<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/NCT04399759</url>
  </required_header>
  <id_info>
    <org_study_id>CTH-108-2-5-029</org_study_id>
    <nct_id>NCT04399759</nct_id>
  </id_info>
  <brief_title>Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke</brief_title>
  <official_title>Investigation of the Effect on Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taipei University of Nursing and Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taipei University of Nursing and Health Sciences</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>
      The purpose of this study was to conduct a randomized clinical trial. Implement instrumental&#xD;
      daily activities of daily living (A-IADL) in home rehabilitation. To explore the effect of&#xD;
      A-IADL on stroke patients' movement, cognition, social participation, daily life function and&#xD;
      quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects were randomized to intervention group and control group. The experiment was designed&#xD;
      as randomized cross-over control trial. The primary outcome included 11 measures, Fugl-Meyer&#xD;
      Assessment, Balance computerized adaptive testing, Mini Mental State Examination,&#xD;
      Participation Measure-3 Domains ,4 Dimensions, Canadian Occupational Performance Measure,&#xD;
      Barthel Index-based Supplementary Scales, Frenchay Activities Index, Lawnton Instrumental&#xD;
      Activities of Daily Living, stroke impact scale, Stroke Self-Efficacy Questionnaire, and&#xD;
      Kingston Caregiver Stress Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance computerized adaptive testing</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini Mental State Examination</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participation Measure-3 Domains ,4 Dimensions</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Canadian Occupational Performance Measure</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10. A higher score indicates better occupational performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barthel Index (BI) -based Supplementary Scales</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frenchay Activities Index</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Frenchay Activities Index is a measure of instrumental activities of daily living for use with patients recovering from stroke. The score ranges is 0 to 45. A higher score indicates better instrumental activities of daily living.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lawnton Instrumental Activities of Daily Living</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Lawnton Instrumental Activities of Daily Living assesses instrumental activities of daily living.The score ranges is 0 to 8. A higher score indicates better instrumental activities of daily living.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke Impact Scale</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Stroke Impact Scale assesses other dimensions of health-related quality of life: emotion, communication, memory and thinking, and social role function.The score ranges is 59 to 295. A lower score indicates the quality of life less affected by stroke.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke Self-Efficacy Questionnaire</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Stroke Self-Efficacy Questionnaire is a self-report scale measuring self-efficacy judgments in specific domains of functioning post stroke. The score ranges is 0 to 130. A higher score indicates better self-efficacy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kingston Caregiver Stress Scale</measure>
    <time_frame>Baseline to 6 weeks</time_frame>
    <description>The Kingston Caregiver Stress Scale is a self-report scale measuring caregiver stress. The score ranges is 10 to 50. A higher score indicates greater stress.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Stroke</condition>
  <condition>Activities of Daily Living</condition>
  <arm_group>
    <arm_group_label>A-IADL Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approach-Instrumental Activities of Daily Living in home</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Home health education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Approach-Instrumental Activities of Daily Living</intervention_name>
    <description>Individualized instrumental activities of daily living training</description>
    <arm_group_label>A-IADL Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home health education</intervention_name>
    <description>Individualized home health education</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 20 years&#xD;
&#xD;
          -  Diagnosis of stroke&#xD;
&#xD;
          -  The modified Rankin Scale : 2~4&#xD;
&#xD;
          -  Keep sitting for half an hour by himself/herself&#xD;
&#xD;
          -  Follow instructions&#xD;
&#xD;
          -  Willing to sign the subject's consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of dementia&#xD;
&#xD;
          -  History of orthopedic diseases or peripheral nerve injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>En-Chi Chiu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>National Taipei University of Nursing and Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardinal Tien Hospital</name>
      <address>
        <city>New Taipei City</city>
        <state>Xindian Dist</state>
        <zip>231403</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taipei University of Nursing and Health Sciences</investigator_affiliation>
    <investigator_full_name>En-Chi Chiu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Activities of Daily Living</keyword>
  <keyword>Home Care Services</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT04399759
org study id: CTH-108-2-5-029
nct id: NCT04399759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to conduct a randomized clinical trial. Implement instrumental
      daily activities of daily living (A-IADL) in home rehabilitation. To explore the effect of
      A-IADL on stroke patients' movement, cognition, social participation, daily life function and
      quality of life.
Subjects were randomized to intervention group and control group. The experiment was designed
      as randomized cross-over control trial. The primary outcome included 11 measures, Fugl-Meyer
      Assessment, Balance computerized adaptive testing, Mini Mental State Examination,
      Participation Measure-3 Domains ,4 Dimensions, Canadian Occupational Performance Measure,
      Barthel Index-based Supplementary Scales, Frenchay Activities Index, Lawnton Instrumental
      Activities of Daily Living, stroke impact scale, Stroke Self-Efficacy Questionnaire, and
      Kingston Caregiver Stress Scale.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fugl-Meyer Assessment
time frame: Baseline to 6 weeks
description: The Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.
measure: Balance computerized adaptive testing
time frame: Baseline to 6 weeks
description: The Balance computerized adaptive testing is a test about stroke patients, includes movement, balance, activities of daily living.
measure: Mini Mental State Examination
time frame: Baseline to 6 weeks
description: The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.
measure: Participation Measure-3 Domains ,4 Dimensions
time frame: Baseline to 6 weeks
description: The Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation.
measure: Canadian Occupational Performance Measure
time frame: Baseline to 6 weeks
description: The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10. A higher score indicates better occupational performance.
measure: Barthel Index (BI) -based Supplementary Scales
time frame: Baseline to 6 weeks
description: The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.
measure: Frenchay Activities Index
time frame: Baseline to 6 weeks
description: The Frenchay Activities Index is a measure of instrumental activities of daily living for use with patients recovering from stroke. The score ranges is 0 to 45. A higher score indicates better instrumental activities of daily living.
measure: Lawnton Instrumental Activities of Daily Living
time frame: Baseline to 6 weeks
description: The Lawnton Instrumental Activities of Daily Living assesses instrumental activities of daily living.The score ranges is 0 to 8. A higher score indicates better instrumental activities of daily living.
measure: Stroke Impact Scale
time frame: Baseline to 6 weeks
description: The Stroke Impact Scale assesses other dimensions of health-related quality of life: emotion, communication, memory and thinking, and social role function.The score ranges is 59 to 295. A lower score indicates the quality of life less affected by stroke.
measure: Stroke Self-Efficacy Questionnaire
time frame: Baseline to 6 weeks
description: The Stroke Self-Efficacy Questionnaire is a self-report scale measuring self-efficacy judgments in specific domains of functioning post stroke. The score ranges is 0 to 130. A higher score indicates better self-efficacy.
measure: Kingston Caregiver Stress Scale
time frame: Baseline to 6 weeks
description: The Kingston Caregiver Stress Scale is a self-report scale measuring caregiver stress. The score ranges is 10 to 50. A higher score indicates greater stress.
arm group label: A-IADL Group
arm group type: Experimental
description: Approach-Instrumental Activities of Daily Living in home
arm group label: Control group
arm group type: Active Comparator
description: Home health education
intervention type: Behavioral
intervention name: Approach-Instrumental Activities of Daily Living
description: Individualized instrumental activities of daily living training
arm group label: A-IADL Group
intervention type: Behavioral
intervention name: Home health education
description: Individualized home health education
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: En-Chi Chiu, PhD
role: Study Director
affiliation: National Taipei University of Nursing and Health Sciences
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taipei University of Nursing and Health Sciences
investigator full name: En-Chi Chiu
investigator title: Associate Professor
mesh term: Stroke