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/NCT06007833</url>
    </required_header>
    <id_info>
      <org_study_id>2022/3832</org_study_id>
      <nct_id>NCT06007833</nct_id>
    </id_info>
    <brief_title>Physical Therapy Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia</brief_title>
    <official_title>The Investigation of the Effects of Physical Therapy and Rehabilitation Applications on the Hip and Defined Functional Parameters in Children With Developmental Hip Dysplasia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inonu University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inonu University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study was to investigate the effects of physical therapy and rehabilitation&#xD;
        applications on the hip and defined functional parameters in children with developmental hip&#xD;
        dysplasia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Developmental dysplasia of the hip (DDH) is one of the most important factors causing&#xD;
        disability in childhood. DDH is the reason for 29% of all primary hip replacements under 60&#xD;
        years of age. The treatment of DDH, which is applied after an average of 12 months of age in&#xD;
        infants, becomes difficult due to shortening of the extra-articular soft tissues, acetabular&#xD;
        dysplasia, capsular restriction, and increased femoral anteversion. In the treatment of&#xD;
        subluxation, dislocation and residual acetabular dysplasia, many pelvic iliac osteotomies are&#xD;
        actively applied to increase joint stability and compatibility of the femur acetabulum. The&#xD;
        treatment method and physical therapy to be applied in the treatment of DDH vary depending on&#xD;
        the age and type of pathology. Therefore, osteotomies can be performed in isolation or in&#xD;
        combination with open reduction of the hip and femoral osteotomies. The general opinion about&#xD;
        the minimum patient age for iliac osteotomies (Dega osteotomy, Salter innominate) is that it&#xD;
        can be done in children who are at walking age. With Dega osteotomy, anterior, lateral and&#xD;
        mainly posterior deficiencies are eliminated by changing the acetabular inclination and&#xD;
        structure and increasing the grip between the femoral head and the acetabulum.&#xD;
  &#xD;
        In the literature, there are studies on the examination of various angular values of the hip&#xD;
        (alpha, beta, coverage angle), various classification methods, and whether the postoperative&#xD;
        follow-up of children who underwent open, closed reduction and osteotomy requires a&#xD;
        reconstructive surgical procedure. No studies have been found on the strength of the hip&#xD;
        muscles due to the application of surgical techniques in children with DDH who have weak hip,&#xD;
        chorea and lower extremity muscles due to intrauterine and structural conditions. There are&#xD;
        no studies on how the affected muscles affect the hip parameters and functional capacities of&#xD;
        children with DDH. We think that hip muscle strength, femoral head and anteversion angle,&#xD;
        acetabular index, hip adductor muscle tension are important in terms of hip stability and&#xD;
        functionality in children aged 2-5 years. Due to the lack of studies in this field in the&#xD;
        literature, this study; The aim of this study was to examine the effects of physical therapy&#xD;
        and rehabilitation practices on hip and determined functional parameters in children with&#xD;
        developmental dysplasia of the hip.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Experimental, Randomized Controlled Study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants didn't know taking which exercise treatment methods.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The Evaluation of Trunk Control</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>Trunk Control Measurement Scale, This scale, which is applied to evaluate trunk control, consists of 2 sub-headings as static sitting balance and dynamic sitting balance. The trunk control measurement scale includes a total of 15 items evaluating trunk control in children. Individuals; without back support, feet are in full contact with the ground, and hips and knees are seated in 90º flexion. In the static sitting balance subgroup (items 1-5), the patient's performance in maintaining trunk stabilization while the upper and lower extremities are in motion is evaluated. It consists of dynamic sitting balance parameters (item 6-15), selective movement control (item 6-12) and dynamic reaching subscale (item 13-15). Functional reach, which is a sub-parameter of dynamic sitting balance, is an important parameter in evaluating balance in children. Scoring of this scale varies between 0-58; A higher score indicates better trunk control.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Evaluation of the Endurance of the Spinal Stability Muscles</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>Modified &quot;Biering-Sorensen&quot; trunk extension, trunk flexion test, lateral and prone bridge test are applied to evaluate the static endurance of spinal stability muscles. The number of repetitions completed by the patients within a 30-second test interval is documented; a higher number of repetitions indicate strong performance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Evaluation of the Strength of the Spinal Stability Muscles</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>&quot;Sit-ups&quot; and Modified &quot;Push-ups&quot; tests are applied to evaluate the strength of spinal stability muscles. The number of repetitions that the patients could do for 30 seconds during the test is recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Evaluation with Radiological Imaging of Hip Parameters</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>Femoral head ossification in mm, femoral inclination angle in degrees, acetabular index developments in degrees will be examined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Assessment of Aerobic Capacity</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>The 1-min walk test is used to evaluate the walking capacity of a pediatric individual, which is defined as the maximum walking speed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Evaluation of Anaerobic Capacity</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>10m walking test is used to evaluate of anaerobic capacity. The time the child completes the 10-meter course at normal walking speed is recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Evaluation of the Dynamic Balance</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>Timed get up and go test, evaluates the dynamic balance of individuals during functional mobility; It includes components such as standing, walking and turning. The children are asked to stand up without support from the chair they are sitting in, and to return from the designated area after walking a 3-meter distance at a normal pace and sit back in the chair without support. After a trial walk, the test is repeated three times; The average of the results is recorded. At the end of the test, the time calculated with the stopwatch is noted in seconds.