<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/NCT02264470</url>
  </required_header>
  <id_info>
    <org_study_id>CUPersson</org_study_id>
    <nct_id>NCT02264470</nct_id>
  </id_info>
  <brief_title>Fall Study in Gothenburg (FallsGOT)</brief_title>
  <acronym>FallsGOT</acronym>
  <official_title>Identification of Fall Risk in Patients With Stroke During Inpatient Rehabilitation on a Stroke Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Falls after stroke are common. Previous research has shown that almost every other, 48%, of&#xD;
      patients with a first-ever stroke fell at least once during the first year after stroke (1).&#xD;
      Moreover, most of the patients fell during the first three months after stroke onset.&#xD;
      However, the exact time-point for the falls was not analyzed (1). In addition, many patients&#xD;
      are falling already during hospital stay (2-5). Reducing the number of falls during inpatient&#xD;
      rehabilitation on a stroke unit is a high-priority mission. Greater knowledge concerning the&#xD;
      factors that best predict falls is eligible.&#xD;
&#xD;
      The aim of the study is to analyze the significance of different physiological, psychological&#xD;
      and medical factors for predicting the risk of falling in patients with stroke per day of&#xD;
      care at a stroke unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample size assessment: According statistical consultation it is required to include at least&#xD;
      150 patients. The target figure is to include 500 patients. That number enables sub analyzes.&#xD;
&#xD;
      Inclusion criterion: All patients with clinical stroke (infarction as bleeding, first-time or&#xD;
      recurrent) at the stroke unit 354 will be asked for study participation.&#xD;
&#xD;
      Exclusion criterion: Patients not willing to participate in the study.&#xD;
&#xD;
      The response variable is fall. A fall is defined as an event which results in a person coming&#xD;
      to rest inadvertently on the ground or floor or other lower level. The definition of a fall&#xD;
      refers to the World Health Organization (http://www.who.int/mediacentre/factsheets/fs344/en/&#xD;
      2014-09-29). Data regarding falls will be collected from MedControl Pro (without any official&#xD;
      possible expansions). MedControl Pro is a web based program for deviations. For validation of&#xD;
      data concerning falls, assessment of medical journals will also be implemented.&#xD;
&#xD;
      The significance of the following covariates will be used in the analyses:&#xD;
&#xD;
        1. The patient's confidence in their own balance (postural control).&#xD;
&#xD;
           - Do you feel that your balance (postural control) is impaired?&#xD;
&#xD;
        2. Fear of falling&#xD;
&#xD;
           - Are you afraid to fall? (Fear of falling)&#xD;
&#xD;
        3. Postural control in everyday activities&#xD;
&#xD;
             -  The modified version of the Postural Assessment Scale for Stroke Patients (SwePASS)&#xD;
&#xD;
        4. Postural control; tandem stance (A decisive moment?)&#xD;
&#xD;
           - Do the patient manages tandem stance 30 s or not?/use of scale 0-4&#xD;
&#xD;
        5. Risk taking behaviour&#xD;
&#xD;
             -  Is the patient inclined to take a risk in tandem stance?&#xD;
&#xD;
        6. Self reported previous physical activity (PA) level.&#xD;
&#xD;
           - Grimby &amp; Saltin scale and/or 150 minutes of PA/week or not&#xD;
&#xD;
        7. Cognitive ability&#xD;
&#xD;
           - Montreal Cognitive Assessment (MoCa)&#xD;
&#xD;
        8. Medication&#xD;
&#xD;
           - Registration of drugs and their Anatomical Therapeutic Chemical (ATC) classification&#xD;
           codes&#xD;
&#xD;
        9. Blood pressure&#xD;
&#xD;
           - Blood pressure and pulse lying and after 1 and 3 minutes standing&#xD;
&#xD;
       10. The use of walking aids&#xD;
&#xD;
       11. The use of wheelchair&#xD;
&#xD;
       12. Age&#xD;
&#xD;
       13. Sex&#xD;
&#xD;
       14. Length of stay (in days) on the stroke unit.&#xD;
&#xD;
      In addition, the National Institutes of Health Stroke Scale (NIHSS) result will be registered&#xD;
      and used to describe the study population.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
      Data collection will take place once, as fast as possible but at the latest 4 days after&#xD;
      admission to the stroke unit. There are two exceptions:&#xD;
&#xD;
      First, data collection regarding drugs will take place day 4 after admission. However, in&#xD;
      case of a fall before day 4 after admission, the data collection will be based on the drug&#xD;
      list the current fall day.&#xD;
&#xD;
      Second, data concerning cognition using MoCA will be performed once sometime during the&#xD;
      stroke-unit stay (due to organisation issues). That is, not at any particular time, but the&#xD;
      greater the suspicion of cognitive impairment, the later during the stroke unit stay.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The poisson regression analysis will be used in order to address number of falls (fall risk)&#xD;
      per day and night at the stroke unit. Poisson regression takes into account the wide&#xD;
