xml: <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/NCT05993598</url>
    </required_header>
    <id_info>
      <org_study_id>BURAKEMİRHAN</org_study_id>
      <nct_id>NCT05993598</nct_id>
    </id_info>
    <brief_title>The Effect of Hippotherapy Applied on Different Seating Surfaces in Children With Special Needs</brief_title>
    <official_title>The Effect of Hippotherapy Applied on Different Sitting Surfaces on Sitting Balance and Walking Speed in Children With Special Needs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medipol University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medipol University Hospital</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 effect of hippotherapy, which will be applied to children with special needs in a single&#xD;
        session, on sitting balance and walking speed under the supervision of a physiotherapist was&#xD;
        investigated. 30 randomly selected children with special needs between the ages of 3-18 who&#xD;
        were referred to the Gebze Equestrian Training Center were included in the study. The&#xD;
        children were randomly divided into 3 groups: 10 in the saddle, 10 naked (direct contact with&#xD;
        the horse), and 10 in the hippotherapy group, in which a cloth of different texture was&#xD;
        placed on the horse. Each group did a 30-minute hippotherapy session in the manege area.&#xD;
        Before the application, the sitting balance of the children was evaluated by playing the&#xD;
        Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was&#xD;
        applied for walking speed. These assessments were repeated after the 30-minute session. It&#xD;
        was checked whether the application had an effect on balance and walking speed. Comparisons&#xD;
        between the groups were made and it was examined which application was more effective on&#xD;
        balance and walking speed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 17, 2023</start_date>
    <completion_date type="Actual">May 10, 2023</completion_date>
    <primary_completion_date type="Actual">February 17, 2023</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>BeCure Balance Evaluation System</measure>
      <time_frame>11 weeks</time_frame>
      <description>BeCure Balance Assessment System protocol; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the body center of gravity during balancing by sitting on the board for 30 seconds with eyes open, with images.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ten(10) Meter Walking Test(sec)</measure>
      <time_frame>11 weeks</time_frame>
      <description>In this test, the person is asked to walk at their own normal pace in a pre-measured 10 meter area (if using walking aid, it will be done with it). The time starts when the person's foot is on the starting line and ends when they cross the finish line. Two measurements are made and the best value is recorded in meters per second (m/s).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gross Motor Function Classification System (GMFCS)</measure>
      <time_frame>11 weeks</time_frame>
      <description>It was used to evaluate the motor functions of participants with a diagnosis of cerebral palsy. It is a standardized method that classifies motor function differences in sitting and walking at 5 levels. If we examine the 5 levels; Level I walks without restrictions; Level II walks with restrictions; Level III walks using hand-held mobility devices; Level IV, independent self-mobility is limited and may use a motorized mobility vehicle; Level V is transported in a manual wheelchair.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Special Needs Children</condition>
    <arm_group>
      <arm_group_label>Group 1 (Saddled)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (Saddleless, direct contact with horse)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3 (Different tissue to be put on the saddle)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Bubbled nylon (pat-to-pat) was used as a different texture. Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>hippotherapy</intervention_name>
      <description>Evaluation parameters were applied to 30 children with special needs at the beginning of the session. After the evaluation, each group was given a 30-minute hippotherapy session in the manege area. During the practice, the child simply sat on the horse. The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand. Immediately after the 30-minute application, the initial evaluations were made again. As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.</description>
      <arm_group_label>Group 1 (Saddled)</arm_group_label>
      <arm_group_label>Group 2 (Saddleless, direct contact with horse)</arm_group_label>
      <arm_group_label>Group 3 (Different tissue to be put on the saddle)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having a child with special needs between the ages of 3-18,&#xD;
  &#xD;
            -  Children with a diagnosis of Cerebral Palsy (CP) have a level of 1 and 2 according to&#xD;
               the Gross Motor Function Classification System,&#xD;
  &#xD;
            -  Ability to understand simple commands,&#xD;
  &#xD;
