<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/NCT04465006</url>
  </required_header>
  <id_info>
    <org_study_id>09.2018.425</org_study_id>
    <nct_id>NCT04465006</nct_id>
  </id_info>
  <brief_title>Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients</brief_title>
  <official_title>Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</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 aim of our study is to investigate the effects of hippotherapy simulator exercises in&#xD;
      addition to the conventional rehabilitation program on the balance, postural control,&#xD;
      mobility, functional capacity, and independence levels of stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty-six 18- 65 years of patients with stroke were included in the study. Patients were&#xD;
      divided into two groups as hippotherapy simulator group (HSG) (n = 13) and conventional&#xD;
      exercise group (CEG) (n = 13). Patients were evaluated with Berg Balance Scale (BBS) for&#xD;
      balance, Postural Assessment Scale for Stroke (PASS) for postural control, Rivermead Mobility&#xD;
      Index (RMI), and Time Up- Go Test (TUG) for mobility, 2min. Walking Test (2mWT) for&#xD;
      functional capacity and Barthel Index (BI) for the level of independence respectively before&#xD;
      and after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</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>
    <intervention_model_description>One group received hippotherapy exercise, while the other group received conventional exercise.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>Day 0 - Day 45</time_frame>
    <description>The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postural Assessment Scale for Stroke</measure>
    <time_frame>Day 0 - Day 45</time_frame>
    <description>It measures the ability of an individual with stroke to maintain stable postures and equilibrium during positional changes. It consists of a 4-point scale where the items are scored from 0 to 3, and the total scoring ranges from 0 to 36</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rivermead Mobility Index</measure>
    <time_frame>Day 0 - Day 45</time_frame>
    <description>The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Up and Go Test</measure>
    <time_frame>Day 0 - Day 45</time_frame>
    <description>The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2 Minute Walk Test</measure>
    <time_frame>Day 0 - Day 45</time_frame>
    <description>2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barthel Index</measure>
    <time_frame>Day 0 - Day 45</time_frame>
    <description>The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Hippotherapy Simulator Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Getting a diagnosis of stroke by a specialist physician, Being between the ages of 18-65, Having a stroke history of 3- 36 months, To be able to sit without support while both soles are in contact with the floor, To be able to walk independently with or without using walking aid, To be able to understand and follow audio and visual warnings, Scoring 24 points or more from the Mini Mental State Exam.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Getting a diagnosis of stroke by a specialist physician, Being between the ages of 18-65, Having a stroke history of 3- 36 months, To be able to sit without support while both soles are in contact with the floor, To be able to walk independently with or without using walking aid, To be able to understand and follow audio and visual warnings, Scoring 24 points or more from the Mini Mental State Exam.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hippotherapy Simulator</intervention_name>
    <description>Patients in the hippotherapy simulator group received 30 sessions of treatment for 6 weeks, 5 days a week and 1 hour a day. 45 minutes of Neurodevelopmental treatment exercises and 15 minutes of hippotherapy simulation exercise program were applied to the participants in this group.</description>
    <arm_group_label>Hippotherapy Simulator Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Exercise</intervention_name>
    <description>Patients in the conventionnal exercise group received 30 sessions of treatment for 6 weeks, 5 days a week and 1 hour a day. 60 minutes of Neurodevelopmental treatment exercises were applied to the participants in this group.</description>
    <arm_group_label>Conventional Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Getting a diagnosis of stroke by a specialist physician,&#xD;
&#xD;
          -  Being between the ages of 18-65,&#xD;
&#xD;
          -  Having a stroke history of 3- 36 months,&#xD;
&#xD;
          -  To be able to sit without support while both soles are in contact with the floor,&#xD;
&#xD;
          -  To be able to walk independently with or without using a walking aid,&#xD;
&#xD;
          -  To be able to understand and follow audio and visual warnings,&#xD;
&#xD;
          -  Scoring 24 points or more from the Mini-Mental State Exam.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple stroke stories,&#xD;
&#xD;
          -  Hemorrhagic type stroke history,&#xD;
&#xD;
          -  Those with a history of falling in the past 1 year,&#xD;
&#xD;
          -  Those with a history of epilepsy,&#xD;
&#xD;
          -  Uncontrolled history of Hypertension and Diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zubeyir Sarı, Assoc Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Physiotherapy and Rehabilitation - Marmara University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergen Ozturk, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physiotherapy and Rehabilitation - Marmara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Private Ersoy Hospital</name>
      <address>
        <city>Sultanbeyli</city>
        <state>Istanbul</state>
        <zip>34920</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016 Sep 1;94(9):634-634A. doi: 10.2471/BLT.16.181636. No abstract available.</citation>
    <PMID>27708464</PMID>
  </reference>
  <reference>
    <citation>Nedeltchev K, der Maur TA, Georgiadis D, Arnold M, Caso V, Mattle HP, Schroth G, Remonda L, Sturzenegger M, Fischer U, Baumgartner RW. Ischaemic stroke in young adults: predictors of outcome and recurrence. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):191-5. doi: 10.1136/jnnp.2004.040543.</citation>
    <PMID>15654030</PMID>
  </reference>
  <reference>
    <citation>Huang CY, Lin GH, Huang YJ, Song CY, Lee YC, How MJ, Chen YM, Hsueh IP, Chen MH, Hsieh CL. Improving the utility of the Brunnstrom recovery stages in patients with stroke: Validation and quantification. Medicine (Baltimore). 2016 Aug;95(31):e4508. doi: 10.1097/MD.0000000000004508.</citation>
    <PMID>27495103</PMID>
  </reference>
  <results_reference>
    <citation>Kim S, Yuk GC, Gak H. Effects of the horse riding simulator and ball exercises on balance of the elderly. J Phys Ther Sci. 2013 Nov;25(11):1425-8. doi: 10.1589/jpts.25.1425. Epub 2013 Dec 11.</citation>
    <PMID>24396203</PMID>
  </results_reference>
  <results_reference>
    <citation>Ciou SH, Hwang YS, Chen CC, Chen SC, Chou SW, Chen YL. Balance training using an interactive game to enhance the use of the affected side after stroke. J Phys Ther Sci. 2015 Dec;27(12):3855-61. doi: 10.1589/jpts.27.3855. Epub 2015 Dec 28.</citation>
    <PMID>26834368</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hippotherapy</keyword>
  <keyword>Cerebrovasculer disorders</keyword>
  <keyword>Stroke Rehabilitation</keyword>
  <keyword>Balance</keyword>
  <keyword>Exercise</keyword>
  <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/NCT04465006
org study id: 09.2018.425
nct id: NCT04465006
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to investigate the effects of hippotherapy simulator exercises in
      addition to the conventional rehabilitation program on the balance, postural control,
      mobility, functional capacity, and independence levels of stroke patients.
