<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/NCT04430153</url>
  </required_header>
  <id_info>
    <org_study_id>S64074</org_study_id>
    <secondary_id>1153320N</secondary_id>
    <nct_id>NCT04430153</nct_id>
  </id_info>
  <brief_title>What do I Think I Can do and What do I Really do: the Use of the Arm in Daily Life After Stroke</brief_title>
  <official_title>Investigating the Actual Daily-life Upper Limb Activity Profile in Relation to Observed and Perceived Function in the Chronic Phase Post Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Research Foundation Flanders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</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>
      This study was organized to investigate the real upper limb use in persons after stroke.&#xD;
      Persons after stroke often have problems moving their affected arm, leading to limitations in&#xD;
      performing simple tasks. In previous research in a group of 60 patients post stroke the&#xD;
      investigators investigated two things: they observed how patients can move their affected&#xD;
      arm, and the investigators asked patients to indicate how they think they can use their&#xD;
      affected arm. Surprisingly, the investigators concluded that in patients with a similar, good&#xD;
      observed arm use there were two groups: (1) a 'match' group, reporting they can use their arm&#xD;
      well, and (2) a 'mismatch' group, reporting they can not use their arm well. This project&#xD;
      will further investigate this last group. The investigators will now use sensor technology to&#xD;
      investigate the actual daily life arm use during daily life. The investigators hypothesize&#xD;
      this daily arm use will be lower in the mismatch group than in the group with good observed&#xD;
      and perceived ability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will perform a cross-sectional study to acquire insight into the actual&#xD;
      daily-life UL activity profile of patients in the chronic phase post stroke. A sample of 60&#xD;
      community-dwelling patients more than six months after stroke will be recruited and will be&#xD;
      investigated with both standardized clinical, patient-reported and sensor-based UL&#xD;
      assessments. Our sample will include three groups of 20 patients with (1) both low observed&#xD;
      and perceived function; (2) both good observed and perceived function; and (3) good observed&#xD;
      but low perceived function, i.e. the mismatch group.&#xD;
&#xD;
      To better understand this mismatch group, it is pivotal to investigate daily arm and hand use&#xD;
      in patients in the chronic phase after stroke as the investigators expect patients in the&#xD;
      mismatch group to have significantly reduced arm and hand use throughout the day. After all,&#xD;
      stroke rehabilitation interventions intend to improve patients' performance in daily life,&#xD;
      but the objective evaluation of this aim is a challenge. Standardized assessments performed&#xD;
      in the rehabilitation environment or patients' home do not validly reflect daily-life&#xD;
      upper-limb use. To achieve insight into the observed upper limb function, apart from using&#xD;
      internationally accepted observation-based assessments such as the FMA and SIS hand function,&#xD;
      monitoring patients after stroke will also be performed using sensor-based systems.&#xD;
&#xD;
      The investigators hypothesize the mismatch group will show a comparable daily-life UL&#xD;
      activity profile compared to patients with both low observed and perceived function. However,&#xD;
      when compared to patients with good observed and perceived function, the mismatch group shows&#xD;
      significantly reduced daily-life UL activity by means of sensor-based evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">May 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer motor assessment - upper extremity</measure>
    <time_frame>After inclusion</time_frame>
    <description>Investigation of overall motor impairment of the affected upper limb: shoulder, arm, wrist, hand and fingers.&#xD;
Minimum: 0. Maximum: 66. Higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke Impact Scale 3.0</measure>
    <time_frame>After inclusion</time_frame>
    <description>Self-reported outcome, measuring the impact of a stroke on activities, participation and quality of life, using the most affected body side.&#xD;
Minimum: 0. Maximum: 100, for each of the 9 domains assessed. Higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hours of use of each limb</measure>
    <time_frame>After 3 days of sensor-based assessment</time_frame>
    <description>Hours of use of each limb as measured with the accelerometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use ratio</measure>
    <time_frame>After 3 days of sensor-based assessment</time_frame>
    <description>Dividing hours of use of the affected limb by the hours of use of the non-affected limb</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnitude ratio</measure>
    <time_frame>After 3 days of sensor-based assessment</time_frame>
    <description>The natural log of the vector magnitude of the non-dominant limb (or affected limb) divided by the vector magnitude of the dominant (or non-affected) limb&#xD;
The natural log of the vector magnitude of the non-dominant limb (or affected limb) divided by the vector magnitude of the dominant (or non-affected) limb Natural log of the vector magnitude of the affected divided by the non-affected limb</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bilateral magnitude</measure>
    <time_frame>After 3 days of sensor-based assessment</time_frame>
