<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/NCT04403113</url>
  </required_header>
  <id_info>
    <org_study_id>09.2018.278</org_study_id>
    <nct_id>NCT04403113</nct_id>
  </id_info>
  <brief_title>The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.</brief_title>
  <official_title>The Effects of Neurodevelopmental Therapy on Feeding and Swallowing Activities in Children With Cerebral Palsy.</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>Yes</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>
      Our study is planned to investigate the effects of neck and trunk stabilization exercises,&#xD;
      which are structured from Neurodevelopmental therapy method-Bobath concept (NDT-B)&#xD;
      principles, on feeding and swallowing activity in children with Cerebral Palsy (CP) who take&#xD;
      feeding and oral motor intervention strategies. The cases were divided into two groups, which&#xD;
      is the group receiving feeding and oral motor intervention strategies+structured neck and&#xD;
      trunk stabilization exercises (n=20) (Study Group) and those receiving feeding and oral motor&#xD;
      intervention strategies (n=20) (Control Group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Feeding and oral motor interventions address different aspects of feeding difficulties,&#xD;
      reflecting the range in specific problems associated with feeding and nutrition in CP.&#xD;
&#xD;
      The trunk plays an important role in the organization of postural control and balance&#xD;
      reactions because it holds the centre of all body mass and holds therefore, the centre of&#xD;
      gravity. The trunk also provides stable attachment points to those muscles that control the&#xD;
      head and neck regions. &quot;Neck and trunk stabilization exercises&quot; were the basis of static and&#xD;
      dynamic balance abilities, and that increased neck and trunk stability might have had a&#xD;
      positive effect thereon.&#xD;
&#xD;
      To achieve the alignment of the head with the trunk, the pelvis must be stabilized. This has&#xD;
      important consequences for the entire process of swallowing. If the head is not stable, then&#xD;
      the fine movements of the jaw and tongue needed for feeding will be impaired. With feeding&#xD;
      and oral motor interventions and structured neck and trunk stabilization exercises, these&#xD;
      parameters are positively affected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2018</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gross Motor Function Classification System (GMFCS)</measure>
    <time_frame>Immediately before the intervention, the evaluation was performed in the first session (only one time).</time_frame>
    <description>The gross motor functions of children with cerebral palsy were classified with GMFCS. GMFCS is a 5-level classification system. It uses gross motor skills. The aim is to present an idea of how self-sufficient a child can be at home, at school, and outdoor and indoor venues. GMFCS includes levels that reflect abilities ranging from unlimited walking (level I) to severe head and trunk control limitations. Requires extensive use of assisted technology and physical assistance, and wheelchair (level V). The higher level in GMFCS means a worse and severe outcome. The low levels mean good motor function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the Eating and Drinking Ability Classification System (EDACS)</measure>
    <time_frame>Immediately before the intervention, the evaluation was performed in the first session (only one time).</time_frame>
    <description>EDACS describes the eating and drinking skills of children with cerebral palsy from the age of 3. It is an ordered scale that defines the degree of assistance required during the meal and the individual's ability to eat and drink between five levels. Level I, safely and efficiently eating and drinking; at level V, it indicates unable to eat or drink safely, relies on tube feeding and is at high risk for aspiration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the Mini-Manual Ability Classification System (Mini-MACS)</measure>
    <time_frame>Immediately before the intervention, the evaluation was performed in the first session (only one time).</time_frame>
    <description>Mini-MACS is a functional classification that defines how children with cerebral palsy between the ages of 1 and 4 use their hands while holding objects in daily activities. Skill classes at five levels, based on the need for self-help and adaptation when children hold objects. Level I. Handles objects easily and successfully. Level V. Does not handle objects and has severely limited ability to perform even simple actions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trunk Impairment Scale (TIS)</measure>
    <time_frame>Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).</time_frame>
    <description>TIS is a validated scale for cerebral palsy that evaluates the trunk functionally in terms of strength in a sitting position. It also complies with the International Classification of Functionality, Disability and Health in terms of evaluating the static and dynamic balance and trunk coordination of the trunk and the relationship between body function and structures. TIS consists of three subscales: static, dynamic and coordination. For each item; sequential scales with 2, 3 or 4 values are used. The highest scores that can be obtained from the static, dynamic and coordination subscales are; it is 7, 10 and 6 points. Total points are obtained by adding all subscales. The total TIS score ranges from 0 to 23. A high score indicates good trunk control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schedule for Oral Motor Assessment (SOMA)</measure>
    <time_frame>Change from SOMA was assessed in 0 week (Baseline, in the first session, Before treatment), 6. week (6 weeks after treatment, in the 12th session, After treatment).</time_frame>