Twenty-six 18- 65 years of patients with stroke were included in the study. Patients were
      divided into two groups as hippotherapy simulator group (HSG) (n = 13) and conventional
      exercise group (CEG) (n = 13). Patients were evaluated with Berg Balance Scale (BBS) for
      balance, Postural Assessment Scale for Stroke (PASS) for postural control, Rivermead Mobility
      Index (RMI), and Time Up- Go Test (TUG) for mobility, 2min. Walking Test (2mWT) for
      functional capacity and Barthel Index (BI) for the level of independence respectively before
      and after treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group received hippotherapy exercise, while the other group received conventional exercise.
primary purpose: Treatment
masking: Single (Participant)
measure: Berg Balance Scale
time frame: Day 0 - Day 45
description: The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
measure: Postural Assessment Scale for Stroke
time frame: Day 0 - Day 45
description: It measures the ability of an individual with stroke to maintain stable postures and equilibrium during positional changes. It consists of a 4-point scale where the items are scored from 0 to 3, and the total scoring ranges from 0 to 36
measure: Rivermead Mobility Index
time frame: Day 0 - Day 45
description: The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke.
measure: Timed Up and Go Test
time frame: Day 0 - Day 45
description: The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults.
measure: 2 Minute Walk Test
time frame: Day 0 - Day 45
description: 2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity.
measure: Barthel Index
time frame: Day 0 - Day 45
description: The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
arm group label: Hippotherapy Simulator Group
arm group type: Experimental
description: Getting a diagnosis of stroke by a specialist physician, Being between the ages of 18-65, Having a stroke history of 3- 36 months, To be able to sit without support while both soles are in contact with the floor, To be able to walk independently with or without using walking aid, To be able to understand and follow audio and visual warnings, Scoring 24 points or more from the Mini Mental State Exam.
arm group label: Conventional Exercise Group
arm group type: Experimental
description: Getting a diagnosis of stroke by a specialist physician, Being between the ages of 18-65, Having a stroke history of 3- 36 months, To be able to sit without support while both soles are in contact with the floor, To be able to walk independently with or without using walking aid, To be able to understand and follow audio and visual warnings, Scoring 24 points or more from the Mini Mental State Exam.
intervention type: Other
intervention name: Hippotherapy Simulator
description: Patients in the hippotherapy simulator group received 30 sessions of treatment for 6 weeks, 5 days a week and 1 hour a day. 45 minutes of Neurodevelopmental treatment exercises and 15 minutes of hippotherapy simulation exercise program were applied to the participants in this group.
arm group label: Hippotherapy Simulator Group
intervention type: Other
intervention name: Conventional Exercise
description: Patients in the conventionnal exercise group received 30 sessions of treatment for 6 weeks, 5 days a week and 1 hour a day. 60 minutes of Neurodevelopmental treatment exercises were applied to the participants in this group.
arm group label: Conventional Exercise Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Zubeyir Sarı, Assoc Prof
role: Study Chair
affiliation: Department of Physiotherapy and Rehabilitation - Marmara University
last name: Sergen Ozturk, PT
role: Principal Investigator
affiliation: Department of Physiotherapy and Rehabilitation - Marmara University
facility: 
country: Turkey
citation: Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016 Sep 1;94(9):634-634A. doi: 10.2471/BLT.16.181636. No abstract available.
PMID: 27708464
citation: Nedeltchev K, der Maur TA, Georgiadis D, Arnold M, Caso V, Mattle HP, Schroth G, Remonda L, Sturzenegger M, Fischer U, Baumgartner RW. Ischaemic stroke in young adults: predictors of outcome and recurrence. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):191-5. doi: 10.1136/jnnp.2004.040543.
PMID: 15654030
citation: Huang CY, Lin GH, Huang YJ, Song CY, Lee YC, How MJ, Chen YM, Hsueh IP, Chen MH, Hsieh CL. Improving the utility of the Brunnstrom recovery stages in patients with stroke: Validation and quantification. Medicine (Baltimore). 2016 Aug;95(31):e4508. doi: 10.1097/MD.0000000000004508.
PMID: 27495103
citation: Kim S, Yuk GC, Gak H. Effects of the horse riding simulator and ball exercises on balance of the elderly. J Phys Ther Sci. 2013 Nov;25(11):1425-8. doi: 10.1589/jpts.25.1425. Epub 2013 Dec 11.
PMID: 24396203
citation: Ciou SH, Hwang YS, Chen CC, Chen SC, Chou SW, Chen YL. Balance training using an interactive game to enhance the use of the affected side after stroke. J Phys Ther Sci. 2015 Dec;27(12):3855-61. doi: 10.1589/jpts.27.3855. Epub 2015 Dec 28.
PMID: 26834368
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No