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/NCT05966428</url>
    </required_header>
    <id_info>
      <org_study_id>KAEU-T.ATAHAN-001</org_study_id>
      <nct_id>NCT05966428</nct_id>
    </id_info>
    <brief_title>Sensory Integration Therapy and Cerebral Palsy</brief_title>
    <official_title>The Affect of Sensory Integration Therapy and Conventional Exercise Therapy on Spasticity, Balance and Motor Function With Spastic Diplegic Cerebral Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kirsehir Ahi Evran Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kirsehir Ahi Evran Universitesi</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>
        This intervention study was planned to investigate the effects of Sensory Integration Therapy&#xD;
        that added to the conventional therapy program on spasticity, balance, motor function and&#xD;
        functional independency levels of children with spastic diplegic cerebral palsy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cerebral Palsy is a disease that can cause motor skill and posture disorders due to a&#xD;
        non-progressive lesion in the brain that has not yet completed its development. Cerebral&#xD;
        palsy is among the most common causes of disability in childhood. There are many conditions&#xD;
        that can cause Cerebral Palsy. Risk groups that cause brain damage can be considered as&#xD;
        prenatal, perinatal and postnatal risk factors.The lesion that occurs in the central nervous&#xD;
        system in patients with Cerebral Palsy causes some problems in the musculoskeletal system,&#xD;
        nervous system and sensory systems. In addition to these problems, depending on the level of&#xD;
        the lesion, posture, movement disorders and balance problems occur in individuals with&#xD;
        Cerebral Palsy. Sensory integration therapy is a neurological process of perceiving,&#xD;
        interpreting and organizing our senses for an effective integration of the individual with&#xD;
        the environment. When the literature is examined, the number of studies investigating the&#xD;
        effect of sensory integration program in children with spastic diplegic type Cerebral Palsy&#xD;
        is insufficient. The aim of this study is to investigate the effect of sensory integration&#xD;
        therapy on spasticity, balance and motor function in children with spastic diplegic type&#xD;
        Cerebral Palsy and to provide the data obtained at the end of the study to the literature&#xD;
        both theoretically and practically.&#xD;
  &#xD;
        The hypothesis of the study is:&#xD;
  &#xD;
          -  Sensory integration program reduces spasticity in children with spastic diplegic type&#xD;
             Cerebral Palsy.&#xD;
  &#xD;
          -  Sensory integration program increases balance in children with spastic diplegic type&#xD;
             Cerebral Palsy.&#xD;
  &#xD;
          -  Sensory integration program increases motor function in children with spastic diplegic&#xD;
             type Cerebral Palsy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">June 1, 2018</completion_date>
    <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The study consisted of 2 groups as control and experiment.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Muscle Tone</measure>
      <time_frame>A day before the rehabilitation</time_frame>
      <description>Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Muscle Tone</measure>
      <time_frame>8 week</time_frame>
      <description>Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Balance</measure>
      <time_frame>A day before the rehabilitation</time_frame>
      <description>Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Balance</measure>
      <time_frame>8 week</time_frame>
      <description>Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gross Motor Function</measure>
      <time_frame>A day before the rehabilitation</time_frame>
      <description>Gross Motor Function Measure (The scores are in 4 categories as &quot;0&quot; not starting the activity, starting independently &quot;1&quot;, partially completing &quot;2&quot; and independently completing &quot;3&quot;.)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gross Motor Function</measure>
      <time_frame>8 week</time_frame>
      <description>Gross Motor Function Measure (The scores are in 4 categories as &quot;0&quot; not starting the activity, starting independently &quot;1&quot;, partially completing &quot;2&quot; and independently completing &quot;3&quot;.)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Independence</measure>
      <time_frame>A day before the rehabilitation</time_frame>
      <description>Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Independence</measure>
      <time_frame>8 week</time_frame>
      <description>Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gross Motor Function Classification</measure>
      <time_frame>A day before the rehabilitation</time_frame>
      <description>Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gross Motor Function Classification</measure>
      <time_frame>8 week</time_frame>
      <description>Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conventional Exercises</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Conventional Exercises + Sensory Integration Therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional Exercises</intervention_name>