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Evaluation of Functional Mobility and Dynamic Balance</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>It is a simple test applied to evaluate functional mobility and dynamic balance. The child, who is standing at a height of 20 cm by the child's leg length and 30 cm away on a 10-step ladder, is told to go up and down the stairs as quickly and safely as he can.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Evaluation of Muscle Strength</measure>
      <time_frame>baseline and week 8</time_frame>
      <description>In muscle strength measurements; hip flexors, abductors, extensors, knee flexors and extensors, foot dorsiflexors and plantar flexors are evaluated. Manual Muscle Testing System (Lafayette Instrument Company, Lafayette, AB) (Lafeyette), an easy-to-carry, easy-to-use, inexpensive and portable handheld dynamometer, is used to measure maximum muscle strength for our measurements.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Exercise</condition>
    <condition>Developmental Dysplasia of the Hip</condition>
    <arm_group>
      <arm_group_label>physical therapy and rehabilitation program in addition to conservative treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Orthoses and positioning will be applied to the experimental group as a conservative treatment, following post-surgical plastering. In addition, they will receive a physical therapy and rehabilitation program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning will be applied</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Physical Therapy and Rehabilitation Modalities</intervention_name>
      <description>In the experimental group, the subjects who were taken to the physical therapy modality in addition to conventional therapy. Total, each session was performed for 60 minutes, 8 weeks, 3 days a week, under the supervision of a physiotherapist, while the other days, the family member performed 3 times a day, each movement for 3 sets, 10-15 repetitions, for a total of 60 minutes. A rest interval of less than 2 minutes was given between each set. By making use of heat modalities before starting the exercises, the elongation ability of the warmed tense structure was increased and the risk of damage in stretching exercises was reduced. The cold application was applied to the soft tissues in the extended position for 1-2 minutes with a cold pack, as the application of cold immediately after the stretching would ensure the preservation of the range of motion. Progress in the exercise program; adjusted for strength, endurance, flexibility, balance and functionality parameters.</description>
      <arm_group_label>physical therapy and rehabilitation program in addition to conservative treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Conventional Group</intervention_name>
      <description>As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning was applied.</description>
      <arm_group_label>Conventional Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  2-5 years old,&#xD;
  &#xD;
            -  Diagnosed with developmental hip dysplasia,&#xD;
  &#xD;
            -  Have not undergone any foot surgery,&#xD;
  &#xD;
            -  Not having any neurological or rheumatological disease,&#xD;
  &#xD;
            -  Having sufficient cooperation to understand and correctly apply the tests,&#xD;
  &#xD;
            -  Patients with informed consent from their families were included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having neurological problems,&#xD;
  &#xD;
            -  Meningomyelocele (diagnosed with Spina Bifida),&#xD;
  &#xD;
            -  Mental retardation and uncooperative,&#xD;
  &#xD;
            -  Children with inflammation, spasticity, spina bifida, arthrocentesis,&#xD;
  &#xD;
            -  Down syndrome-related dislocation,&#xD;
  &#xD;
            -  Children who could not obtain informed consent from their families were excluded from&#xD;
               the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>5 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elisa Calisgan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Inonu University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elisa Çalışgan, PhD</last_name>
      <phone>05342462471</phone>
      <email>elisa.calisgan@inonu.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Betül Akyol, PhD</last_name>
      <phone>05052924448</phone>
      <email>betül.akyol@inonu.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Inonu University</name>
        <address>
          <city>Malatya</city>
          <zip>44100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Elisa Çalışgan, PhD</last_name>
        <phone>05342462471</phone>
        <email>elisa.calisgan@inonu.edu.tr</email>
      </contact>
      <contact_backup>
        <last_name>Beül Akyol, PhD</last_name>
        <email>betul.akyol@inonu.edu.tr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Inonu University</investigator_affiliation>
      <investigator_full_name>Elisa Çalışgan</investigator_full_name>
      <investigator_title>The Investigation of the Effects of Physical Therapy and Rehabilitation Applications on the Hip and Defined Functional Parameters in Children with Developmental Hip Dysplasia</investigator_title>
    </responsible_party>
    <keyword>Dysplasia</keyword>
    <keyword>Hip subluxation</keyword>
    <keyword>Dislocation</keyword>
    <keyword>Rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hip Dislocation</mesh_term>
      <mesh_term>Developmental Dysplasia of the Hip</mesh_term>
      <mesh_term>Hip Dislocation, Congenital</mesh_term>
      <mesh_term>Hyperplasia</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/NCT06007833
  org study id: 2022/3832
  nct id: NCT06007833
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to investigate the effects of physical therapy and rehabilitation
        applications on the hip and defined functional parameters in children with developmental hip
        dysplasia.
