<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/NCT03295630</url>
  </required_header>
  <id_info>
    <org_study_id>R1978</org_study_id>
    <nct_id>NCT03295630</nct_id>
  </id_info>
  <brief_title>Validity of an Actigraph Accelerometer Following Critical Illness</brief_title>
  <official_title>Criterion Validity of the Actigraph GT3X Accelerometer in Determination of Body Position and Walking in Hospital Ward Patients Recovering From Critical Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hull University Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hull University Teaching Hospitals NHS Trust</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>
      This study will determine whether an Actigraph GT3X accelerometer can identify body position&#xD;
      and quantify step count in a ward based population recovering from critical illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ward based patients recovering from critical illness who satisfy the inclusion criteria will&#xD;
      have an Actigraph GT3X accelerometer positioned on the thigh and ankle of the non dominant&#xD;
      leg. These will be used as an objective method of identifying adoption of lying, sitting and&#xD;
      standing postures and quantification of step count. Both placement sites will be investigated&#xD;
      in isolation. A further analysis will be undertaken to determine whether combining data from&#xD;
      both placement sites (ankle and thigh) is superior in identification of lying, sitting and&#xD;
      standing postures compared to an isolated single site. Accelerometer data will be compared&#xD;
      against direct observation as the criterion measure.&#xD;
&#xD;
      Patients will undertake a semi-structured movement protocol consisting of typical activities&#xD;
      undertaken by this population. These include lying in bed, transferring over the side of the&#xD;
      bed, sit to stand postural transfers (and the reverse), sitting in a chair and walking.&#xD;
      Observation periods will not exceed 3 hours. During this time all aspects of the movement&#xD;
      protocol will be completed.&#xD;
&#xD;
      The data from this study will be analysed to determine the validity of the Actigraph GT3X in&#xD;
      identification of body position and quantification of step count using the placement sites&#xD;
      described above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2016</start_date>
  <completion_date type="Actual">April 21, 2017</completion_date>
  <primary_completion_date type="Actual">April 21, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Ankle mounted Actigraph GT3X accelerometer</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ability of an Accelerometer to Identify Step Count</measure>
    <time_frame>Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol</time_frame>
    <description>Agreement between direct observation and the activity monitors (ankle and thigh placements in isolation) in determination of step count. The mean difference (95% Limits of Agreement) between observed step count and accelerometer quantified step count for the same walk were calculated. Negative values reflected an underestimation of observed step count by the accelerometer and positive values reflected an overestimation of step count.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comfort of Accelerometers</measure>
    <time_frame>Accelerometers were worn for a period not exceeding 3 hours</time_frame>
    <description>Participants were asked to rate their assessment of how comfortable the accelerometers were. They were requested to choose a statement on a five-point Likert Scale. The statements were:&#xD;
Very uncomfortable&#xD;
Somewhat uncomfortable&#xD;
Neither comfortable nor uncomfortable&#xD;
Somewhat comfortable&#xD;
Very comfortable&#xD;
Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Critical Care</condition>
  <condition>Walking</condition>
  <condition>Posture</condition>
  <arm_group>
    <arm_group_label>Actigraph GT3X accelerometer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accelerometer</intervention_name>
    <description>Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count.</description>
    <arm_group_label>Actigraph GT3X accelerometer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1 18 years of age or above.&#xD;
&#xD;
        2. Ventilated in excess of 48 hours during admission in the Intensive Care Unit (ICU).&#xD;
&#xD;
        3. Currently resident on a hospital ward (secondary care) following step down from ICU&#xD;
&#xD;
        4. Able to undertake all postural transfers independently or with minimal assistance (one&#xD;
        person only).&#xD;
&#xD;
        5. Able to mobilise short distances, either independently or with assistance from a walking&#xD;
        aid or one person.&#xD;
&#xD;
        6. Willing to permit application of two Actigraph GT3X accelerometers Each device weighs&#xD;
        27g with dimensions of 3.8cm x 3.7cm x 1.8cm.&#xD;
&#xD;
        7. Willing to consent to a period of direct observation for a length of time not exceeding&#xD;
        three hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to provide informed written consent themselves&#xD;
&#xD;
          2. Unwilling to consent to a period of observation not exceeding three hours.&#xD;
&#xD;
          3. Unable to make an informed decision about participation or demonstrating an inability&#xD;
             to interpret information or follow study instructions&#xD;
&#xD;
          4. Significant neurological or coordination impairment&#xD;
&#xD;
          5. Unable to speak or understand English.&#xD;
&#xD;
          6. Clostridium Difficile/ similar infection or unmanaged urinary incontinence.&#xD;