      <description>This conventional exercises included stretching and strengthening, balance-coordination, mobility and range of motion exercises.&#xD;
  The control group received conventional therapy 3 days a week for 8 weeks. Each therapy session a day lasted 45 minutes in control group.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sensory Integration Therapy</intervention_name>
      <description>The Sensory Integration Therapy was applied to the intervention group in addition to the conventional exercise program. Sensory Integration Therapy included tactile, proprioceptive, and vestibular activities. The tactile sensory activities consisted of materials such as stepping stones, tactile box, brushing, fabric walking path. The vestibular sensory activities consisted of materials such as hammock swings, trampolines, rope nets, rock walls, river stones. Proprioceptive sensory activities consisted of materials such as weight bearing activities, heavy lifting, deep pressure, big ball activities, tug of war and ball pits.&#xD;
  The intervention group underwent each session 45 minute conventional therapy and 15 minutes SIT. The therapy program continued 3 days a week for 8 weeks in intervention group.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between the ages of 4-17&#xD;
  &#xD;
            -  Diagnosed with spastic diplegic type Cerebral Palsy&#xD;
  &#xD;
            -  Having Gross Motor Function Classification System levels I and II&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children who underwent phenol and botulinum toxin-a injections in the last 6 months&#xD;
               before the study&#xD;
  &#xD;
            -  Had a previous surgical operation, and had a cardiopulmonary disease that could&#xD;
               prevent exercise&#xD;
  &#xD;
            -  Children with communication, hearing and vision problems&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Atahan TURHAN, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kirsehir Ahi Evran University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Atahan TURHAN</name>
        <address>
          <city>Kirsehir</city>
          <state>Merkez</state>
          <zip>40100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Kantor J, Hlavackova L, Du J, Dvorakova P, Svobodova Z, Karasova K, Kantorova L. The Effects of Ayres Sensory Integration and Related Sensory Based Interventions in Children with Cerebral Palsy: A Scoping Review. Children (Basel). 2022 Apr 1;9(4):483. doi: 10.3390/children9040483.</citation>
      <PMID>35455527</PMID>
    </results_reference>
    <results_reference>
      <citation>Warutkar VB, Krishna Kovela R. Review of Sensory Integration Therapy for Children With Cerebral Palsy. Cureus. 2022 Oct 26;14(10):e30714. doi: 10.7759/cureus.30714. eCollection 2022 Oct.</citation>
      <PMID>36439588</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kirsehir Ahi Evran Universitesi</investigator_affiliation>
      <investigator_full_name>Atahan TURHAN</investigator_full_name>
      <investigator_title>Principal Investigator: Atahan Turhan, PhD</investigator_title>
    </responsible_party>
    <keyword>Sensory Integration</keyword>
    <keyword>Physical Therapy and Rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cerebral Palsy</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/NCT05966428
  org study id: KAEU-T.ATAHAN-001
  nct id: NCT05966428
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This intervention study was planned to investigate the effects of Sensory Integration Therapy
        that added to the conventional therapy program on spasticity, balance, motor function and
        functional independency levels of children with spastic diplegic cerebral palsy
  Cerebral Palsy is a disease that can cause motor skill and posture disorders due to a
        non-progressive lesion in the brain that has not yet completed its development. Cerebral
        palsy is among the most common causes of disability in childhood. There are many conditions
        that can cause Cerebral Palsy. Risk groups that cause brain damage can be considered as
        prenatal, perinatal and postnatal risk factors.The lesion that occurs in the central nervous
        system in patients with Cerebral Palsy causes some problems in the musculoskeletal system,
        nervous system and sensory systems. In addition to these problems, depending on the level of
        the lesion, posture, movement disorders and balance problems occur in individuals with
        Cerebral Palsy. Sensory integration therapy is a neurological process of perceiving,
        interpreting and organizing our senses for an effective integration of the individual with
        the environment. When the literature is examined, the number of studies investigating the
        effect of sensory integration program in children with spastic diplegic type Cerebral Palsy
        is insufficient. The aim of this study is to investigate the effect of sensory integration
        therapy on spasticity, balance and motor function in children with spastic diplegic type
        Cerebral Palsy and to provide the data obtained at the end of the study to the literature
        both theoretically and practically.
