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/NCT06003868</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar72</org_study_id>
      <nct_id>NCT06003868</nct_id>
    </id_info>
    <brief_title>Investigation of the Effect of Hippotherapy Simulator in Children With Spastic Diplegia and Cerebral Palsy</brief_title>
    <official_title>Investigation of the Effect of Hippotherapy Simulator on Balance and Walking in Children With Spastic Diplegia Cerebral Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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 the study is to examine the effect of hippotherapy simulator on trunk control,&#xD;
        balance and gait in children with spastic diplegia cerebral palsy and its relationship with&#xD;
        quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients diagnosed with spastic diplegia cerebral palsy in the study; It will be classified&#xD;
        according to Gross Motor Function Classification System (KMFSS). The Trunk Control&#xD;
        Measurement Scale will be used to assess trunk control. Pediatric Berg Balance Scale will be&#xD;
        used to assess balance. The 1 Minute Walk Test and the Timed Get Up and Go test will be used&#xD;
        to assess walking. The WEEFIM scale will be used to assess quality of life. The study sample&#xD;
        will be divided into two groups. The first group will receive 45 minutes of conventional&#xD;
        physical therapy. In addition to 45 minutes of physical therapy, the other group will receive&#xD;
        15 minutes of hippotherapy simulator. The results will be compared at the beginning and end&#xD;
        of the study.&#xD;
  &#xD;
        Then, individuals will be divided into two groups with a simple randomized method.&#xD;
        Traditional physical therapy will be applied to the control group for 45 minutes, 2 days a&#xD;
        week, for 8 weeks. In addition to traditional physical therapy, 15 minutes of therapy&#xD;
        training with a hippotherapy device will be applied to the experimental group. Evaluation&#xD;
        tests will be repeated at the beginning and end of the study. Pre- and post-intervention data&#xD;
        were statistically analyzed and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 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>
      <intervention_model_description>Exercises with Hippotherapy Simulator: This exercise will be applied to the group for 8 weeks, 2 days a week, as a single session (15 minutes) a day. The patients will be placed on the simulator and the starting position will be taught. They will be warned to maintain the starting position throughout the movements of the simulator. The hippotherapy simulator will be operated almost in the gait pattern of the horse and in the 1st stage of the 3-stage speed level. If the patients have unusual complaints such as dizziness, blackout, chest pain and risk of falling during the application. they will be advised to request to stop the application</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pediatric Berg Balance Scale</measure>
      <time_frame>10 weeks</time_frame>
      <description>Berg Balance Scale was designed for children to evaluate functions in activities of daily living.&#xD;
  version. The scale consists of 14 assessments and each section is scored between 0-4; The highest possible score is 56.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trunk Control Measurement Scale</measure>
      <time_frame>10 weeks</time_frame>
      <description>For this reason, the scale consists of two parts: Static Sitting Balance (SSB) and Dynamic Sitting Balance (DSB). The DSB section also consists of two sub-parameters as selective motion control and dynamic reach. While the static sitting balance subscale evaluates static trunk control during lower and upper extremity movements, the selective motion control subscale evaluates selective trunk movements in three planes (flexion/extension, rotation, and lateral flexion). The dynamic reach subscale evaluates performance during reaching tasks that require active trunk movement. The scale consists of 15 items in total (subscales 5, 7 and 3 items, respectively). Items are scored on a 2, 3, and 4-point ordinal scale and are administered bilaterally when clinically significant. While the total score of the scale varies between 0-58 points, higher scores indicate a better performance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>1 Minute Walk Test</measure>
      <time_frame>10 weeks</time_frame>
      <description>First, the child puts on his own clothes and shoes. He is allowed to use his splints and suitable walking aid. At least 5 minutes before starting the test. He is allowed to rest and then brought to the starting point of the path he will walk. When the command is given, it is said to start walking as fast as possible for 1 minute. It is also reported that he is not allowed to run. The distance is then calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed get up and go test</measure>
      <time_frame>10 weeks</time_frame>
      <description>It is a test used to measure mobility and assesses walking speed, postural control, functional mobility and balance. The Timed Get Up and Go Test measures the time it takes for a person to get up from an arm-supported chair, turn by walking 3 m, and walk back to the chair, then sit down. The time it takes to get up from the chair and sit back on the chair is recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional independence measurement for children (WEEFIM)</measure>
      <time_frame>10 weeks</time_frame>
