<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/NCT03828851</url>
  </required_header>
  <id_info>
    <org_study_id>201712067RIND</org_study_id>
    <nct_id>NCT03828851</nct_id>
  </id_info>
  <brief_title>Development of Domiciliary Program on Improving Activities of Daily Living Program for Patients With Stroke</brief_title>
  <official_title>Development of Domiciliary Program on Improving Activities of Daily Living Program for Patients With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      The purpose of this study was to investigate the effects of the Domiciliary care- Activities&#xD;
      of Daily Living program on activities of daily living (ADL), motor, cognition, perception,&#xD;
      sensory, quality of life, and depression for patients with stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Administering ADL and recovery of ADL functions are the primary efficacy indicators in&#xD;
      long-term care and the main treatment goals in rehabilitation for patients with stroke.&#xD;
      Residential rehabilitation is a direct way to observe patients' living environment and&#xD;
      provides feasible ADL treatment plans for patients with stroke living at home or in the&#xD;
      community. The purpose of this study was to investigate the effects of the Domiciliary care-&#xD;
      Activities of Daily Living program on activities of daily living, motor, cognition,&#xD;
      perception, sensory, quality of life, and depression. The eligible participants were&#xD;
      recruited and assigned into two groups: ADL home program and control group who received&#xD;
      traditional rehabilitation in hospital. The primary outcome measures were the Canadian&#xD;
      Occupational Performance Measure, the Barthel Index-based Supplementary Scales, the Frenchay&#xD;
      Activities Index, and ADL domain of the Stroke Impact Scale. The secondary outcome measures&#xD;
      were the Fugl-Meyer Assessment, the Mini Mental State Examination, the Test of Visual&#xD;
      Perceptual Skills-Third Edition, and the Center of Epidemiological Study-Depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2018</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of the Canadian Occupational Performance Measure</measure>
    <time_frame>6 months</time_frame>
    <description>The Canadian Occupational Performance Measure assesses occupational performance. The total score ranges from 1-10. A higher score indicates better occupational performance. Changes of occupational performance will be assessed at the 6 weeks, 12 weeks, and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of the Barthel Index-based Supplementary Scales</measure>
    <time_frame>6 months</time_frame>
    <description>The Barthel Index-based Supplementary Scales assesses basic activities of daily living. The total score range from 0-58. A higher score indicates better basic activities of daily living. Changes of basic activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of the Frenchay Activities Index</measure>
    <time_frame>6 months</time_frame>
    <description>The Frenchay Activities Index assesses instrumental activities of daily living. The total score range from 0-45. A higher score indicates better instrumental activities of daily living. Changes of instrumental activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of the ADL domain of the Stroke Impact Scale</measure>
    <time_frame>6 months</time_frame>
    <description>The ADL domain of the Stroke Impact Scale assess difficulty in performing activities of daily living. The domain score range from 10-50. A higher score indicates less difficulty in performing activities of daily living. Changes of difficulty in performing activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of the Fugl-Meyer Assessment</measure>
    <time_frame>6 months</time_frame>
    <description>The Fugl-Meyer Assessment assesses ability of motor control. The total score range from 0-226. A higher score indicates better ability of motor control. Changes of ability of motor control will be assessed at the 6 weeks, 12 weeks, and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of the Mini Mental State Examination</measure>
    <time_frame>6 months</time_frame>
    <description>The Mini Mental State Examination assesses general cognitive ability. The total score range from 0-30. A higher score indicates better general cognitive ability. Changes of general cognitive ability will be assessed at the 6 weeks, 12 weeks, and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of the Test of Visual Perceptual Skills-Third Edition</measure>
    <time_frame>6 months</time_frame>
    <description>The Test of Visual Perceptual Skills-Third Edition assesses visual perception. The total score range from 0-112. A higher score indicates better visual perception. Changes of visual perception will be assessed at the 6 weeks, 12 weeks, and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of the Center of Epidemiological Study-Depression</measure>
    <time_frame>6 months</time_frame>
    <description>The Center of Epidemiological Study-Depression assesses depression conditions. The total score range from 0-60. A higher score indicates more serious depression conditions. Changes of depression conditions will be assessed at the 6 weeks, 12 weeks, and 6 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ADL training program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receive rehabilitation program in the hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Domiciliary care - Activities of Daily Living</intervention_name>
    <description>Home-based ADL training.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of stroke&#xD;
&#xD;
          -  Aged &gt; 20 years&#xD;
&#xD;
          -  Score 2-4 of the modified Rankin Scale&#xD;
&#xD;
          -  Capability of following instructions&#xD;
&#xD;
          -  Willing to participants to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnoses of dementia and Parkinson's disease&#xD;
&#xD;
          -  Physical limitations because of orthopedics diseases&#xD;
&#xD;
          -  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>Der-Sheng Han, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <state>Zhongzheng District</state>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03828851
org study id: 201712067RIND
nct id: NCT03828851
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to investigate the effects of the Domiciliary care- Activities
      of Daily Living program on activities of daily living (ADL), motor, cognition, perception,
      sensory, quality of life, and depression for patients with stroke.