      variation in length of stay at the stroke unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</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>Fall/falls using MedControl Pro (no official possible expansions) and the medical journal</measure>
    <time_frame>The participants will be followed and any fall will be registered during the hospital stay on a stroke unit, an expected average of 15 days.</time_frame>
    <description>The primary outcome, one fall, will be defined &quot;as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level&quot;, according to the World Health Organization. Fall data is based on the numbers and description of falls documented in the medical journal and the falls registered in the MedControl. MedControl is a web-based system for deviations, here referred to falls. From the MedControl, time points (day, evening or night) and circumstances for and consequences of a fall/several falls (injury or not) will be used and registered. The estimated period of time over which a fall is/several falls are registered, extends from the admission day up to the day for discharge, an expected average of up to 15 days. The primary outcome measure will be assessed retrospectively from MedControl Pro and GeM within an expected average of a week after the discharge from the stroke unit.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Postural control in everyday activities using SwePASS (Modified version of the Postural Assessment Scale for Stroke Patients)</measure>
    <time_frame>Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit</time_frame>
    <description>An clinical ordinal scale to assess postural control after stroke. Postural control referred to here is the ability to stabilize body in everyday activities. The scale contains 12 items, each scored between 0 and 3, where the higher the number is expected to correspond to the higher capacity in postural control and vice versa.</description>
  </other_outcome>
  <other_outcome>
    <measure>Postural control; tandem stance</measure>
    <time_frame>Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit</time_frame>
    <description>An ordinal item from the Berg balance scale for assessment of balance</description>
  </other_outcome>
  <other_outcome>
    <measure>Previous physical activity level using Grimby &amp; Saltin's scale</measure>
    <time_frame>Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit</time_frame>
    <description>An ordinal scale for assessment of self-reported previous physical activity level.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognition using MoCA (Montreal Cognitive Assessment)</measure>
    <time_frame>Once during the inpatient rehabilitation/hospital stay on a stroke unit</time_frame>
    <description>A one page 30 point clinical test containing different parts (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) to assess several cognitive domains.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">505</enrollment>
  <condition>Accidental Falls</condition>
  <arm_group>
    <arm_group_label>Patients with clinical stroke</arm_group_label>
    <description>All patients with stroke, 18 years or older, are asked for participation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Not relevant</intervention_name>
    <description>Not relevant</description>
    <arm_group_label>Patients with clinical stroke</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The group will consist of consecutively included patients with clinical stroke at the&#xD;
        stroke unit at Sahlgrenska University Hospital/Östra, Gothenburg.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinical stroke, whether first-ever or recurrent stroke and whether&#xD;
             caused by cerebral infarction or cerebral hemorrhage&#xD;
&#xD;
          -  Patients 18 years old or older&#xD;
&#xD;
        Exclusion Criterion:&#xD;
&#xD;
          -  Patients unwilling to participate in the study.&#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>Carina U Persson, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carina U Persson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carina U Persson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital/Östra</name>
      <address>
        <city>Gothenburg</city>
        <state>Diagnosvägen 1</state>
        <zip>416 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prediction</keyword>
  <keyword>Falls</keyword>
  <keyword>Stroke</keyword>
  <!-- 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/NCT02264470
org study id: CUPersson
nct id: NCT02264470
lead sponsor: 
has dmc: Yes
Falls after stroke are common. Previous research has shown that almost every other, 48%, of
      patients with a first-ever stroke fell at least once during the first year after stroke (1).
      Moreover, most of the patients fell during the first three months after stroke onset.
      However, the exact time-point for the falls was not analyzed (1). In addition, many patients
      are falling already during hospital stay (2-5). Reducing the number of falls during inpatient
      rehabilitation on a stroke unit is a high-priority mission. Greater knowledge concerning the
      factors that best predict falls is eligible.

      The aim of the study is to analyze the significance of different physiological, psychological
      and medical factors for predicting the risk of falling in patients with stroke per day of
      care at a stroke unit.
Sample size assessment: According statistical consultation it is required to include at least
      150 patients. The target figure is to include 500 patients. That number enables sub analyzes.

      Inclusion criterion: All patients with clinical stroke (infarction as bleeding, first-time or
      recurrent) at the stroke unit 354 will be asked for study participation.

      Exclusion criterion: Patients not willing to participate in the study.

      The response variable is fall. A fall is defined as an event which results in a person coming
      to rest inadvertently on the ground or floor or other lower level. The definition of a fall
      refers to the World Health Organization (http://www.who.int/mediacentre/factsheets/fs344/en/
      2014-09-29). Data regarding falls will be collected from MedControl Pro (without any official
      possible expansions). MedControl Pro is a web based program for deviations. For validation of
      data concerning falls, assessment of medical journals will also be implemented.

      The significance of the following covariates will be used in the analyses:

        1. The patient's confidence in their own balance (postural control).

           - Do you feel that your balance (postural control) is impaired?

        2. Fear of falling

           - Are you afraid to fall? (Fear of falling)

        3. Postural control in everyday activities

             -  The modified version of the Postural Assessment Scale for Stroke Patients (SwePASS)

        4. Postural control; tandem stance (A decisive moment?)

           - Do the patient manages tandem stance 30 s or not?/use of scale 0-4

        5. Risk taking behaviour

             -  Is the patient inclined to take a risk in tandem stance?

        6. Self reported previous physical activity (PA) level.

           - Grimby & Saltin scale and/or 150 minutes of PA/week or not

        7. Cognitive ability

           - Montreal Cognitive Assessment (MoCa)

        8. Medication

           - Registration of drugs and their Anatomical Therapeutic Chemical (ATC) classification
           codes

        9. Blood pressure

           - Blood pressure and pulse lying and after 1 and 3 minutes standing

       10. The use of walking aids

       11. The use of wheelchair

       12. Age

       13. Sex

       14. Length of stay (in days) on the stroke unit.

      In addition, the National Institutes of Health Stroke Scale (NIHSS) result will be registered
      and used to describe the study population.

      Data collection:

      Data collection will take place once, as fast as possible but at the latest 4 days after
      admission to the stroke unit. There are two exceptions:

      First, data collection regarding drugs will take place day 4 after admission. However, in
      case of a fall before day 4 after admission, the data collection will be based on the drug
      list the current fall day.

      Second, data concerning cognition using MoCA will be performed once sometime during the
      stroke-unit stay (due to organisation issues). That is, not at any particular time, but the
      greater the suspicion of cognitive impairment, the later during the stroke unit stay.

      Statistical analysis:

      The poisson regression analysis will be used in order to address number of falls (fall risk)
      per day and night at the stroke unit. Poisson regression takes into account the wide
      variation in length of stay at the stroke unit.
observational model: Cohort
time perspective: Prospective
measure: Fall/falls using MedControl Pro (no official possible expansions) and the medical journal
time frame: The participants will be followed and any fall will be registered during the hospital stay on a stroke unit, an expected average of 15 days.
description: The primary outcome, one fall, will be defined "as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level", according to the World Health Organization. Fall data is based on the numbers and description of falls documented in the medical journal and the falls registered in the MedControl. MedControl is a web-based system for deviations, here referred to falls. From the MedControl, time points (day, evening or night) and circumstances for and consequences of a fall/several falls (injury or not) will be used and registered. The estimated period of time over which a fall is/several falls are registered, extends from the admission day up to the day for discharge, an expected average of up to 15 days. The primary outcome measure will be assessed retrospectively from MedControl Pro and GeM within an expected average of a week after the discharge from the stroke unit.
measure: Postural control in everyday activities using SwePASS (Modified version of the Postural Assessment Scale for Stroke Patients)
time frame: Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit
description: An clinical ordinal scale to assess postural control after stroke. Postural control referred to here is the ability to stabilize body in everyday activities. The scale contains 12 items, each scored between 0 and 3, where the higher the number is expected to correspond to the higher capacity in postural control and vice versa.
measure: Postural control; tandem stance
time frame: Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit
description: An ordinal item from the Berg balance scale for assessment of balance
measure: Previous physical activity level using Grimby & Saltin's scale
time frame: Once as fast as possible from the admission day but at the latest 4 days after the admission to the stroke unit
description: An ordinal scale for assessment of self-reported previous physical activity level.
measure: Cognition using MoCA (Montreal Cognitive Assessment)
time frame: Once during the inpatient rehabilitation/hospital stay on a stroke unit
description: A one page 30 point clinical test containing different parts (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) to assess several cognitive domains.
arm group label: Patients with clinical stroke
description: All patients with stroke, 18 years or older, are asked for participation.
intervention type: Other
intervention name: Not relevant
description: Not relevant
arm group label: Patients with clinical stroke
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carina U Persson, PhD
role: Study Director
affiliation: Göteborg University
last name: Carina U Persson, PhD
role: Principal Investigator
affiliation: Göteborg University
last name: Carina U Persson, PhD
role: Study Chair
affiliation: Göteborg University
facility: 
country: Sweden
responsible party type: Sponsor