<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/NCT04489563</url>
  </required_header>
  <id_info>
    <org_study_id>i-ACT elderly</org_study_id>
    <nct_id>NCT04489563</nct_id>
  </id_info>
  <brief_title>Feasibility Study of i-ACT in Aged Persons</brief_title>
  <acronym>i-ACT-aged</acronym>
  <official_title>Intelligent Activity-based Client-centred Training (i-ACT) in Aged Persons</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PXL University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PXL University College</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>
      A mix-method cross-sectional feasibility study performed in five aged care institutes in&#xD;
      Flanders, Belgium. A convenience sample of 48 aged persons was recruited and 12 supervisors&#xD;
      (i.e. occupational therapy students and therapists).&#xD;
&#xD;
      Aged persons received a 20-30 minutes test with a technology-based system, i.e. intelligent&#xD;
      Activity-based Client-centred Training system (i-ACT). The i-ACT consists of the Microsoft&#xD;
      Kinect and adapted software in which movements can be recorded and training parameters can be&#xD;
      set by supervisors.&#xD;
&#xD;
      During and after the test, the thinking aloud method was used. After the test, the Intrinsic&#xD;
      Motivation Inventory, the System Usability Scale, and the Credibility/Expectancy&#xD;
      Questionnaire were administered in the aged persons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">May 12, 2019</completion_date>
  <primary_completion_date type="Actual">May 12, 2019</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>A group of aged persons and their supervisors in day care facilities or nursing homes participated in this study to investigate the feasibility of the i-ACT system for use to engage and motivate aged persons in institutional facilities to perform physical activity. The aged persons received a 20-30 minutes test period with the self-developed programme of the i-ACT (based on hard- and software of the Microsoft Kinect). During and after the test, the feedback of the participants was noted by the supervisor (using the thinking aloud method). After the test, 3 questionnaires were conducted, i.e. the Intrinsic Motivation Inventory (IMI), System Usability Scale (SUS), and Credibility/Expectancy Questionnaire (CEQ).&#xD;
The feedback from the supervisors was also noted as part of the thinking aloud method to gather as much information as needed to adapt the prototype of the i-ACT system towards the wishes and needs from aged persons.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intrinsic motivation</measure>
    <time_frame>30 minutes</time_frame>
    <description>Using the Intrinsic Motivation Inventory to record motivational aspects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usability of i-ACT</measure>
    <time_frame>10 minutes</time_frame>
    <description>Using the System Usability Scale to explore the usability of i-ACT in aged persons. The System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of 72.5 or higher is considered good and above 85.0 is excellent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Credibility/expectancy</measure>
    <time_frame>10 minutes</time_frame>
    <description>Using the Credibility/Expectancy Questionnaire to research the credibility and expectancy of aged persons when using the i-ACT for physical activity. It is one test that consists of 2 subscales, i.e. credibility and expectancy, and scores range from 1 (totally not) to 9 (totally yes) and percentages. The percentages are converted to scores on a scale of 1 to 9/ The maximum score on each subscale is 27. A score of 13.5 is considered neutral, everything above 13.5 is positive while everything under 13.5 is considered negative.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Feasibility of a Technology-based System in Aged Person</condition>
  <arm_group>
    <arm_group_label>Aged persons</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A feasibility test of 20-30 minutes in aged persons with an adapted Kinect-based system, i.e. i-ACT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>i-ACT</intervention_name>
    <description>Performing exercises with an adapted motion detection device (i.ACT) for 20-30 minutes.</description>
    <arm_group_label>Aged persons</arm_group_label>
    <other_name>Kinect</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a client of the participating centres&#xD;
&#xD;
          -  cognitively able to understand and respond to questions&#xD;
&#xD;
          -  follow up instructions&#xD;
&#xD;
          -  understand and speak the Dutch language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe spasticity that unables participants to perform exercises&#xD;
&#xD;
          -  severe visual impairment (e.g. blindness, cataract, etc.)&#xD;
&#xD;
          -  severe communication disorder that unables participants to understand and follow up&#xD;
             instructions (e.g. aphasia, agnosia, etc.)&#xD;
&#xD;
          -  persons who use electric wheelchairs who are not able to make a transfer towards a&#xD;
             chair.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Plankeweeke</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Begralim</name>
      <address>
        <city>Riemst</city>
        <state>Limburg</state>
        <zip>3770</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Begralim</name>
      <address>
        <city>Tongeren</city>
        <state>Limburg</state>
        <zip>3717</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DVC H. Catharina</name>
      <address>
        <city>Zonhoven</city>
        <state>Limburg</state>
        <zip>3520</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WZC H. Catharina</name>
      <address>
        <city>Zonhoven</city>
        <state>Limburg</state>
        <zip>3520</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>aged persons</keyword>
  <keyword>technology</keyword>
  <keyword>client-centred</keyword>
  <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/NCT04489563
org study id: i-ACT elderly
nct id: NCT04489563
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A mix-method cross-sectional feasibility study performed in five aged care institutes in
      Flanders, Belgium. A convenience sample of 48 aged persons was recruited and 12 supervisors
      (i.e. occupational therapy students and therapists).

      Aged persons received a 20-30 minutes test with a technology-based system, i.e. intelligent
      Activity-based Client-centred Training system (i-ACT). The i-ACT consists of the Microsoft
      Kinect and adapted software in which movements can be recorded and training parameters can be
      set by supervisors.

      During and after the test, the thinking aloud method was used. After the test, the Intrinsic
      Motivation Inventory, the System Usability Scale, and the Credibility/Expectancy
      Questionnaire were administered in the aged persons.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A group of aged persons and their supervisors in day care facilities or nursing homes participated in this study to investigate the feasibility of the i-ACT system for use to engage and motivate aged persons in institutional facilities to perform physical activity. The aged persons received a 20-30 minutes test period with the self-developed programme of the i-ACT (based on hard- and software of the Microsoft Kinect). During and after the test, the feedback of the participants was noted by the supervisor (using the thinking aloud method). After the test, 3 questionnaires were conducted, i.e. the Intrinsic Motivation Inventory (IMI), System Usability Scale (SUS), and Credibility/Expectancy Questionnaire (CEQ).
The feedback from the supervisors was also noted as part of the thinking aloud method to gather as much information as needed to adapt the prototype of the i-ACT system towards the wishes and needs from aged persons.
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Intrinsic motivation
time frame: 30 minutes
description: Using the Intrinsic Motivation Inventory to record motivational aspects
measure: Usability of i-ACT
time frame: 10 minutes
description: Using the System Usability Scale to explore the usability of i-ACT in aged persons. The System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of 72.5 or higher is considered good and above 85.0 is excellent.
measure: Credibility/expectancy
time frame: 10 minutes
description: Using the Credibility/Expectancy Questionnaire to research the credibility and expectancy of aged persons when using the i-ACT for physical activity. It is one test that consists of 2 subscales, i.e. credibility and expectancy, and scores range from 1 (totally not) to 9 (totally yes) and percentages. The percentages are converted to scores on a scale of 1 to 9/ The maximum score on each subscale is 27. A score of 13.5 is considered neutral, everything above 13.5 is positive while everything under 13.5 is considered negative.
arm group label: Aged persons
arm group type: Other
description: A feasibility test of 20-30 minutes in aged persons with an adapted Kinect-based system, i.e. i-ACT.
intervention type: Device
intervention name: i-ACT
description: Performing exercises with an adapted motion detection device (i.ACT) for 20-30 minutes.
arm group label: Aged persons
other name: Kinect
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No