<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/NCT01693341</url>
  </required_header>
  <id_info>
    <org_study_id>CT-tsaiac1943</org_study_id>
    <nct_id>NCT01693341</nct_id>
  </id_info>
  <brief_title>A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients</brief_title>
  <official_title>Caregiver-mediated Intervention in Home-living Chronic Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Asia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the feasibility of improving stroke patients' physical functional recovery and&#xD;
      social participation through improving caregiver's care capability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the hospital, most rehabilitation units are like sheltered workshops and the therapists&#xD;
      work with stroke patients in well-designed, but non-home-like, environment to improve the&#xD;
      stroke patient's functional ability. After returning home, stroke patients face new&#xD;
      challenges and also need to assume more responsibility for daily activities. Without&#xD;
      continuing rehabilitation training or proper support, the patients can easily fall into a&#xD;
      sedentary lifestyle and lead to declines in functional ability.However, providing home-based&#xD;
      exercise by therapists directly would increase the health care cost and may not be practical&#xD;
      for chronic stroke patients. Hence, the objective of the present study was to determine&#xD;
      whether a caregiver-mediated, home-based intervention program is effective for improving&#xD;
      stroke patients' functional ability and social participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stroke Impact Scale</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change from baseline in Stroke Impact Scale at 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>10-meter walking speed</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg balance scale</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change from baseline in berg balance scale score at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-min walking distance</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change from baseline in 6-min walking distance at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bathel index score</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change from baseline in Bathel index score at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lawton Instrumental Activities of Daily Living scale (IADL)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment Scale</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Caregiver Burden Scale</measure>
    <time_frame>baseline and 12 weeks</time_frame>
    <description>Change from baseline in Caregiver Burden Scale at 12 weeks</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Care-giver mediated training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard-care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Maintain the inherent standard-care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Care-giver mediated training</intervention_name>
    <description>A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.</description>
    <arm_group_label>Care-giver mediated training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)&#xD;
&#xD;
          2. No longer undertaking active rehabilitation program(defined as ≤2 times/wk&#xD;
             rehabilitation activities)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Recurring strokes&#xD;
&#xD;
          2. Mental or cognitive impairment&#xD;
&#xD;
          3. Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid&#xD;
             arthritis or acute myocardial infarction)&#xD;
&#xD;
          4. Caregiver with mental/behavioral disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan. C Tsai, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Asia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80288</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Galvin R, Cusack T, O'Grady E, Murphy TB, Stokes E. Family-mediated exercise intervention (FAME): evaluation of a novel form of exercise delivery after stroke. Stroke. 2011 Mar;42(3):681-6. doi: 10.1161/STROKEAHA.110.594689. Epub 2011 Jan 13.</citation>
    <PMID>21233462</PMID>
  </reference>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>March 28, 2013</last_update_submitted>
  <last_update_submitted_qc>March 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asia University</investigator_affiliation>
    <investigator_full_name>Alan C. Tsai, Ph. D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Chronic stroke patients</keyword>
  <keyword>Stroke rehabilitation</keyword>
  <keyword>Caregiver</keyword>
  <keyword>Caregiver-mediated intervention</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/NCT01693341
org study id: CT-tsaiac1943
nct id: NCT01693341
lead sponsor: 
collaborator: 
has dmc: Yes
To examine the feasibility of improving stroke patients' physical functional recovery and
      social participation through improving caregiver's care capability.
In the hospital, most rehabilitation units are like sheltered workshops and the therapists
      work with stroke patients in well-designed, but non-home-like, environment to improve the
      stroke patient's functional ability. After returning home, stroke patients face new
      challenges and also need to assume more responsibility for daily activities. Without
      continuing rehabilitation training or proper support, the patients can easily fall into a
      sedentary lifestyle and lead to declines in functional ability.However, providing home-based
      exercise by therapists directly would increase the health care cost and may not be practical
      for chronic stroke patients. Hence, the objective of the present study was to determine
      whether a caregiver-mediated, home-based intervention program is effective for improving
      stroke patients' functional ability and social participation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Stroke Impact Scale
time frame: Baseline and 12 weeks
description: Change from baseline in Stroke Impact Scale at 12 weeks
measure: 10-meter walking speed
time frame: Baseline and 12 weeks
description: Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks
measure: Berg balance scale
time frame: Baseline and 12 weeks
description: Change from baseline in berg balance scale score at 12 weeks
measure: 6-min walking distance
time frame: Baseline and 12 weeks
description: Change from baseline in 6-min walking distance at 12 weeks
measure: Bathel index score
time frame: Baseline and 12 weeks
description: Change from baseline in Bathel index score at 12 weeks
measure: Lawton Instrumental Activities of Daily Living scale (IADL)
time frame: Baseline and 12 weeks
description: Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks
measure: Fugl-Meyer Assessment Scale
time frame: Baseline and 12 weeks
description: Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks
measure: Center for Epidemiologic Studies Depression Scale
time frame: Baseline and 12 weeks
description: Change from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks
measure: Caregiver Burden Scale
time frame: baseline and 12 weeks
description: Change from baseline in Caregiver Burden Scale at 12 weeks
arm group label: Care-giver mediated training
arm group type: Active Comparator
description: Each patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need.
arm group label: Standard-care
arm group type: No Intervention
description: Maintain the inherent standard-care
intervention type: Other
intervention name: Care-giver mediated training
description: A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.
arm group label: Care-giver mediated training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Alan. C Tsai, PhD
role: Study Chair
affiliation: Asia University
facility: 
country: Taiwan
citation: Galvin R, Cusack T, O'Grady E, Murphy TB, Stokes E. Family-mediated exercise intervention (FAME): evaluation of a novel form of exercise delivery after stroke. Stroke. 2011 Mar;42(3):681-6. doi: 10.1161/STROKEAHA.110.594689. Epub 2011 Jan 13.
PMID: 21233462
responsible party type: Principal Investigator
investigator affiliation: Asia University
investigator full name: Alan C. Tsai, Ph. D.
investigator title: Professor
mesh term: Stroke