  
        The hypothesis of the study is:
  
          -  Sensory integration program reduces spasticity in children with spastic diplegic type
             Cerebral Palsy.
  
          -  Sensory integration program increases balance in children with spastic diplegic type
             Cerebral Palsy.
  
          -  Sensory integration program increases motor function in children with spastic diplegic
             type Cerebral Palsy.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The study consisted of 2 groups as control and experiment.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Muscle Tone
  time frame: A day before the rehabilitation
  description: Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
  measure: Muscle Tone
  time frame: 8 week
  description: Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
  measure: Functional Balance
  time frame: A day before the rehabilitation
  description: Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )
  measure: Functional Balance
  time frame: 8 week
  description: Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)
  measure: Gross Motor Function
  time frame: A day before the rehabilitation
  description: Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)
  measure: Gross Motor Function
  time frame: 8 week
  description: Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)
  measure: Functional Independence
  time frame: A day before the rehabilitation
  description: Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
  measure: Functional Independence
  time frame: 8 week
  description: Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
  measure: Gross Motor Function Classification
  time frame: A day before the rehabilitation
  description: Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
  measure: Gross Motor Function Classification
  time frame: 8 week
  description: Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
  arm group label: Control Group
  arm group type: Active Comparator
  description: Conventional Exercises
  arm group label: Intervention Group
  arm group type: Experimental
  description: Conventional Exercises + Sensory Integration Therapy
  intervention type: Other
  intervention name: Conventional Exercises
  description: This conventional exercises included stretching and strengthening, balance-coordination, mobility and range of motion exercises.
  The control group received conventional therapy 3 days a week for 8 weeks. Each therapy session a day lasted 45 minutes in control group.
  arm group label: Control Group
  arm group label: Intervention Group
  intervention type: Other
  intervention name: Sensory Integration Therapy
  description: The Sensory Integration Therapy was applied to the intervention group in addition to the conventional exercise program. Sensory Integration Therapy included tactile, proprioceptive, and vestibular activities. The tactile sensory activities consisted of materials such as stepping stones, tactile box, brushing, fabric walking path. The vestibular sensory activities consisted of materials such as hammock swings, trampolines, rope nets, rock walls, river stones. Proprioceptive sensory activities consisted of materials such as weight bearing activities, heavy lifting, deep pressure, big ball activities, tug of war and ball pits.
  The intervention group underwent each session 45 minute conventional therapy and 15 minutes SIT. The therapy program continued 3 days a week for 8 weeks in intervention group.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Atahan TURHAN, PhD
  role: Principal Investigator
  affiliation: Kirsehir Ahi Evran University
  facility: 
  country: Turkey
  citation: Kantor J, Hlavackova L, Du J, Dvorakova P, Svobodova Z, Karasova K, Kantorova L. The Effects of Ayres Sensory Integration and Related Sensory Based Interventions in Children with Cerebral Palsy: A Scoping Review. Children (Basel). 2022 Apr 1;9(4):483. doi: 10.3390/children9040483.
  PMID: 35455527
  citation: Warutkar VB, Krishna Kovela R. Review of Sensory Integration Therapy for Children With Cerebral Palsy. Cureus. 2022 Oct 26;14(10):e30714. doi: 10.7759/cureus.30714. eCollection 2022 Oct.
  PMID: 36439588
  responsible party type: Principal Investigator
  investigator affiliation: Kirsehir Ahi Evran Universitesi
  investigator full name: Atahan TURHAN
  investigator title: Principal Investigator: Atahan Turhan, PhD
  mesh term: Cerebral Palsy
  sharing ipd: No