Administering ADL and recovery of ADL functions are the primary efficacy indicators in
      long-term care and the main treatment goals in rehabilitation for patients with stroke.
      Residential rehabilitation is a direct way to observe patients' living environment and
      provides feasible ADL treatment plans for patients with stroke living at home or in the
      community. The purpose of this study was to investigate the effects of the Domiciliary care-
      Activities of Daily Living program on activities of daily living, motor, cognition,
      perception, sensory, quality of life, and depression. The eligible participants were
      recruited and assigned into two groups: ADL home program and control group who received
      traditional rehabilitation in hospital. The primary outcome measures were the Canadian
      Occupational Performance Measure, the Barthel Index-based Supplementary Scales, the Frenchay
      Activities Index, and ADL domain of the Stroke Impact Scale. The secondary outcome measures
      were the Fugl-Meyer Assessment, the Mini Mental State Examination, the Test of Visual
      Perceptual Skills-Third Edition, and the Center of Epidemiological Study-Depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes of the Canadian Occupational Performance Measure
time frame: 6 months
description: The Canadian Occupational Performance Measure assesses occupational performance. The total score ranges from 1-10. A higher score indicates better occupational performance. Changes of occupational performance will be assessed at the 6 weeks, 12 weeks, and 6 months.
measure: Changes of the Barthel Index-based Supplementary Scales
time frame: 6 months
description: The Barthel Index-based Supplementary Scales assesses basic activities of daily living. The total score range from 0-58. A higher score indicates better basic activities of daily living. Changes of basic activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.
measure: Changes of the Frenchay Activities Index
time frame: 6 months
description: The Frenchay Activities Index assesses instrumental activities of daily living. The total score range from 0-45. A higher score indicates better instrumental activities of daily living. Changes of instrumental activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.
measure: Changes of the ADL domain of the Stroke Impact Scale
time frame: 6 months
description: The ADL domain of the Stroke Impact Scale assess difficulty in performing activities of daily living. The domain score range from 10-50. A higher score indicates less difficulty in performing activities of daily living. Changes of difficulty in performing activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.
measure: Changes of the Fugl-Meyer Assessment
time frame: 6 months
description: The Fugl-Meyer Assessment assesses ability of motor control. The total score range from 0-226. A higher score indicates better ability of motor control. Changes of ability of motor control will be assessed at the 6 weeks, 12 weeks, and 6 months.
measure: Changes of the Mini Mental State Examination
time frame: 6 months
description: The Mini Mental State Examination assesses general cognitive ability. The total score range from 0-30. A higher score indicates better general cognitive ability. Changes of general cognitive ability will be assessed at the 6 weeks, 12 weeks, and 6 months.
measure: Changes of the Test of Visual Perceptual Skills-Third Edition
time frame: 6 months
description: The Test of Visual Perceptual Skills-Third Edition assesses visual perception. The total score range from 0-112. A higher score indicates better visual perception. Changes of visual perception will be assessed at the 6 weeks, 12 weeks, and 6 months.
measure: Changes of the Center of Epidemiological Study-Depression
time frame: 6 months
description: The Center of Epidemiological Study-Depression assesses depression conditions. The total score range from 0-60. A higher score indicates more serious depression conditions. Changes of depression conditions will be assessed at the 6 weeks, 12 weeks, and 6 months.
arm group label: Experimental group
arm group type: Experimental
description: ADL training program.
arm group label: Control group
arm group type: No Intervention
description: Receive rehabilitation program in the hospital.
intervention type: Other
intervention name: Domiciliary care - Activities of Daily Living
description: Home-based ADL training.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: No
last name: Der-Sheng Han, Doctor
role: Study Chair
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke