<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/NCT04409730</url>
  </required_header>
  <id_info>
    <org_study_id>KA19/126</org_study_id>
    <nct_id>NCT04409730</nct_id>
  </id_info>
  <brief_title>Photographic Posture Analysis in Children With Cerebral Palsy</brief_title>
  <official_title>Reliability of Photographic Posture Analysis in Children With Cerebral Palsy and Its Relationship With Trunk Control and Motor Functions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baskent 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>
      Cerebral palsy (CP), which is the largest group of patients among pediatric neuromuscular&#xD;
      diseases, is a non-progressive permanent disorder that affects muscle control, movement,&#xD;
      posture and balance. The purpose of this study; to evaluate the reliability of photographic&#xD;
      posture analysis in the sitting position in children with CP and to examine the relationship&#xD;
      between the results of photographic posture analysis with the motor performances and trunk&#xD;
      control of children with CP.Children with CP were included in the study according to the&#xD;
      following criteria; aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a&#xD;
      level of &quot;I, II, III&quot; according to GMFCS. Postural evaluation was done using the photographic&#xD;
      method. Trunk control was evaluated with Trunk Control Measurement Scale,Motor performance of&#xD;
      children was evaluated with Gross Motor Function Measure-88. ICC values for photographic&#xD;
      posture analysis was found to be highly reliable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sitting position is of great importance in the development of upper extremity functions,&#xD;
      orthogonal functional skills, personal care, cognitive, perceptual and social skills in&#xD;
      children with cerebral palsy and these kids spend most of their time in a sitting&#xD;
      position.There are goniometer, inclinometer, flexicurve, spinal mouse, and modified head&#xD;
      posture spinal curvature ınstrument tools for posture analysis in the sitting&#xD;
      position.However, none of these measurement tools have been validated for validity and&#xD;
      reliability studies of head and trunk posture measurement in the sitting position in children&#xD;
      with CP. Methods such as magnetic resonance (MR) and x-ray used in posture evaluation provide&#xD;
      clear images of reference points and are the gold standard in the literature. However, they&#xD;
      are not preferred much because they are expensive and contain radiation.Photographic posture&#xD;
      analysis can be considered as a measurement method such as posture analysis methods using the&#xD;
      gravity line. It is a digital, more objective measurement method that measures linear&#xD;
      distances and angles using anatomical reference points using specially designed software.&#xD;
      Clinical use of photographic posture analysis is recommended in the literature, as it is an&#xD;
      accurate and objective method, preventing radiation exposure.The purpose of this study; to&#xD;
      evaluate the reliability of photographic posture analysis in the sitting position in children&#xD;
      with CP and to examine the relationship between the results of photographic posture analysis&#xD;
      with the motor performances and trunk control of children with CP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Photographic Posture Analysis</measure>
    <time_frame>45-60 minutes</time_frame>
    <description>Postural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trunk Control Measurement Scale (TCMS)</measure>
    <time_frame>30-40 minutes</time_frame>
    <description>Trunk control was evaluated with Trunk Control Measurement Scale is a scale that measures the static and dynamic sitting balance in children with CP. It consists of 15 items in total, 1-5 items measure Static Sitting Balance, 6-15 items measure dynamic sitting balance. Static sitting balance assesses the ability of children to maintain the trunk posture as they move their upper and lower limbs in the sitting posture. Dynamic sitting balance is divided into two sub-scales; selective motion control scale and dynamic reach scale. The maximum score that can be obtained from the test is 58. Higher scores perform better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross Motor Function Measure-88 (GMFM-88)</measure>
    <time_frame>30-45 minutes</time_frame>
    <description>GMFM-88 is a standardized observational test designed to measure the motor development levels of children with SP and their changes over time. It consists of five main headings and 88 items: lying and rolling; sitting; crawling and kneeling; standing; walking, running, and jumping. 17 of the 88 items are on the lying and rolling part, 20 on the sitting part, 14 on the crawling and kneeling part, 13 on the standing part, and 24 on the walking, running, and jumping part. Likert scale is used in scoring. The child gets 0 points if he / she cannot start the movement, 1 if he / she can start the movement independently, 2 if he / she can partially complete the movement, and 3 if he / she can complete the movement independently. A 5-year-old child with normal development is expected to score full of 88 items. The GMFM-88 was administered to the children by therapists trained in its use and tested to ensure an adequate level of competence by using a criterion test videotape</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Posture Disorders in Children</condition>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Children with Cerebral Palsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of &quot;I, II, III&quot; according to GMFCS</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Photographic Posture Analysis</intervention_name>
    <description>Postural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation. The camera was placed on a 115 cm high tripod, 1.5 m away from the subjects. Spirit levels have been adjusted so that the tripod is completely flat on the ground. The tripod was taped to the floor to maintain the same distance between the camera and the participants. Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers.</description>
    <arm_group_label>Children with Cerebral Palsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 5-12 years,&#xD;
&#xD;
          -  Diagnosed as spastic diplegia or hemiplegia,&#xD;
&#xD;
          -  Having a level of &quot;I, II, III&quot; according to GMFCS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who could not cooperate,&#xD;
&#xD;