            -  Ability to sit unaided for at least 10 seconds,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of clinical conditions that may pose an obstacle&#xD;
  &#xD;
            -  Lack of cooperation&#xD;
  &#xD;
            -  Presence in another study performed at the same time as the study&#xD;
  &#xD;
            -  Lack of family approval.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ebru SEVER, Lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Department of Physiotherapy &amp; Rehabilitation</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Gebze Municipality Equestrian Training Center</name>
        <address>
          <city>Kocaeli</city>
          <state>Gebze</state>
          <zip>41400</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
      <investigator_full_name>Ebru Sever</investigator_full_name>
      <investigator_title>PhD, PT</investigator_title>
    </responsible_party>
    <keyword>hippotherapy</keyword>
    <keyword>sitting balance</keyword>
    <keyword>child with special needs</keyword>
    <keyword>walking speed</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993598
  org study id: BURAKEMİRHAN
  nct id: NCT05993598
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The effect of hippotherapy, which will be applied to children with special needs in a single
        session, on sitting balance and walking speed under the supervision of a physiotherapist was
        investigated. 30 randomly selected children with special needs between the ages of 3-18 who
        were referred to the Gebze Equestrian Training Center were included in the study. The
        children were randomly divided into 3 groups: 10 in the saddle, 10 naked (direct contact with
        the horse), and 10 in the hippotherapy group, in which a cloth of different texture was
        placed on the horse. Each group did a 30-minute hippotherapy session in the manege area.
        Before the application, the sitting balance of the children was evaluated by playing the
        Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was
        applied for walking speed. These assessments were repeated after the 30-minute session. It
        was checked whether the application had an effect on balance and walking speed. Comparisons
        between the groups were made and it was examined which application was more effective on
        balance and walking speed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: BeCure Balance Evaluation System
  time frame: 11 weeks
  description: BeCure Balance Assessment System protocol; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the body center of gravity during balancing by sitting on the board for 30 seconds with eyes open, with images.
  measure: Ten(10) Meter Walking Test(sec)
  time frame: 11 weeks
  description: In this test, the person is asked to walk at their own normal pace in a pre-measured 10 meter area (if using walking aid, it will be done with it). The time starts when the person's foot is on the starting line and ends when they cross the finish line. Two measurements are made and the best value is recorded in meters per second (m/s).
  measure: Gross Motor Function Classification System (GMFCS)
  time frame: 11 weeks
  description: It was used to evaluate the motor functions of participants with a diagnosis of cerebral palsy. It is a standardized method that classifies motor function differences in sitting and walking at 5 levels. If we examine the 5 levels; Level I walks without restrictions; Level II walks with restrictions; Level III walks using hand-held mobility devices; Level IV, independent self-mobility is limited and may use a motorized mobility vehicle; Level V is transported in a manual wheelchair.
  arm group label: Group 1 (Saddled)
  arm group type: Experimental
  description: Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.
  arm group label: Group 2 (Saddleless, direct contact with horse)
  arm group type: Experimental
  description: Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.
  arm group label: Group 3 (Different tissue to be put on the saddle)
  arm group type: Experimental
  description: Bubbled nylon (pat-to-pat) was used as a different texture. Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session.
  intervention type: Other
  intervention name: hippotherapy
  description: Evaluation parameters were applied to 30 children with special needs at the beginning of the session. After the evaluation, each group was given a 30-minute hippotherapy session in the manege area. During the practice, the child simply sat on the horse. The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand. Immediately after the 30-minute application, the initial evaluations were made again. As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.
  arm group label: Group 1 (Saddled)
  arm group label: Group 2 (Saddleless, direct contact with horse)
  arm group label: Group 3 (Different tissue to be put on the saddle)
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Ebru SEVER, Lecturer
  role: Study Director
  affiliation: Department of Physiotherapy & Rehabilitation
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medipol University Hospital
  investigator full name: Ebru Sever
  investigator title: PhD, PT
  sharing ipd: No