      <description>It was developed to assess the level of functional independence of children with a physical disability and consists of three main categories and a total of 18 questions. A total of 18 questions under the heading of self-care, mobility and cognitive function categories are scored between 1 and 7. According to this; While performing the function to be evaluated, the child with a physical disability gets 1 point if he/she does it completely with assistance, and 7 points if he/she does it completely independently. The lowest score that the child can get from the scale is 18, and the highest score is 126.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Cerebral Palsy</condition>
    <condition>Balance; Distorted</condition>
    <condition>Walking, Difficulty</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Physiotherapy will be applied for 8 weeks, 2 days a week, as one session per day (45 minutes).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>hippotherapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Physiotherapy will be applied for 8 weeks, 2 days a week, one session a day (45 minutes). In addition, the patients will be placed on the simulator and the starting position will be taught. your simulator They will be warned before and during the application to maintain the starting position throughout their movements.&#xD;
  pattern and will be run in the 1st stage of the 3-stage speed level.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>traditional physiotherapy</intervention_name>
      <description>Stretching for patients with spasticity exercises walking exercises for balance and gait disorders muscle strengthening exercises relaxation exercises</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>hippotherapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>hippotherapy-assisted physiotherapy</intervention_name>
      <description>The patients will be placed on the simulator and the starting position will be taught. your simulator before the application and in order to maintain the starting position throughout their movements.&#xD;
  they will be warned during the applications.. Hippotherapy simulator is almost like walking.&#xD;
  pattern and will be run in the 1st stage of the 3-stage speed level.</description>
      <arm_group_label>hippotherapy group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diplegic Cerebral Palsy between the ages of 4 and 16&#xD;
  &#xD;
            -  Levels 1,2 and 3 according to KMFSS&#xD;
  &#xD;
            -  Have not had botox or surgery in the last 6 months&#xD;
  &#xD;
            -  Able to perceive simple commands&#xD;
  &#xD;
            -  Patients who can sit in the hippotherapy simulator will be included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  With hip dislocation&#xD;
  &#xD;
            -  Those with hearing or visual disabilities&#xD;
  &#xD;
            -  Those who do not want to be involved in the study&#xD;
  &#xD;
            -  Adductor spasticity is stage 3 and above according to the ashworth spasticity scale.&#xD;
  &#xD;
            -  With upper extremity amputation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pelin GÜNEŞ</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>İşbir Hospital</name>
        <address>
          <city>Tuzla</city>
          <state>İstanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Matusiak-Wieczorek E, Dziankowska-Zaborszczyk E, Synder M, Borowski A. The Influence of Hippotherapy on the Body Posture in a Sitting Position among Children with Cerebral Palsy. Int J Environ Res Public Health. 2020 Sep 19;17(18):6846. doi: 10.3390/ijerph17186846.</citation>
      <PMID>32961681</PMID>
    </reference>
    <reference>
      <citation>Hausler M, Heussen N. Protocol for a systematic review and meta-analysis on the effect of hippotherapy and related equine-assisted therapies on motor capabilities in children with cerebral palsy. Syst Rev. 2020 Mar 5;9(1):48. doi: 10.1186/s13643-020-01297-7.</citation>
      <PMID>32138777</PMID>
    </reference>
    <reference>
      <citation>Hyun C, Kim K, Lee S, Ko N, Lee IS, Koh SE. The Short-term Effects of Hippotherapy and Therapeutic Horseback Riding on Spasticity in Children With Cerebral Palsy: A Meta-analysis. Pediatr Phys Ther. 2022 Apr 1;34(2):172-178. doi: 10.1097/PEP.0000000000000880.</citation>
      <PMID>35184078</PMID>
    </reference>
    <reference>
      <citation>Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.</citation>
      <PMID>32086598</PMID>
    </reference>
    <reference>
      <citation>Apolo-Arenas MD, Jeronimo AFA, Cana-Pino A, Fernandes O, Alegrete J, Parraca JA. Standardized Outcomes Measures in Physical Therapy Practice for Treatment and Rehabilitation of Cerebral PALSY: A Systematic Review. J Pers Med. 2021 Jun 26;11(7):604. doi: 10.3390/jpm11070604.</citation>
      <PMID>34206816</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>Cerebral palsy</keyword>
    <keyword>hippotherapy</keyword>
    <keyword>walking</keyword>
    <keyword>balance</keyword>
    <keyword>life quality</keyword>
    <keyword>diplegia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paralysis</mesh_term>
      <mesh_term>Cerebral Palsy</mesh_term>
      <mesh_term>Mobility Limitation</mesh_term>
    </condition_browse>
    <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/NCT06003868
  org study id: Uskudar72
  nct id: NCT06003868
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to examine the effect of hippotherapy simulator on trunk control,
        balance and gait in children with spastic diplegia cerebral palsy and its relationship with
        quality of life.