    <description>SOMA is a measure which identifies &quot;oral-motor dysfunction&quot; (OMD). SOMA involves videotaping children and later assessing their feeding skills. Test was implemented in the presence of the child's main caregiver. The entire assessment lasted 20-30 minutes. SOMA has 7 subcategories. Each subcategory has its own cut-off point. Among the &quot;yes&quot; or &quot;no&quot; options opposite the observed parameters, the appropriate one is marked. In some options, the &quot;yes&quot; option indicates an abnormal function, while in some options the &quot;no&quot; option indicates the presence of an abnormal function. BOTTLE, TRAINER CUP, CUP(Cutting Score): ≥ 5 indicates OMD. &lt; 5 indicates normal oral-motor function(OMF). PUREE: ≥ 3 indicates OMD. &lt; 3 indicates normal OMF. SEMI-SOLIDS, SOLIDS: ≥ 4 indicates OMD. &lt; 4 indicates normal OMF. CRACKER: ≥ 9 indicates OMD. &lt; 9 indicates normal OMF. BOTTLE, CUP, PUREE, SOLIDS; minimum(mi) score: 0, maximum(ma): 9. TRAINER CUP; mi: 0, ma: 14. SEMI-SOLIDS; mi: 0, ma: 8. CRACKER; mi: 0, ma: 22.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pediatric Quality of Life Inventory (PedsQL)</measure>
    <time_frame>Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).</time_frame>
    <description>The Quality of Life Scale for Children is a general quality of life scale which assesses the physical and psychosocial experiences independent of disease in children between the ages of 2 and 18 years. The scale is composed of 23 items. The items are scored between 0 and 100. The higher the score for the Quality of Life Scale for children, the better is the perception of health-related quality of life. In our study, the total score of the scale was used.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Fiberoptic Endoscopic Evaluation of Swallowing (FEES)</measure>
    <time_frame>It was applied after the evaluation in the first session.</time_frame>
    <description>Instrumental evaluation of swallowing is a technique that allows the evaluation of swallowing physiology and anatomy in patients. The most commonly used form in the clinic is Flexible Fiberoptic Endoscopic Methods. The structures and functions related to swallowing are evaluated using through a fiberoptic tube extending from the nose to the pharynx. FEES allows direct visualization of some aspects of the pharyngeal phase. It gives information about the physiological changes that occur before and after swallowing. Since velopharyngeal closure occurs during swallowing, observation cannot be made. The pharynx, tongue root vallecula, pyriform sinuses, and residues formed after swallowing in the airway can be traced. There is no uniform decision to decide if a child should switch from oral feeding to enteral tube feeding, but there is a general consensus.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Study Group (SG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding (Study Group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (CG).</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Structured neck and trunk stabilization exercises</intervention_name>
    <description>Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.</description>
    <arm_group_label>Study Group (SG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Feeding and oral motor intervention strategies</intervention_name>
    <description>Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.</description>
    <arm_group_label>Control Group (CG).</arm_group_label>
    <arm_group_label>Study Group (SG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caregiver training related to feeding</intervention_name>
    <description>In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
    <arm_group_label>Control Group (CG).</arm_group_label>
    <arm_group_label>Study Group (SG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cases with Cerebral Palsy who had difficulties in feeding/swallowing skills.&#xD;
&#xD;
          -  Cases who were cooperative without communication barriers and volunteering to&#xD;
             participate in the study were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In the Videoendoscopic Swallowing Study, he/she was not included in the study if&#xD;
             he/she had an aspiration or aspiration risk, had advanced vision and hearing loss,&#xD;
             used any pharmacological agent to inhibit spasticity, or had undergone orthopaedic&#xD;
             surgery or Botulinum Toxin-A injection in the past six months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>54 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nasim EJRAEI, Master D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gonul Acar, Assoc. Prof</last_name>
    <role>Study Director</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marmara University Pendik Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Pendik</state>
        <zip>0216 625 45 45/34899</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://www.nature.com/articles/ejcn2013224#citeas</url>
    <description>Feeding children with cerebral palsy and swallowing difficulties</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/15185730</url>
    <description>The importance of postural control for feeding.</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5430291/</url>
    <description>The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series</description>
  </link>
  <link>
    <url>https://link.springer.com/article/10.1007/BF00260975</url>
    <description>The objective rating of oral-motor functions during feeding</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <results_first_submitted>May 30, 2020</results_first_submitted>
  <results_first_submitted_qc>November 15, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 8, 2020</results_first_posted>
  <last_update_submitted>November 15, 2020</last_update_submitted>
  <last_update_submitted_qc>November 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neck-trunk stabilization exercise. Feeding. Swallowing</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT04403113/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT04403113/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT04403113/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Study Group (SG)</title>