          -  Have undergone spinal surgery, had botulinum toxin (BoNT) and surgical treatment in&#xD;
             the last 6 months&#xD;
&#xD;
          -  Had another neurodevelopmental or congenital disease other than CP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilay Çömük Balcı, Pt,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Baskent University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baskent University</name>
      <address>
        <city>Ankara</city>
        <state>Etimesgut</state>
        <zip>06790</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baskent University</investigator_affiliation>
    <investigator_full_name>Nilay Comuk Balci</investigator_full_name>
    <investigator_title>Pt, PhD, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>trunk</keyword>
  <keyword>posture analysis</keyword>
  <keyword>cerebral palsy</keyword>
  <keyword>performance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04409730
org study id: KA19/126
nct id: NCT04409730
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cerebral palsy (CP), which is the largest group of patients among pediatric neuromuscular
      diseases, is a non-progressive permanent disorder that affects muscle control, movement,
      posture and balance. The purpose of this study; to evaluate the reliability of photographic
      posture analysis in the sitting position in children with CP and to examine the relationship
      between the results of photographic posture analysis with the motor performances and trunk
      control of children with CP.Children with CP were included in the study according to the
      following criteria; aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a
      level of "I, II, III" according to GMFCS. Postural evaluation was done using the photographic
      method. Trunk control was evaluated with Trunk Control Measurement Scale,Motor performance of
      children was evaluated with Gross Motor Function Measure-88. ICC values for photographic
      posture analysis was found to be highly reliable.
Sitting position is of great importance in the development of upper extremity functions,
      orthogonal functional skills, personal care, cognitive, perceptual and social skills in
      children with cerebral palsy and these kids spend most of their time in a sitting
      position.There are goniometer, inclinometer, flexicurve, spinal mouse, and modified head
      posture spinal curvature ınstrument tools for posture analysis in the sitting
      position.However, none of these measurement tools have been validated for validity and
      reliability studies of head and trunk posture measurement in the sitting position in children
      with CP. Methods such as magnetic resonance (MR) and x-ray used in posture evaluation provide
      clear images of reference points and are the gold standard in the literature. However, they
      are not preferred much because they are expensive and contain radiation.Photographic posture
      analysis can be considered as a measurement method such as posture analysis methods using the
      gravity line. It is a digital, more objective measurement method that measures linear
      distances and angles using anatomical reference points using specially designed software.
      Clinical use of photographic posture analysis is recommended in the literature, as it is an
      accurate and objective method, preventing radiation exposure.The purpose of this study; to
      evaluate the reliability of photographic posture analysis in the sitting position in children
      with CP and to examine the relationship between the results of photographic posture analysis
      with the motor performances and trunk control of children with CP.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Photographic Posture Analysis
time frame: 45-60 minutes
description: Postural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers
measure: Trunk Control Measurement Scale (TCMS)
time frame: 30-40 minutes
description: Trunk control was evaluated with Trunk Control Measurement Scale is a scale that measures the static and dynamic sitting balance in children with CP. It consists of 15 items in total, 1-5 items measure Static Sitting Balance, 6-15 items measure dynamic sitting balance. Static sitting balance assesses the ability of children to maintain the trunk posture as they move their upper and lower limbs in the sitting posture. Dynamic sitting balance is divided into two sub-scales; selective motion control scale and dynamic reach scale. The maximum score that can be obtained from the test is 58. Higher scores perform better.
measure: Gross Motor Function Measure-88 (GMFM-88)
time frame: 30-45 minutes
description: GMFM-88 is a standardized observational test designed to measure the motor development levels of children with SP and their changes over time. It consists of five main headings and 88 items: lying and rolling; sitting; crawling and kneeling; standing; walking, running, and jumping. 17 of the 88 items are on the lying and rolling part, 20 on the sitting part, 14 on the crawling and kneeling part, 13 on the standing part, and 24 on the walking, running, and jumping part. Likert scale is used in scoring. The child gets 0 points if he / she cannot start the movement, 1 if he / she can start the movement independently, 2 if he / she can partially complete the movement, and 3 if he / she can complete the movement independently. A 5-year-old child with normal development is expected to score full of 88 items. The GMFM-88 was administered to the children by therapists trained in its use and tested to ensure an adequate level of competence by using a criterion test videotape
arm group label: Children with Cerebral Palsy
arm group type: Experimental
description: Aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS
intervention type: Other
intervention name: Photographic Posture Analysis
description: Postural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation. The camera was placed on a 115 cm high tripod, 1.5 m away from the subjects. Spirit levels have been adjusted so that the tripod is completely flat on the ground. The tripod was taped to the floor to maintain the same distance between the camera and the participants. Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers.
arm group label: Children with Cerebral Palsy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
last name: Nilay Çömük Balcı, Pt,PhD
role: Study Director
affiliation: Baskent University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Baskent University
investigator full name: Nilay Comuk Balci
investigator title: Pt, PhD, Associate Professor
mesh term: Paralysis
mesh term: Cerebral Palsy
sharing ipd: No