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/NCT06041191</url>
    </required_header>
    <id_info>
      <org_study_id>E-77082166-604.01.02-687785</org_study_id>
      <nct_id>NCT06041191</nct_id>
    </id_info>
    <brief_title>Sensory Processing Skills in Toddler With Joint Hypermobility</brief_title>
    <official_title>An Investigation of Sensory Processing Skills in Toddler With Joint Hypermobility</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gazi University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        shows that children and adults with joint hypermobility may be identified with common&#xD;
        clinical problems that are unrelated, such as chronic fatigue, anxiety, and a range of&#xD;
        gastrointestinal functional disorders [4-6]. Considering the relationship of joint&#xD;
        hypermobility with joint muscle tone and posture, sensory processing skills may also be&#xD;
        affected in individuals with hypermobility. No study in the literature examines the&#xD;
        relationship between joint hypermobility and sensory processing. This study was planned to&#xD;
        detect joint hypermobility as early as 12-14 months and to examine its relationship with&#xD;
        sensory processing skills.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Actual">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">July 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Beighton Score</measure>
      <time_frame>20minutes</time_frame>
      <description>. The test consists of 5 items: (1) positive if the passive dorsiflexion of the fifth metacarpophalangeal joint score is greater than 90 degrees (bilateral test); (2) positive if passive hyperextension of the elbow joint is &gt;10 (bilateral test); (3) positive if passive hyperextension of the knee joint is &gt;10 (bilateral test); (4) passive apposition of the thumb to the flexor side of the forearm is positive for joint hypermobility (bilateral test) if the shoulder is at 90 flexion, the elbow is extended, and the whole thumb is touching the flexor side of the forearm; and (5) the score is positive when dorsiflexion of the ankle is &gt;30 (bilateral test). The assessment was performed on both the right and left sides, and the item was given 1 point if hypermobility was detected in the joints, and 0 points if not, according to the instructions of each item. Cut-off score of &gt;4 was used to define hypermobility</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Test of Sensory Functions in Infants</measure>
      <time_frame>20 minutes</time_frame>
      <description>The TSFI is primarily used to assess sensory defense behaviors in infants aged 4-18 months. Test; It consists of 5 subsections and 24 items. TSFI requires the infant to be stimulated and interact with a variety of materials. The total score varies between 0-49 and the test has norm values for different age groups. Although it is used from the fourth month, the most reliable and valid results are obtained between 7-18 months.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">58</enrollment>
    <condition>Child Development</condition>
    <condition>Sensory Disorder</condition>
    <condition>Hypermobility, Joint</condition>
    <arm_group>
      <arm_group_label>Children with GJH</arm_group_label>
      <description>Children who scored above 4 points in the hypermobility assessment made with the Beighton score were included in this group. sensory processing skills assessed with the Test of Sensory Functions in Infants</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Children without GJH</arm_group_label>
      <description>Children who scored below 4 points in the hypermobility assessment made with the Beighton score were included in this group. sensory processing skills assessed with the Test of Sensory Functions in Infants</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Assessment</intervention_name>
      <description>The children included in the study were evaluated in terms of hypermobility and then divided into two groups. Children in both groups were evaluated in terms of sensory processing skills.</description>
      <arm_group_label>Children with GJH</arm_group_label>
      <arm_group_label>Children without GJH</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy children born at term between 12-14 months&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          12-14 month old healthy children&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  they had major congenital malformations, had genetic or chromosomal abnormalities, had&#xD;
               known metabolic disorders, or had seizures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Months</minimum_age>
      <maximum_age>14 Months</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Erzurum Technical University</name>
        <address>
          <city>Erzurum</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gazi University</investigator_affiliation>
      <investigator_full_name>Ayse Simsek</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Instability</mesh_term>
      <mesh_term>Sensation Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06041191
  org study id: E-77082166-604.01.02-687785
  nct id: NCT06041191
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  shows that children and adults with joint hypermobility may be identified with common
        clinical problems that are unrelated, such as chronic fatigue, anxiety, and a range of
        gastrointestinal functional disorders [4-6]. Considering the relationship of joint
        hypermobility with joint muscle tone and posture, sensory processing skills may also be
        affected in individuals with hypermobility. No study in the literature examines the
        relationship between joint hypermobility and sensory processing. This study was planned to
        detect joint hypermobility as early as 12-14 months and to examine its relationship with
        sensory processing skills.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Beighton Score
  time frame: 20minutes
  description: . The test consists of 5 items: (1) positive if the passive dorsiflexion of the fifth metacarpophalangeal joint score is greater than 90 degrees (bilateral test); (2) positive if passive hyperextension of the elbow joint is >10 (bilateral test); (3) positive if passive hyperextension of the knee joint is >10 (bilateral test); (4) passive apposition of the thumb to the flexor side of the forearm is positive for joint hypermobility (bilateral test) if the shoulder is at 90 flexion, the elbow is extended, and the whole thumb is touching the flexor side of the forearm; and (5) the score is positive when dorsiflexion of the ankle is >30 (bilateral test). The assessment was performed on both the right and left sides, and the item was given 1 point if hypermobility was detected in the joints, and 0 points if not, according to the instructions of each item. Cut-off score of >4 was used to define hypermobility
  measure: Test of Sensory Functions in Infants
  time frame: 20 minutes
  description: The TSFI is primarily used to assess sensory defense behaviors in infants aged 4-18 months. Test; It consists of 5 subsections and 24 items. TSFI requires the infant to be stimulated and interact with a variety of materials. The total score varies between 0-49 and the test has norm values for different age groups. Although it is used from the fourth month, the most reliable and valid results are obtained between 7-18 months.
  arm group label: Children with GJH
  description: Children who scored above 4 points in the hypermobility assessment made with the Beighton score were included in this group. sensory processing skills assessed with the Test of Sensory Functions in Infants
  arm group label: Children without GJH
  description: Children who scored below 4 points in the hypermobility assessment made with the Beighton score were included in this group. sensory processing skills assessed with the Test of Sensory Functions in Infants
  intervention type: Diagnostic Test
  intervention name: Assessment
  description: The children included in the study were evaluated in terms of hypermobility and then divided into two groups. Children in both groups were evaluated in terms of sensory processing skills.
  arm group label: Children with GJH
  arm group label: Children without GJH
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Months
  maximum age: 14 Months
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Gazi University
  investigator full name: Ayse Simsek
  investigator title: assistant professor
  mesh term: Joint Instability
  mesh term: Sensation Disorders