          <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to</description>
        </group>
        <group group_id="P2">
          <title>Control Group (CG).</title>
          <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Group (SG)</title>
          <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to</description>
        </group>
        <group group_id="B2">
          <title>Control Group (CG).</title>
          <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age range</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>(18-48 months) &lt;</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ (48 months)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Syria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cerebral Palsy type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>diplegic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>hemiplegic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>quadriplegic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>hypotonic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>dyskinetic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Gross Motor Function Classification System (GMFCS)</title>
        <description>The gross motor functions of children with cerebral palsy were classified with GMFCS. GMFCS is a 5-level classification system. It uses gross motor skills. The aim is to present an idea of how self-sufficient a child can be at home, at school, and outdoor and indoor venues. GMFCS includes levels that reflect abilities ranging from unlimited walking (level I) to severe head and trunk control limitations. Requires extensive use of assisted technology and physical assistance, and wheelchair (level V). The higher level in GMFCS means a worse and severe outcome. The low levels mean good motor function.</description>
        <time_frame>Immediately before the intervention, the evaluation was performed in the first session (only one time).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group (SG)</title>
            <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (CG).</title>
            <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
          </group>
        </group_list>
        <measure>
          <title>Gross Motor Function Classification System (GMFCS)</title>
          <description>The gross motor functions of children with cerebral palsy were classified with GMFCS. GMFCS is a 5-level classification system. It uses gross motor skills. The aim is to present an idea of how self-sufficient a child can be at home, at school, and outdoor and indoor venues. GMFCS includes levels that reflect abilities ranging from unlimited walking (level I) to severe head and trunk control limitations. Requires extensive use of assisted technology and physical assistance, and wheelchair (level V). The higher level in GMFCS means a worse and severe outcome. The low levels mean good motor function.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>level 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>the Eating and Drinking Ability Classification System (EDACS)</title>
        <description>EDACS describes the eating and drinking skills of children with cerebral palsy from the age of 3. It is an ordered scale that defines the degree of assistance required during the meal and the individual's ability to eat and drink between five levels. Level I, safely and efficiently eating and drinking; at level V, it indicates unable to eat or drink safely, relies on tube feeding and is at high risk for aspiration.</description>
        <time_frame>Immediately before the intervention, the evaluation was performed in the first session (only one time).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group (SG)</title>
            <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding.&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (CG).</title>
            <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
          </group>
        </group_list>
        <measure>
          <title>the Eating and Drinking Ability Classification System (EDACS)</title>
          <description>EDACS describes the eating and drinking skills of children with cerebral palsy from the age of 3. It is an ordered scale that defines the degree of assistance required during the meal and the individual's ability to eat and drink between five levels. Level I, safely and efficiently eating and drinking; at level V, it indicates unable to eat or drink safely, relies on tube feeding and is at high risk for aspiration.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>level 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>the Mini-Manual Ability Classification System (Mini-MACS)</title>
        <description>Mini-MACS is a functional classification that defines how children with cerebral palsy between the ages of 1 and 4 use their hands while holding objects in daily activities. Skill classes at five levels, based on the need for self-help and adaptation when children hold objects. Level I. Handles objects easily and successfully. Level V. Does not handle objects and has severely limited ability to perform even simple actions.</description>
        <time_frame>Immediately before the intervention, the evaluation was performed in the first session (only one time).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group (SG)</title>
            <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (CG).</title>
            <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
          </group>
        </group_list>
        <measure>
          <title>the Mini-Manual Ability Classification System (Mini-MACS)</title>