&#xD;
          7. Evidence/ diagnosis of peripheral vascular disease.&#xD;
&#xD;
          8. Lower limb amputation&#xD;
&#xD;
          9. Polytrauma which prevents the adoption or normal lying, sitting or standing postures,&#xD;
             or placement of the accelerometers&#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>Jayne Anderson, GradDipPhys</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hull University Teaching Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hull and East Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Hull</city>
        <state>East Yorkshire</state>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <results_first_submitted>March 13, 2019</results_first_submitted>
  <results_first_submitted_qc>October 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2019</results_first_posted>
  <last_update_submitted>October 4, 2019</last_update_submitted>
  <last_update_submitted_qc>October 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Accelerometry</keyword>
  <keyword>Validity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03295630/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03295630/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>20 hospital ward based participants recruited. Recruitment period September 2016 to April 2017</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Accelerometer (Single Group Recruited)</title>
          <description>Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg&#xD;
Accelerometer: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Accelerometer</title>
          <description>Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg&#xD;
Accelerometer: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.3" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Years</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.9" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of days receiving mechanical ventilation</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15" lower_limit="5.5" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ICU overall length of stay</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21" lower_limit="8.25" upper_limit="42.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Overall hospital length of stay</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35" lower_limit="17.25" upper_limit="64.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ability of an Accelerometer to Identify Step Count</title>
        <description>Agreement between direct observation and the activity monitors (ankle and thigh placements in isolation) in determination of step count. The mean difference (95% Limits of Agreement) between observed step count and accelerometer quantified step count for the same walk were calculated. Negative values reflected an underestimation of observed step count by the accelerometer and positive values reflected an overestimation of step count.</description>
        <time_frame>Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol</time_frame>
        <population>Investigation of agreement between accelerometer quantified step count (ankle and thigh in isolation) and observed step count</population>
        <group_list>
          <group group_id="O1">
            <title>Accelerometer</title>
            <description>Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg&#xD;
Accelerometer: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count</description>
          </group>
        </group_list>
        <measure>
          <title>Ability of an Accelerometer to Identify Step Count</title>
          <description>Agreement between direct observation and the activity monitors (ankle and thigh placements in isolation) in determination of step count. The mean difference (95% Limits of Agreement) between observed step count and accelerometer quantified step count for the same walk were calculated. Negative values reflected an underestimation of observed step count by the accelerometer and positive values reflected an overestimation of step count.</description>
          <population>Investigation of agreement between accelerometer quantified step count (ankle and thigh in isolation) and observed step count</population>
          <units>Observed steps</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" lower_limit="15" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Difference (steps) between accelerometer quantified step count (thigh placement) and observed step count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-17.7</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Correlation between accelerometer quantified step count (thigh placement) and observed step count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Intraclass Correlation Coefficient</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Difference (steps) between accelerometer quantified steps (ankle placement) and observed step count</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.84</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Correlation between accelerometer quantified steps (ankle placement) and observed steps</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Intraclass Correlation Coefficient</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comfort of Accelerometers</title>
        <description>Participants were asked to rate their assessment of how comfortable the accelerometers were. They were requested to choose a statement on a five-point Likert Scale. The statements were:&#xD;
Very uncomfortable&#xD;
Somewhat uncomfortable&#xD;
Neither comfortable nor uncomfortable&#xD;
Somewhat comfortable&#xD;
Very comfortable&#xD;
Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear.</description>
        <time_frame>Accelerometers were worn for a period not exceeding 3 hours</time_frame>
        <population>Participants were asked to rate accelerometer comfort using a 5-point Likert Scale with the following statements:&#xD;
'Very comfortable', 'Somewhat comfortable', 'Neither comfortable or uncomfortable', Somewhat uncomfortable', Very uncomfortable'</population>
        <group_list>
          <group group_id="O1">
            <title>Accelerometer</title>
            <description>Participants rating of accelerometer comfort using a 5-point Likert Scale</description>
          </group>
        </group_list>
        <measure>
          <title>Comfort of Accelerometers</title>
          <description>Participants were asked to rate their assessment of how comfortable the accelerometers were. They were requested to choose a statement on a five-point Likert Scale. The statements were:&#xD;
Very uncomfortable&#xD;
Somewhat uncomfortable&#xD;
Neither comfortable nor uncomfortable&#xD;
Somewhat comfortable&#xD;
Very comfortable&#xD;
Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear.</description>
          <population>Participants were asked to rate accelerometer comfort using a 5-point Likert Scale with the following statements:&#xD;
'Very comfortable', 'Somewhat comfortable', 'Neither comfortable or uncomfortable', Somewhat uncomfortable', Very uncomfortable'</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very Comfortable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat comfortable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neither comfortable or uncomfortable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat uncomfortable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very uncomfortable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not exceeding 3 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Accelerometer (Single Group Recruited)</title>
          <description>Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg&#xD;
Accelerometer: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jayne Anderson</name_or_title>
      <organization>Hull University Teaching Hospitals NHS Trust</organization>
      <phone>01482 875875 ext 5099</phone>
      <email>jayne.anderson@hey.nhs.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03295630
org study id: R1978
nct id: NCT03295630
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will determine whether an Actigraph GT3X accelerometer can identify body position
      and quantify step count in a ward based population recovering from critical illness.
Ward based patients recovering from critical illness who satisfy the inclusion criteria will
      have an Actigraph GT3X accelerometer positioned on the thigh and ankle of the non dominant
      leg. These will be used as an objective method of identifying adoption of lying, sitting and
      standing postures and quantification of step count. Both placement sites will be investigated
      in isolation. A further analysis will be undertaken to determine whether combining data from
      both placement sites (ankle and thigh) is superior in identification of lying, sitting and
      standing postures compared to an isolated single site. Accelerometer data will be compared
      against direct observation as the criterion measure.

      Patients will undertake a semi-structured movement protocol consisting of typical activities
      undertaken by this population. These include lying in bed, transferring over the side of the
      bed, sit to stand postural transfers (and the reverse), sitting in a chair and walking.
      Observation periods will not exceed 3 hours. During this time all aspects of the movement
      protocol will be completed.

      The data from this study will be analysed to determine the validity of the Actigraph GT3X in
      identification of body position and quantification of step count using the placement sites
      described above.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Ankle mounted Actigraph GT3X accelerometer
primary purpose: Other
masking: None (Open Label)
measure: Ability of an Accelerometer to Identify Step Count
time frame: Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol
description: Agreement between direct observation and the activity monitors (ankle and thigh placements in isolation) in determination of step count. The mean difference (95% Limits of Agreement) between observed step count and accelerometer quantified step count for the same walk were calculated. Negative values reflected an underestimation of observed step count by the accelerometer and positive values reflected an overestimation of step count.
measure: Comfort of Accelerometers
time frame: Accelerometers were worn for a period not exceeding 3 hours
description: Participants were asked to rate their assessment of how comfortable the accelerometers were. They were requested to choose a statement on a five-point Likert Scale. The statements were:
Very uncomfortable
Somewhat uncomfortable
Neither comfortable nor uncomfortable
Somewhat comfortable
Very comfortable
Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear.
arm group label: Actigraph GT3X accelerometer
arm group type: Other
description: Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg
intervention type: Device
intervention name: Accelerometer
description: Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count.
arm group label: Actigraph GT3X accelerometer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jayne Anderson, GradDipPhys
role: Principal Investigator
affiliation: Hull University Teaching Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 