<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/NCT03284580</url>
  </required_header>
  <id_info>
    <org_study_id>Rehab in carers of post-stroke</org_study_id>
    <nct_id>NCT03284580</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Home-based Ergonomic Intervention Program in Caregivers of Chronic Post-stroke Patients</brief_title>
  <official_title>Effectiveness of a Home-based Ergonomic Intervention Program on Overall Quality of Life, Health Satisfaction, and Home Ergonomics in Caregivers of Chronic Post-stroke Patients: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</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 objective of the present study is to evaluate the effectiveness of two home-based&#xD;
      ergonomic intervention programs compared to a control group on the quality of life of&#xD;
      caregivers of post-stroke patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is a neurological pathology that can cause functional problems and an impairment to&#xD;
      perform activities of daily living at home.&#xD;
&#xD;
      For this reason, these patients need the support of a caregiver. Caregivers of post-stroke&#xD;
      patients often have also problems with their quality of life because of the care that they&#xD;
      must provide. These problems appear mainly during the support tasks in the activities&#xD;
      performed at the patient's home.&#xD;
&#xD;
      The objective of the present study is to evaluate the effectiveness of two home-based&#xD;
      ergonomic intervention programs compared to a control group on the quality of life of&#xD;
      caregivers of post-stroke patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2017</start_date>
  <completion_date type="Actual">August 20, 2017</completion_date>
  <primary_completion_date type="Actual">August 9, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from WhoQol-Bref at 8 weeks</measure>
    <time_frame>Eight weeks</time_frame>
    <description>This test measures quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from WhoQol-Bref at 16 weeks</measure>
    <time_frame>Sixteen weeks</time_frame>
    <description>This test measures quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from ergonomic evaluation of the domestic environment at 8 weeks</measure>
    <time_frame>Eight weeks</time_frame>
    <description>This measurement evaluates if domestic environment is ergonomic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from ergonomic evaluation of the domestic environment at 16 weeks</measure>
    <time_frame>Sixteen weeks</time_frame>
    <description>This measurement evaluates if domestic environment is ergonomic</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Stroke</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Ergonomic intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ergonomic intervention program at home for caregivers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postural + kinesiotherapy intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A postural + kinesiotherapy intervention program at home for caregivers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control or conservative group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A conservative intervention by general information for caregivers</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ergonomic intervention</intervention_name>
    <description>An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.</description>
    <arm_group_label>Ergonomic intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postural plus kinesiotherapy intervention program</intervention_name>
    <description>An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.</description>
    <arm_group_label>Postural + kinesiotherapy intervention group</arm_group_label>
    <other_name>A postural plus kinesiotherapy intervention program, including excercises for caregivers</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control or conservative intervention</intervention_name>
    <description>A control or conservative intervention, including general information about stroke disease for the caregivers of these patients</description>
    <arm_group_label>Control or conservative group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being caregivers of post-stroke patients&#xD;
&#xD;
          -  Being over 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being caregiver of patients with other neurological patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>José Manuel Pérez Mármol</name>
      <address>
        <city>Córdoba</city>
        <zip>18007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>José Manuel Pérez Mármol</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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/NCT03284580
org study id: Rehab in carers of post-stroke
nct id: NCT03284580
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of the present study is to evaluate the effectiveness of two home-based
      ergonomic intervention programs compared to a control group on the quality of life of
      caregivers of post-stroke patients
Stroke is a neurological pathology that can cause functional problems and an impairment to
      perform activities of daily living at home.

      For this reason, these patients need the support of a caregiver. Caregivers of post-stroke
      patients often have also problems with their quality of life because of the care that they
      must provide. These problems appear mainly during the support tasks in the activities
      performed at the patient's home.

      The objective of the present study is to evaluate the effectiveness of two home-based
      ergonomic intervention programs compared to a control group on the quality of life of
      caregivers of post-stroke patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from WhoQol-Bref at 8 weeks
time frame: Eight weeks
description: This test measures quality of life
measure: Change from WhoQol-Bref at 16 weeks
time frame: Sixteen weeks
description: This test measures quality of life
measure: Change from ergonomic evaluation of the domestic environment at 8 weeks
time frame: Eight weeks
description: This measurement evaluates if domestic environment is ergonomic
measure: Change from ergonomic evaluation of the domestic environment at 16 weeks
time frame: Sixteen weeks
description: This measurement evaluates if domestic environment is ergonomic
arm group label: Ergonomic intervention group
arm group type: Experimental
description: Ergonomic intervention program at home for caregivers
arm group label: Postural + kinesiotherapy intervention group
arm group type: Experimental
description: A postural + kinesiotherapy intervention program at home for caregivers
arm group label: Control or conservative group
arm group type: Other
description: A conservative intervention by general information for caregivers
intervention type: Other
intervention name: Ergonomic intervention
description: An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
arm group label: Ergonomic intervention group
intervention type: Other
intervention name: Postural plus kinesiotherapy intervention program
description: An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
arm group label: Postural + kinesiotherapy intervention group
other name: A postural plus kinesiotherapy intervention program, including excercises for caregivers
intervention type: Other
intervention name: Control or conservative intervention
description: A control or conservative intervention, including general information about stroke disease for the caregivers of these patients
arm group label: Control or conservative group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: José Manuel Pérez Mármol
investigator title: Principal Investigator
mesh term: Stroke