          <description>Mini-MACS is a functional classification that defines how children with cerebral palsy between the ages of 1 and 4 use their hands while holding objects in daily activities. Skill classes at five levels, based on the need for self-help and adaptation when children hold objects. Level I. Handles objects easily and successfully. Level V. Does not handle objects and has severely limited ability to perform even simple actions.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>level 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>level 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trunk Impairment Scale (TIS)</title>
        <description>TIS is a validated scale for cerebral palsy that evaluates the trunk functionally in terms of strength in a sitting position. It also complies with the International Classification of Functionality, Disability and Health in terms of evaluating the static and dynamic balance and trunk coordination of the trunk and the relationship between body function and structures. TIS consists of three subscales: static, dynamic and coordination. For each item; sequential scales with 2, 3 or 4 values are used. The highest scores that can be obtained from the static, dynamic and coordination subscales are; it is 7, 10 and 6 points. Total points are obtained by adding all subscales. The total TIS score ranges from 0 to 23. A high score indicates good trunk control.</description>
        <time_frame>Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group (SG)</title>
            <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (CG).</title>
            <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
          </group>
        </group_list>
        <measure>
          <title>Trunk Impairment Scale (TIS)</title>
          <description>TIS is a validated scale for cerebral palsy that evaluates the trunk functionally in terms of strength in a sitting position. It also complies with the International Classification of Functionality, Disability and Health in terms of evaluating the static and dynamic balance and trunk coordination of the trunk and the relationship between body function and structures. TIS consists of three subscales: static, dynamic and coordination. For each item; sequential scales with 2, 3 or 4 values are used. The highest scores that can be obtained from the static, dynamic and coordination subscales are; it is 7, 10 and 6 points. Total points are obtained by adding all subscales. The total TIS score ranges from 0 to 23. A high score indicates good trunk control.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.65" spread="6.11"/>
                    <measurement group_id="O2" value="2.90" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Schedule for Oral Motor Assessment (SOMA)</title>
        <description>SOMA is a measure which identifies &quot;oral-motor dysfunction&quot; (OMD). SOMA involves videotaping children and later assessing their feeding skills. Test was implemented in the presence of the child's main caregiver. The entire assessment lasted 20-30 minutes. SOMA has 7 subcategories. Each subcategory has its own cut-off point. Among the &quot;yes&quot; or &quot;no&quot; options opposite the observed parameters, the appropriate one is marked. In some options, the &quot;yes&quot; option indicates an abnormal function, while in some options the &quot;no&quot; option indicates the presence of an abnormal function. BOTTLE, TRAINER CUP, CUP(Cutting Score): ≥ 5 indicates OMD. &lt; 5 indicates normal oral-motor function(OMF). PUREE: ≥ 3 indicates OMD. &lt; 3 indicates normal OMF. SEMI-SOLIDS, SOLIDS: ≥ 4 indicates OMD. &lt; 4 indicates normal OMF. CRACKER: ≥ 9 indicates OMD. &lt; 9 indicates normal OMF. BOTTLE, CUP, PUREE, SOLIDS; minimum(mi) score: 0, maximum(ma): 9. TRAINER CUP; mi: 0, ma: 14. SEMI-SOLIDS; mi: 0, ma: 8. CRACKER; mi: 0, ma: 22.</description>
        <time_frame>Change from SOMA was assessed in 0 week (Baseline, in the first session, Before treatment), 6. week (6 weeks after treatment, in the 12th session, After treatment).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group (CG).</title>
            <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
          </group>
          <group group_id="O2">
            <title>Study Group (SG)</title>
            <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding.</description>
          </group>
        </group_list>
        <measure>
          <title>Schedule for Oral Motor Assessment (SOMA)</title>
          <description>SOMA is a measure which identifies &quot;oral-motor dysfunction&quot; (OMD). SOMA involves videotaping children and later assessing their feeding skills. Test was implemented in the presence of the child's main caregiver. The entire assessment lasted 20-30 minutes. SOMA has 7 subcategories. Each subcategory has its own cut-off point. Among the &quot;yes&quot; or &quot;no&quot; options opposite the observed parameters, the appropriate one is marked. In some options, the &quot;yes&quot; option indicates an abnormal function, while in some options the &quot;no&quot; option indicates the presence of an abnormal function. BOTTLE, TRAINER CUP, CUP(Cutting Score): ≥ 5 indicates OMD. &lt; 5 indicates normal oral-motor function(OMF). PUREE: ≥ 3 indicates OMD. &lt; 3 indicates normal OMF. SEMI-SOLIDS, SOLIDS: ≥ 4 indicates OMD. &lt; 4 indicates normal OMF. CRACKER: ≥ 9 indicates OMD. &lt; 9 indicates normal OMF. BOTTLE, CUP, PUREE, SOLIDS; minimum(mi) score: 0, maximum(ma): 9. TRAINER CUP; mi: 0, ma: 14. SEMI-SOLIDS; mi: 0, ma: 8. CRACKER; mi: 0, ma: 22.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Trainer cup (Before treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10" spread="1.44"/>
                    <measurement group_id="O2" value="3.70" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trainer cup (After treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.75" spread="1.01"/>
                    <measurement group_id="O2" value="3.10" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Puree (Before treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.05" spread="0.99"/>
                    <measurement group_id="O2" value="2.10" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Puree (After treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" spread="1.20"/>