    <description>Sum of the vector magnitude from the two limbs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>National Institutes of Health Stroke Scale (NIHSS)</measure>
    <time_frame>After inclusion</time_frame>
    <description>Stroke severity. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale (mRS)</measure>
    <time_frame>After inclusion</time_frame>
    <description>Disability. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. Minimum: 0. Maximum: 6. Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>After inclusion</time_frame>
    <description>Cognitive impairment. Minimum: 0. Maximum: 30. Higher scores mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Start Cancellation Test (SCT)</measure>
    <time_frame>After inclusion</time_frame>
    <description>Unilateral spatial neglect. Min: 0. Max: 54. Higher scores are better, scores &lt;44 indicate the presence of USN.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>After inclusion</time_frame>
    <description>Anxiety and depression. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Index (BI)</measure>
    <time_frame>After inclusion</time_frame>
    <description>Independence in activities of daily living. Minimum: 0. Maximum: 100. Higher scores mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Ambulation Categories (FAC)</measure>
    <time_frame>After inclusion</time_frame>
    <description>Walking ability. Minimum: 0. Maximum: 5. Higher scores mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire (IPAQ)</measure>
    <time_frame>After inclusion</time_frame>
    <description>Patient-reported physical activity. 3 levels, higher levels are better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log Amount of Use (MAL AOU) - Dutch version</measure>
    <time_frame>After inclusion</time_frame>
    <description>Amount the individual uses the paretic arm. 26 items, per item: min. 0, max. 5. Higher scores mean better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABILHAND</measure>
    <time_frame>After inclusion</time_frame>
    <description>Self-reported measure of (bi)manual ability in everyday activities. Rasch based logit scale. Higher logit scores mean better outcome.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Low match</arm_group_label>
    <description>A group with both low observed and perceived upper limb ability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Good match</arm_group_label>
    <description>A group with both good observed and perceived upper limb ability.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mismatch</arm_group_label>
    <description>A group with good observed but low perceived function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>&quot;Class 1 Medical Device&quot; CE certified devices: ActiGraph wGT3X-BT accelerometer</intervention_name>
    <description>Accelerometers on both patients' wrists will give insight into the daily life upper limb use.</description>
    <arm_group_label>Good match</arm_group_label>
    <arm_group_label>Low match</arm_group_label>
    <arm_group_label>Mismatch</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Sixty patients with chronic stroke (&gt;6 months post stroke) will be recruited&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) unilateral, supratentorial stroke as defined by WHO; (2) minimum 6 months after stroke,&#xD;
        and living in the community; (3) ≥ 18 years old; and (4) informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) a musculoskeletal and/or other neurological disorder such as previous stroke, head&#xD;
        injury, or Parkinson's disease that interfere with the protocol; and (2) severe&#xD;
        communication or cognitive deficits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geert Verheyden</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3001</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Prof Geert Verheyden</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT04430153
org study id: S64074
secondary id: 1153320N
nct id: NCT04430153
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was organized to investigate the real upper limb use in persons after stroke.
      Persons after stroke often have problems moving their affected arm, leading to limitations in
      performing simple tasks. In previous research in a group of 60 patients post stroke the
      investigators investigated two things: they observed how patients can move their affected
      arm, and the investigators asked patients to indicate how they think they can use their
      affected arm. Surprisingly, the investigators concluded that in patients with a similar, good
      observed arm use there were two groups: (1) a 'match' group, reporting they can use their arm
      well, and (2) a 'mismatch' group, reporting they can not use their arm well. This project
      will further investigate this last group. The investigators will now use sensor technology to
      investigate the actual daily life arm use during daily life. The investigators hypothesize
      this daily arm use will be lower in the mismatch group than in the group with good observed
      and perceived ability.
The investigators will perform a cross-sectional study to acquire insight into the actual
      daily-life UL activity profile of patients in the chronic phase post stroke. A sample of 60
      community-dwelling patients more than six months after stroke will be recruited and will be
      investigated with both standardized clinical, patient-reported and sensor-based UL
      assessments. Our sample will include three groups of 20 patients with (1) both low observed
      and perceived function; (2) both good observed and perceived function; and (3) good observed
      but low perceived function, i.e. the mismatch group.