  Patients diagnosed with spastic diplegia cerebral palsy in the study; It will be classified
        according to Gross Motor Function Classification System (KMFSS). The Trunk Control
        Measurement Scale will be used to assess trunk control. Pediatric Berg Balance Scale will be
        used to assess balance. The 1 Minute Walk Test and the Timed Get Up and Go test will be used
        to assess walking. The WEEFIM scale will be used to assess quality of life. The study sample
        will be divided into two groups. The first group will receive 45 minutes of conventional
        physical therapy. In addition to 45 minutes of physical therapy, the other group will receive
        15 minutes of hippotherapy simulator. The results will be compared at the beginning and end
        of the study.
  
        Then, individuals will be divided into two groups with a simple randomized method.
        Traditional physical therapy will be applied to the control group for 45 minutes, 2 days a
        week, for 8 weeks. In addition to traditional physical therapy, 15 minutes of therapy
        training with a hippotherapy device will be applied to the experimental group. Evaluation
        tests will be repeated at the beginning and end of the study. Pre- and post-intervention data
        were statistically analyzed and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Exercises with Hippotherapy Simulator: This exercise will be applied to the group for 8 weeks, 2 days a week, as a single session (15 minutes) a day. The patients will be placed on the simulator and the starting position will be taught. They will be warned to maintain the starting position throughout the movements of the simulator. The hippotherapy simulator will be operated almost in the gait pattern of the horse and in the 1st stage of the 3-stage speed level. If the patients have unusual complaints such as dizziness, blackout, chest pain and risk of falling during the application. they will be advised to request to stop the application
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Pediatric Berg Balance Scale
  time frame: 10 weeks
  description: Berg Balance Scale was designed for children to evaluate functions in activities of daily living.
  version. The scale consists of 14 assessments and each section is scored between 0-4; The highest possible score is 56.
  measure: Trunk Control Measurement Scale
  time frame: 10 weeks
  description: For this reason, the scale consists of two parts: Static Sitting Balance (SSB) and Dynamic Sitting Balance (DSB). The DSB section also consists of two sub-parameters as selective motion control and dynamic reach. While the static sitting balance subscale evaluates static trunk control during lower and upper extremity movements, the selective motion control subscale evaluates selective trunk movements in three planes (flexion/extension, rotation, and lateral flexion). The dynamic reach subscale evaluates performance during reaching tasks that require active trunk movement. The scale consists of 15 items in total (subscales 5, 7 and 3 items, respectively). Items are scored on a 2, 3, and 4-point ordinal scale and are administered bilaterally when clinically significant. While the total score of the scale varies between 0-58 points, higher scores indicate a better performance.
  measure: 1 Minute Walk Test
  time frame: 10 weeks
  description: First, the child puts on his own clothes and shoes. He is allowed to use his splints and suitable walking aid. At least 5 minutes before starting the test. He is allowed to rest and then brought to the starting point of the path he will walk. When the command is given, it is said to start walking as fast as possible for 1 minute. It is also reported that he is not allowed to run. The distance is then calculated.
