<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/NCT03282734</url>
  </required_header>
  <id_info>
    <org_study_id>2017-07-072</org_study_id>
    <nct_id>NCT03282734</nct_id>
  </id_info>
  <brief_title>Home-based Exercise Program With Smart Rehabilitation System</brief_title>
  <acronym>Smart-Rehab</acronym>
  <official_title>Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</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 lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation&#xD;
      therapies have been provided to improve the balance and gait function in stroke patients.&#xD;
      However, most rehabilitation therapies are performed in only hospitals, in spite of the&#xD;
      difficulty of moving from home to hospitals for stroke patients. Home-based smart&#xD;
      rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training&#xD;
      program to stroke patients in their home. This study aims to investigate the effects of the&#xD;
      home-based exercise program with smart rehabilitation system on balance and gait functions in&#xD;
      stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total 100 patients with stroke will be divided into each the intervention group and the&#xD;
      control group. The intervention group will be provided the home-based smart rehabilitation&#xD;
      system for 4 weeks, and the control group will be educated the conventional home&#xD;
      rehabilitation exercise at once. The immediate effects of the home-based smart rehabilitation&#xD;
      system on the balance and gait function will be assessed at 4 weeks after exercise and the&#xD;
      long-term carry-over effects will be also assesed at 4 weeks after cessation of exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Timed Up and Go test</measure>
    <time_frame>Change from baseline Timed Up and Go test at 4 weeks</time_frame>
    <description>Assessment of balance and gait function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tinetti Performance Oriented Mobility Assessment</measure>
    <time_frame>Change from baseline Timed Up and Go test at 4 weeks</time_frame>
    <description>Assessment of balance and gait function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg Balance scale</measure>
    <time_frame>Change from baseline Timed Up and Go test at 4 weeks</time_frame>
    <description>Assessment of balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Korean-Geriatric Depression Scale- Short Form</measure>
    <time_frame>Change from baseline Timed Up and Go test at 4 weeks</time_frame>
    <description>Assessment of mood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>Change from baseline Timed Up and Go test at 4 weeks</time_frame>
    <description>Assessment of quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls Efficacy Scale</measure>
    <time_frame>Change from baseline Timed Up and Go test at 4 weeks</time_frame>
    <description>Assessment of fall risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Korean version of Physical Activity Scale for the Elderly</measure>
    <time_frame>Change from baseline Timed Up and Go test at 4 weeks</time_frame>
    <description>Assessment of physical activity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>The smart rehab group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional home rehabilitation exercise education for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)</intervention_name>
    <description>Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks</description>
    <arm_group_label>The smart rehab group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional home rehabilitation exercise</intervention_name>
    <description>Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks</description>
    <arm_group_label>The control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult stroke patients (more than 18 years old)&#xD;
&#xD;
          -  less than 6 months after stroke onset&#xD;
&#xD;
          -  discharged to home or the plan to discharge to home less than 3 days&#xD;
&#xD;
          -  independent ambulatory function on even level (4 or more than 4 in Functional&#xD;
             Ambulatory Category)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Advanced liver, kidney, cardiac, or pulmonary disease&#xD;
&#xD;
          -  A terminal medical diagnosis consistent with survival &lt; 1 year)&#xD;
&#xD;
          -  Pre-existing and active major neurological disease&#xD;
&#xD;
          -  Pre-existing and active major psychiatric disease&#xD;
&#xD;
          -  Severe language disorders&#xD;
&#xD;
          -  Severe cognitive disorders (10 or less than 10 in K-MMSE)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Won Hyuk Chang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <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/NCT03282734
org study id: 2017-07-072
nct id: NCT03282734
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation
      therapies have been provided to improve the balance and gait function in stroke patients.
      However, most rehabilitation therapies are performed in only hospitals, in spite of the
      difficulty of moving from home to hospitals for stroke patients. Home-based smart
      rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training
      program to stroke patients in their home. This study aims to investigate the effects of the
      home-based exercise program with smart rehabilitation system on balance and gait functions in
      stroke patients.
The total 100 patients with stroke will be divided into each the intervention group and the
      control group. The intervention group will be provided the home-based smart rehabilitation
      system for 4 weeks, and the control group will be educated the conventional home
      rehabilitation exercise at once. The immediate effects of the home-based smart rehabilitation
      system on the balance and gait function will be assessed at 4 weeks after exercise and the
      long-term carry-over effects will be also assesed at 4 weeks after cessation of exercise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Timed Up and Go test
time frame: Change from baseline Timed Up and Go test at 4 weeks
description: Assessment of balance and gait function
measure: Tinetti Performance Oriented Mobility Assessment
time frame: Change from baseline Timed Up and Go test at 4 weeks
description: Assessment of balance and gait function
measure: Berg Balance scale
time frame: Change from baseline Timed Up and Go test at 4 weeks
description: Assessment of balance
measure: Korean-Geriatric Depression Scale- Short Form
time frame: Change from baseline Timed Up and Go test at 4 weeks
description: Assessment of mood
measure: EQ-5D
time frame: Change from baseline Timed Up and Go test at 4 weeks
description: Assessment of quality of life
measure: Falls Efficacy Scale
time frame: Change from baseline Timed Up and Go test at 4 weeks
description: Assessment of fall risk
measure: Korean version of Physical Activity Scale for the Elderly
time frame: Change from baseline Timed Up and Go test at 4 weeks
description: Assessment of physical activity
arm group label: The smart rehab group
arm group type: Experimental
description: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks
arm group label: The control group
arm group type: Active Comparator
description: Conventional home rehabilitation exercise education for 4 weeks
intervention type: Other
intervention name: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)
description: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks
arm group label: The smart rehab group
intervention type: Other
intervention name: Conventional home rehabilitation exercise
description: Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks
arm group label: The control group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Won Hyuk Chang
investigator title: Associate Professor
mesh term: Stroke
sharing ipd: No