (visuospatial and personal neglect, lateropulsion)
  
          -  Motor function (lower limb strength, sitting and standing balance, functionality in ADL,
             trunk performance)
  For a correct vertical alignment of the body with the gravitational vector, the patient must
        be able to accurately perceive verticality. Estimation of verticality is a complex process,
        suggested to be based on internal references derived from the integration of multisensory
        input (e.g. visual, vestibular and somatosensory). Due to a brain lesion, this complex
        process can be hampered, resulting in a deviation of the subjective vertical.
  
        Different modalities of verticality perception can be assessed, including the Subjective
        Visual (SVV), Haptic (SHV) and Postural (SPV) Vertical. Previous studies reported a deviation
        of the subjective vertical in post-stroke patients. These deviations are associated with
        poorer balance performance. However, some stroke participants have more difficulties with
        accurately estimating a vertical position as compared to others. This increased magnitude is
        often seen in participants with lateropulsion or spatial neglect.
  
        Although previous studies showed an increased deviation of the subjective vertical in
        post-stroke patients, little is known about the recovery of this misperception of
        verticality. Especially in patients with spatial disorders (e.g., lateropulsion or (different
        subtypes of) neglect), there is clear lack of studies assessing the longitudinal recovery of
        a misperception of verticality. Knowledge about the spontaneous recovery of a deviated
        verticality perception and its association with spatial disorders, will give insights in the
        role of a misperception of verticality in these disorders.
  
        Although disturbances in perceiving verticality and decreased balance performance seems to be
        related, it is unclear how these disturbances exactly impacts balance and functional outcome.
        A longitudinal interaction between verticality perception and motor function will be
        evaluated.
  
        Participants will be recruited from rehabilitation hospital Revarte (Edegem) or AZ Monica
        (Antwerp). Participants will be included at 3 or 5 weeks post-stroke and evaluation will take
        place at 3, 5, 8 and 12 weeks post-stroke. Also, in healthy participants the SVV, SHV and SPV
        will be evaluated to obtain normative data.
  
        The outcome measures contain:
  
          -  Perception of verticality: SVV, SHV, SPV;
  
          -  Combination of pen-and-paper tasks and computerized tests to asses visuospatial and
             personal neglect;
  
          -  Clinical scales to evaluate lateropulsion;
  
          -  Clinical scales to evaluate motor function (lower limb strength, sitting balance,
             standing balance, functionality in ADL, trunk performance);
  
          -  Instrumented analysis to assess sitting and standing balance.
  