                    <measurement group_id="O2" value="1.55" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bottle (Before treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.55" spread="1.14"/>
                    <measurement group_id="O2" value="2.75" spread="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bottle (After treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.35" spread="1.63"/>
                    <measurement group_id="O2" value="2.70" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cup (Before treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.60" spread="1.53"/>
                    <measurement group_id="O2" value="2.50" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cup (After treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10" spread="1.41"/>
                    <measurement group_id="O2" value="1.95" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Semi solids (Before treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="1.30"/>
                    <measurement group_id="O2" value="2.05" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Semi solids (After treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.95" spread="1.39"/>
                    <measurement group_id="O2" value="1.90" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Solids (Before treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.70" spread="1.12"/>
                    <measurement group_id="O2" value="2.35" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Solids (After treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.35" spread="1.38"/>
                    <measurement group_id="O2" value="2.35" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cracker (Before treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="1.31"/>
                    <measurement group_id="O2" value="2.25" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cracker (After treatment)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" spread="1.38"/>
                    <measurement group_id="O2" value="2.10" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pediatric Quality of Life Inventory (PedsQL)</title>
        <description>The Quality of Life Scale for Children is a general quality of life scale which assesses the physical and psychosocial experiences independent of disease in children between the ages of 2 and 18 years. The scale is composed of 23 items. The items are scored between 0 and 100. The higher the score for the Quality of Life Scale for children, the better is the perception of health-related quality of life. In our study, the total score of the scale was used.</description>
        <time_frame>Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group (SG)</title>
            <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (CG).</title>
            <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Quality of Life Inventory (PedsQL)</title>
          <description>The Quality of Life Scale for Children is a general quality of life scale which assesses the physical and psychosocial experiences independent of disease in children between the ages of 2 and 18 years. The scale is composed of 23 items. The items are scored between 0 and 100. The higher the score for the Quality of Life Scale for children, the better is the perception of health-related quality of life. In our study, the total score of the scale was used.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.42" spread="18.33"/>
                    <measurement group_id="O2" value="53.48" spread="20.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Fiberoptic Endoscopic Evaluation of Swallowing (FEES)</title>
        <description>Instrumental evaluation of swallowing is a technique that allows the evaluation of swallowing physiology and anatomy in patients. The most commonly used form in the clinic is Flexible Fiberoptic Endoscopic Methods. The structures and functions related to swallowing are evaluated using through a fiberoptic tube extending from the nose to the pharynx. FEES allows direct visualization of some aspects of the pharyngeal phase. It gives information about the physiological changes that occur before and after swallowing. Since velopharyngeal closure occurs during swallowing, observation cannot be made. The pharynx, tongue root vallecula, pyriform sinuses, and residues formed after swallowing in the airway can be traced. There is no uniform decision to decide if a child should switch from oral feeding to enteral tube feeding, but there is a general consensus.</description>
        <time_frame>It was applied after the evaluation in the first session.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Study Group (SG)</title>
            <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding (Study Group)&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
          </group>
          <group group_id="O2">
            <title>Control Group (CG).</title>
            <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
          </group>
        </group_list>
        <measure>
          <title>Fiberoptic Endoscopic Evaluation of Swallowing (FEES)</title>
          <description>Instrumental evaluation of swallowing is a technique that allows the evaluation of swallowing physiology and anatomy in patients. The most commonly used form in the clinic is Flexible Fiberoptic Endoscopic Methods. The structures and functions related to swallowing are evaluated using through a fiberoptic tube extending from the nose to the pharynx. FEES allows direct visualization of some aspects of the pharyngeal phase. It gives information about the physiological changes that occur before and after swallowing. Since velopharyngeal closure occurs during swallowing, observation cannot be made. The pharynx, tongue root vallecula, pyriform sinuses, and residues formed after swallowing in the airway can be traced. There is no uniform decision to decide if a child should switch from oral feeding to enteral tube feeding, but there is a general consensus.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal swallowing and oral diet</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dysphagia and non-oral diet</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks for each participant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study Group (SG)</title>