  measure: Timed get up and go test
  time frame: 10 weeks
  description: It is a test used to measure mobility and assesses walking speed, postural control, functional mobility and balance. The Timed Get Up and Go Test measures the time it takes for a person to get up from an arm-supported chair, turn by walking 3 m, and walk back to the chair, then sit down. The time it takes to get up from the chair and sit back on the chair is recorded.
  measure: Functional independence measurement for children (WEEFIM)
  time frame: 10 weeks
  description: It was developed to assess the level of functional independence of children with a physical disability and consists of three main categories and a total of 18 questions. A total of 18 questions under the heading of self-care, mobility and cognitive function categories are scored between 1 and 7. According to this; While performing the function to be evaluated, the child with a physical disability gets 1 point if he/she does it completely with assistance, and 7 points if he/she does it completely independently. The lowest score that the child can get from the scale is 18, and the highest score is 126.
  arm group label: control group
  arm group type: Active Comparator
  description: Physiotherapy will be applied for 8 weeks, 2 days a week, as one session per day (45 minutes).
  arm group label: hippotherapy group
  arm group type: Experimental
  description: Physiotherapy will be applied for 8 weeks, 2 days a week, one session a day (45 minutes). In addition, the patients will be placed on the simulator and the starting position will be taught. your simulator They will be warned before and during the application to maintain the starting position throughout their movements.
  pattern and will be run in the 1st stage of the 3-stage speed level.
  intervention type: Other
  intervention name: traditional physiotherapy
  description: Stretching for patients with spasticity exercises walking exercises for balance and gait disorders muscle strengthening exercises relaxation exercises
  arm group label: control group
  arm group label: hippotherapy group
  intervention type: Other
  intervention name: hippotherapy-assisted physiotherapy
  description: The patients will be placed on the simulator and the starting position will be taught. your simulator before the application and in order to maintain the starting position throughout their movements.
  they will be warned during the applications.. Hippotherapy simulator is almost like walking.
  pattern and will be run in the 1st stage of the 3-stage speed level.
  arm group label: hippotherapy group
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 16 Years
  healthy volunteers: No
  last name: Pelin GÜNEŞ
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  country: Turkey
  citation: Matusiak-Wieczorek E, Dziankowska-Zaborszczyk E, Synder M, Borowski A. The Influence of Hippotherapy on the Body Posture in a Sitting Position among Children with Cerebral Palsy. Int J Environ Res Public Health. 2020 Sep 19;17(18):6846. doi: 10.3390/ijerph17186846.
  PMID: 32961681
  citation: Hausler M, Heussen N. Protocol for a systematic review and meta-analysis on the effect of hippotherapy and related equine-assisted therapies on motor capabilities in children with cerebral palsy. Syst Rev. 2020 Mar 5;9(1):48. doi: 10.1186/s13643-020-01297-7.
  PMID: 32138777
  citation: Hyun C, Kim K, Lee S, Ko N, Lee IS, Koh SE. The Short-term Effects of Hippotherapy and Therapeutic Horseback Riding on Spasticity in Children With Cerebral Palsy: A Meta-analysis. Pediatr Phys Ther. 2022 Apr 1;34(2):172-178. doi: 10.1097/PEP.0000000000000880.
  PMID: 35184078
  citation: Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
  PMID: 32086598
  citation: Apolo-Arenas MD, Jeronimo AFA, Cana-Pino A, Fernandes O, Alegrete J, Parraca JA. Standardized Outcomes Measures in Physical Therapy Practice for Treatment and Rehabilitation of Cerebral PALSY: A Systematic Review. J Pers Med. 2021 Jun 26;11(7):604. doi: 10.3390/jpm11070604.
  PMID: 34206816
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor
  mesh term: Paralysis
  mesh term: Cerebral Palsy
  mesh term: Mobility Limitation
  sharing ipd: No