        For the data-analysis Linear Mixed Models will be used, to evaluate study results and mean
        change over time.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in Subjective Visual Vertical constant error
  time frame: Change from 3 to 5 weeks
  description: Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Visual Vertical constant error
  time frame: Change from 5 to 8 weeks
  description: Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Visual Vertical constant error
  time frame: Change from 8 to 12
  description: Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Hapic Vertical constant error
  time frame: Change from 3 to 5 weeks
  description: Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Hapic Vertical constant error
  time frame: Change from 5 to 8 weeks
  description: Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Hapic Vertical constant error
  time frame: Change from 8 to 12 weeks
  description: Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Postural Vertical constant error
  time frame: Change from 3 to 5 weeks
  description: Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Postural Vertical constant error
  time frame: Change from 5 to 8 weeks
  description: Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Postural Vertical constant error
  time frame: Change from 8 to 12 weeks
  description: Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.
  measure: Change in Subjective Visual Vertical unsigned error
  time frame: Change from 3 to 5 weeks
  description: Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Visual Vertical unsigned error
  time frame: Change from 5 to 8 weeks
  description: Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Visual Vertical unsigned error
  time frame: Change from 8 to 12 weeks
  description: Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Haptic Vertical unsigned error
  time frame: Change from 3 to 5 weeks
  description: Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Haptic Vertical unsigned error
  time frame: Change from 5 to 8 weeks
  description: Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Haptic Vertical unsigned error
  time frame: Change from 8 to 12 weeks
  description: Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Postural Vertical unsigned error
  time frame: Change from 3 to 5 weeks
  description: Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Postural Vertical unsigned error
  time frame: Change from 5 to 8 weeks
  description: Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Postural Vertical unsigned error
  time frame: Change from 8 to 12 weeks
  description: Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.
  measure: Change in Subjective Visual Vertical variability
  time frame: Change from 3 to 5 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Change in Subjective Visual Vertical variability
  time frame: Change from 5 to 8 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Change in Subjective Visual Vertical variability
  time frame: Change from 8 to 12 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Change in Subjective Haptic Vertical variability
  time frame: Change from 3 to 5 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Change in Subjective Haptic Vertical variability
  time frame: Change from 5 to 8 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Change in Subjective Haptic Vertical variability
  time frame: Change from 8 to 12 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Change in Subjective Postural Vertical variability
  time frame: Change from 3 to 5 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Change in Subjective Postural Vertical variability
  time frame: Change from 5 to 8 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Change in Subjective Postural Vertical variability
  time frame: Change from 8 to 12 weeks
  description: Reflects the intra-individual variability (standard deviation of the trials)
  measure: Trunk Control Test - item quiet siting for 30 seconds
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Sitting, hands on lap, feet of the ground. Score from 0 to 2. Higher score means better performance.
  measure: Berg Balance Scale - item quiet standing for 2 minutes
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Ability to stand unsupported. Score from 0 to 4. Higher score means better performance.
  measure: Motricity index - lower limbs
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Strength of the hip flexors, knee extensors and dorsiflexors (paretic vs non paretic limb)
  measure: Line Bisection Test
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Visuospatial neglect test
  measure: Visuospatial Search Time Test
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Visuospatial neglect test
  measure: Fluff test
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Personal neglect test
  measure: Tactile extinction test
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Personal neglect test
  measure: Burke Lateropulsion Scale
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Lateropulsion test. Score from 0-17.
  measure: Scale for Contraversive Pushing
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Lateropulsion test. Score 0-6.
  measure: Trunk Impairment test (dynamic and coordination subscales)
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Test to evaluate the dynamic and coordinative performance of the trunk
  measure: Weight bearing asymmetry (standing)
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Difference in weight bearing (paretic vs non-paretic) in percentage
  measure: Broken Heart Test
  time frame: 3, 5, 8, 12 weeks post-stroke
  description: Change in cancellation task for visuospatial neglect
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wim Saeys, Prof. Dr.
  role: Principal Investigator
  affiliation: Universiteit Antwerpen
  last name: Charlotte van der Waal, MSc
  phone: +3232659724
  email: charlotte.vanderwaal@uantwerpen.be
  last name: Wim Saeys, Prof. Dr.
  email: wim.saeys@uantwerpen.be
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Belgium
  citation: van der Waal C, Embrechts E, Loureiro-Chaves R, Gebruers N, Truijen S, Saeys W. Lateropulsion with active pushing in stroke patients: its link with lesion location and the perception of verticality. A systematic review. Top Stroke Rehabil. 2023 Apr;30(3):281-297. doi: 10.1080/10749357.2022.2026563. Epub 2022 Feb 1.
  PMID: 35102816
  citation: Embrechts E, van der Waal C, Anseeuw D, van Buijnderen J, Leroij A, Lafosse C, Nijboer TC, Truijen S, Saeys W. Association between spatial neglect and impaired verticality perception after stroke: A systematic review. Ann Phys Rehabil Med. 2023 Apr;66(3):101700. doi: 10.1016/j.rehab.2022.101700. Epub 2022 Dec 1.
  PMID: 35963568
  citation: Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.
  PMID: 18678565
  citation: Bonan IV, Leman MC, Legargasson JF, Guichard JP, Yelnik AP. Evolution of subjective visual vertical perturbation after stroke. Neurorehabil Neural Repair. 2006 Dec;20(4):484-91. doi: 10.1177/1545968306289295.
  PMID: 17082504
  responsible party type: Principal Investigator
  investigator affiliation: Universiteit Antwerpen
  investigator full name: Wim Saeys
  investigator title: Professor Dr. Wim Saeys
  mesh term: Stroke
  sharing ipd: Undecided