          <description>feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding&#xD;
Structured neck and trunk stabilization exercises: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding.</description>
        </group>
        <group group_id="E2">
          <title>Control Group (CG).</title>
          <description>feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)&#xD;
Feeding and oral motor intervention strategies: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.&#xD;
Caregiver training related to feeding: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>In the study, it can be stated as the limitation of the study that all children with feeing problems are screened for only 40 cases and heterogeneous types are included in the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Assoc. Prof Gonul Acar</name_or_title>
      <organization>Marmara University</organization>
      <phone>5323778878 ext +90</phone>
      <email>gonulacar34@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04403113
org study id: 09.2018.278
nct id: NCT04403113
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Our study is planned to investigate the effects of neck and trunk stabilization exercises,
      which are structured from Neurodevelopmental therapy method-Bobath concept (NDT-B)
      principles, on feeding and swallowing activity in children with Cerebral Palsy (CP) who take
      feeding and oral motor intervention strategies. The cases were divided into two groups, which
      is the group receiving feeding and oral motor intervention strategies+structured neck and
      trunk stabilization exercises (n=20) (Study Group) and those receiving feeding and oral motor
      intervention strategies (n=20) (Control Group).
Feeding and oral motor interventions address different aspects of feeding difficulties,
      reflecting the range in specific problems associated with feeding and nutrition in CP.

      The trunk plays an important role in the organization of postural control and balance
      reactions because it holds the centre of all body mass and holds therefore, the centre of
      gravity. The trunk also provides stable attachment points to those muscles that control the
      head and neck regions. "Neck and trunk stabilization exercises" were the basis of static and
      dynamic balance abilities, and that increased neck and trunk stability might have had a
      positive effect thereon.

      To achieve the alignment of the head with the trunk, the pelvis must be stabilized. This has
      important consequences for the entire process of swallowing. If the head is not stable, then
      the fine movements of the jaw and tongue needed for feeding will be impaired. With feeding
      and oral motor interventions and structured neck and trunk stabilization exercises, these
      parameters are positively affected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Gross Motor Function Classification System (GMFCS)
time frame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
description: The gross motor functions of children with cerebral palsy were classified with GMFCS. GMFCS is a 5-level classification system. It uses gross motor skills. The aim is to present an idea of how self-sufficient a child can be at home, at school, and outdoor and indoor venues. GMFCS includes levels that reflect abilities ranging from unlimited walking (level I) to severe head and trunk control limitations. Requires extensive use of assisted technology and physical assistance, and wheelchair (level V). The higher level in GMFCS means a worse and severe outcome. The low levels mean good motor function.
measure: the Eating and Drinking Ability Classification System (EDACS)
time frame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
description: EDACS describes the eating and drinking skills of children with cerebral palsy from the age of 3. It is an ordered scale that defines the degree of assistance required during the meal and the individual's ability to eat and drink between five levels. Level I, safely and efficiently eating and drinking; at level V, it indicates unable to eat or drink safely, relies on tube feeding and is at high risk for aspiration.
measure: the Mini-Manual Ability Classification System (Mini-MACS)
time frame: Immediately before the intervention, the evaluation was performed in the first session (only one time).
description: Mini-MACS is a functional classification that defines how children with cerebral palsy between the ages of 1 and 4 use their hands while holding objects in daily activities. Skill classes at five levels, based on the need for self-help and adaptation when children hold objects. Level I. Handles objects easily and successfully. Level V. Does not handle objects and has severely limited ability to perform even simple actions.
measure: Trunk Impairment Scale (TIS)
time frame: Change from TIS was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
description: TIS is a validated scale for cerebral palsy that evaluates the trunk functionally in terms of strength in a sitting position. It also complies with the International Classification of Functionality, Disability and Health in terms of evaluating the static and dynamic balance and trunk coordination of the trunk and the relationship between body function and structures. TIS consists of three subscales: static, dynamic and coordination. For each item; sequential scales with 2, 3 or 4 values are used. The highest scores that can be obtained from the static, dynamic and coordination subscales are; it is 7, 10 and 6 points. Total points are obtained by adding all subscales. The total TIS score ranges from 0 to 23. A high score indicates good trunk control.