      To better understand this mismatch group, it is pivotal to investigate daily arm and hand use
      in patients in the chronic phase after stroke as the investigators expect patients in the
      mismatch group to have significantly reduced arm and hand use throughout the day. After all,
      stroke rehabilitation interventions intend to improve patients' performance in daily life,
      but the objective evaluation of this aim is a challenge. Standardized assessments performed
      in the rehabilitation environment or patients' home do not validly reflect daily-life
      upper-limb use. To achieve insight into the observed upper limb function, apart from using
      internationally accepted observation-based assessments such as the FMA and SIS hand function,
      monitoring patients after stroke will also be performed using sensor-based systems.

      The investigators hypothesize the mismatch group will show a comparable daily-life UL
      activity profile compared to patients with both low observed and perceived function. However,
      when compared to patients with good observed and perceived function, the mismatch group shows
      significantly reduced daily-life UL activity by means of sensor-based evaluation.
observational model: Cohort
time perspective: Cross-Sectional
measure: Fugl-Meyer motor assessment - upper extremity
time frame: After inclusion
description: Investigation of overall motor impairment of the affected upper limb: shoulder, arm, wrist, hand and fingers.
Minimum: 0. Maximum: 66. Higher scores mean a better outcome.
measure: Stroke Impact Scale 3.0
time frame: After inclusion
description: Self-reported outcome, measuring the impact of a stroke on activities, participation and quality of life, using the most affected body side.
Minimum: 0. Maximum: 100, for each of the 9 domains assessed. Higher scores mean a better outcome.
measure: Hours of use of each limb
time frame: After 3 days of sensor-based assessment
description: Hours of use of each limb as measured with the accelerometer
measure: Use ratio
time frame: After 3 days of sensor-based assessment
description: Dividing hours of use of the affected limb by the hours of use of the non-affected limb
measure: Magnitude ratio
time frame: After 3 days of sensor-based assessment
description: The natural log of the vector magnitude of the non-dominant limb (or affected limb) divided by the vector magnitude of the dominant (or non-affected) limb
The natural log of the vector magnitude of the non-dominant limb (or affected limb) divided by the vector magnitude of the dominant (or non-affected) limb Natural log of the vector magnitude of the affected divided by the non-affected limb
measure: Bilateral magnitude
time frame: After 3 days of sensor-based assessment
description: Sum of the vector magnitude from the two limbs
measure: National Institutes of Health Stroke Scale (NIHSS)
time frame: After inclusion
description: Stroke severity. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.
measure: Modified Rankin Scale (mRS)
time frame: After inclusion
description: Disability. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. Minimum: 0. Maximum: 6. Higher scores mean worse outcome.
measure: Montreal Cognitive Assessment (MoCA)
time frame: After inclusion
description: Cognitive impairment. Minimum: 0. Maximum: 30. Higher scores mean better outcome.
measure: Start Cancellation Test (SCT)
time frame: After inclusion
description: Unilateral spatial neglect. Min: 0. Max: 54. Higher scores are better, scores <44 indicate the presence of USN.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: After inclusion
description: Anxiety and depression. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.
measure: Barthel Index (BI)
time frame: After inclusion
description: Independence in activities of daily living. Minimum: 0. Maximum: 100. Higher scores mean better outcome.
measure: Functional Ambulation Categories (FAC)
time frame: After inclusion
description: Walking ability. Minimum: 0. Maximum: 5. Higher scores mean better outcome.
measure: International Physical Activity Questionnaire (IPAQ)
time frame: After inclusion
description: Patient-reported physical activity. 3 levels, higher levels are better.
measure: Motor Activity Log Amount of Use (MAL AOU) - Dutch version
time frame: After inclusion
description: Amount the individual uses the paretic arm. 26 items, per item: min. 0, max. 5. Higher scores mean better outcome.
measure: ABILHAND
time frame: After inclusion
description: Self-reported measure of (bi)manual ability in everyday activities. Rasch based logit scale. Higher logit scores mean better outcome.
arm group label: Low match
description: A group with both low observed and perceived upper limb ability.
arm group label: Good match
description: A group with both good observed and perceived upper limb ability.
arm group label: Mismatch
description: A group with good observed but low perceived function.
intervention type: Other
intervention name: "Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer
description: Accelerometers on both patients' wrists will give insight into the daily life upper limb use.
arm group label: Good match
arm group label: Low match
arm group label: Mismatch
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Geert Verheyden
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Prof Geert Verheyden
investigator title: Professor
mesh term: Stroke
sharing ipd: No