measure: Schedule for Oral Motor Assessment (SOMA)
time frame: Change from SOMA was assessed in 0 week (Baseline, in the first session, Before treatment), 6. week (6 weeks after treatment, in the 12th session, After treatment).
description: SOMA is a measure which identifies "oral-motor dysfunction" (OMD). SOMA involves videotaping children and later assessing their feeding skills. Test was implemented in the presence of the child's main caregiver. The entire assessment lasted 20-30 minutes. SOMA has 7 subcategories. Each subcategory has its own cut-off point. Among the "yes" or "no" options opposite the observed parameters, the appropriate one is marked. In some options, the "yes" option indicates an abnormal function, while in some options the "no" option indicates the presence of an abnormal function. BOTTLE, TRAINER CUP, CUP(Cutting Score): ≥ 5 indicates OMD. < 5 indicates normal oral-motor function(OMF). PUREE: ≥ 3 indicates OMD. < 3 indicates normal OMF. SEMI-SOLIDS, SOLIDS: ≥ 4 indicates OMD. < 4 indicates normal OMF. CRACKER: ≥ 9 indicates OMD. < 9 indicates normal OMF. BOTTLE, CUP, PUREE, SOLIDS; minimum(mi) score: 0, maximum(ma): 9. TRAINER CUP; mi: 0, ma: 14. SEMI-SOLIDS; mi: 0, ma: 8. CRACKER; mi: 0, ma: 22.
measure: Pediatric Quality of Life Inventory (PedsQL)
time frame: Change from PedsQL was assessed in 0 week (Baseline, in the first session), 6. week (6 weeks after treatment, in the 12th session).
description: The Quality of Life Scale for Children is a general quality of life scale which assesses the physical and psychosocial experiences independent of disease in children between the ages of 2 and 18 years. The scale is composed of 23 items. The items are scored between 0 and 100. The higher the score for the Quality of Life Scale for children, the better is the perception of health-related quality of life. In our study, the total score of the scale was used.
measure: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
time frame: It was applied after the evaluation in the first session.
description: Instrumental evaluation of swallowing is a technique that allows the evaluation of swallowing physiology and anatomy in patients. The most commonly used form in the clinic is Flexible Fiberoptic Endoscopic Methods. The structures and functions related to swallowing are evaluated using through a fiberoptic tube extending from the nose to the pharynx. FEES allows direct visualization of some aspects of the pharyngeal phase. It gives information about the physiological changes that occur before and after swallowing. Since velopharyngeal closure occurs during swallowing, observation cannot be made. The pharynx, tongue root vallecula, pyriform sinuses, and residues formed after swallowing in the airway can be traced. There is no uniform decision to decide if a child should switch from oral feeding to enteral tube feeding, but there is a general consensus.
arm group label: Study Group (SG)
arm group type: Experimental
description: feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises+caregiver training related to feeding (Study Group)
arm group label: Control Group (CG).
arm group type: Placebo Comparator
description: feeding and oral motor intervention strategies+caregiver training related to feeding (Control Group)
intervention type: Other
intervention name: Structured neck and trunk stabilization exercises
description: Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
arm group label: Study Group (SG)
intervention type: Other
intervention name: Feeding and oral motor intervention strategies
description: Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
arm group label: Control Group (CG).
arm group label: Study Group (SG)
intervention type: Other
intervention name: Caregiver training related to feeding
description: In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
arm group label: Control Group (CG).
arm group label: Study Group (SG)
criteria: 
gender: All
minimum age: 18 Months
maximum age: 54 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Nasim EJRAEI, Master D
role: Principal Investigator
affiliation: Marmara University
last name: Gonul Acar, Assoc. Prof
role: Study Director
affiliation: Marmara University
facility: 
country: Turkey
url: https://www.nature.com/articles/ejcn2013224#citeas
description: Feeding children with cerebral palsy and swallowing difficulties
url: https://www.ncbi.nlm.nih.gov/pubmed/15185730
description: The importance of postural control for feeding.
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5430291/
description: The effects of neck and trunk stabilization exercises on cerebral palsy children's static and dynamic trunk balance: case series
url: https://link.springer.com/article/10.1007/BF00260975
description: The objective rating of oral-motor functions during feeding
responsible party type: Sponsor
mesh term: Cerebral Palsy
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: In the study, it can be stated as the limitation of the study that all children with feeing problems are screened for only 40 cases and heterogeneous types are included in the study.
point of contact: 