  Developmental dysplasia of the hip (DDH) is one of the most important factors causing
        disability in childhood. DDH is the reason for 29% of all primary hip replacements under 60
        years of age. The treatment of DDH, which is applied after an average of 12 months of age in
        infants, becomes difficult due to shortening of the extra-articular soft tissues, acetabular
        dysplasia, capsular restriction, and increased femoral anteversion. In the treatment of
        subluxation, dislocation and residual acetabular dysplasia, many pelvic iliac osteotomies are
        actively applied to increase joint stability and compatibility of the femur acetabulum. The
        treatment method and physical therapy to be applied in the treatment of DDH vary depending on
        the age and type of pathology. Therefore, osteotomies can be performed in isolation or in
        combination with open reduction of the hip and femoral osteotomies. The general opinion about
        the minimum patient age for iliac osteotomies (Dega osteotomy, Salter innominate) is that it
        can be done in children who are at walking age. With Dega osteotomy, anterior, lateral and
        mainly posterior deficiencies are eliminated by changing the acetabular inclination and
        structure and increasing the grip between the femoral head and the acetabulum.
  
        In the literature, there are studies on the examination of various angular values of the hip
        (alpha, beta, coverage angle), various classification methods, and whether the postoperative
        follow-up of children who underwent open, closed reduction and osteotomy requires a
        reconstructive surgical procedure. No studies have been found on the strength of the hip
        muscles due to the application of surgical techniques in children with DDH who have weak hip,
        chorea and lower extremity muscles due to intrauterine and structural conditions. There are
        no studies on how the affected muscles affect the hip parameters and functional capacities of
        children with DDH. We think that hip muscle strength, femoral head and anteversion angle,
        acetabular index, hip adductor muscle tension are important in terms of hip stability and
        functionality in children aged 2-5 years. Due to the lack of studies in this field in the
        literature, this study; The aim of this study was to examine the effects of physical therapy
        and rehabilitation practices on hip and determined functional parameters in children with
        developmental dysplasia of the hip.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Experimental, Randomized Controlled Study
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Participants didn't know taking which exercise treatment methods.
  measure: The Evaluation of Trunk Control
  time frame: baseline and week 8
  description: Trunk Control Measurement Scale, This scale, which is applied to evaluate trunk control, consists of 2 sub-headings as static sitting balance and dynamic sitting balance. The trunk control measurement scale includes a total of 15 items evaluating trunk control in children. Individuals; without back support, feet are in full contact with the ground, and hips and knees are seated in 90º flexion. In the static sitting balance subgroup (items 1-5), the patient's performance in maintaining trunk stabilization while the upper and lower extremities are in motion is evaluated. It consists of dynamic sitting balance parameters (item 6-15), selective movement control (item 6-12) and dynamic reaching subscale (item 13-15). Functional reach, which is a sub-parameter of dynamic sitting balance, is an important parameter in evaluating balance in children. Scoring of this scale varies between 0-58; A higher score indicates better trunk control.
  measure: The Evaluation of the Endurance of the Spinal Stability Muscles
  time frame: baseline and week 8
  description: Modified "Biering-Sorensen" trunk extension, trunk flexion test, lateral and prone bridge test are applied to evaluate the static endurance of spinal stability muscles. The number of repetitions completed by the patients within a 30-second test interval is documented; a higher number of repetitions indicate strong performance.
  measure: The Evaluation of the Strength of the Spinal Stability Muscles
  time frame: baseline and week 8
  description: "Sit-ups" and Modified "Push-ups" tests are applied to evaluate the strength of spinal stability muscles. The number of repetitions that the patients could do for 30 seconds during the test is recorded.
  measure: The Evaluation with Radiological Imaging of Hip Parameters
  time frame: baseline and week 8
  description: Femoral head ossification in mm, femoral inclination angle in degrees, acetabular index developments in degrees will be examined.
  measure: The Assessment of Aerobic Capacity
  time frame: baseline and week 8
  description: The 1-min walk test is used to evaluate the walking capacity of a pediatric individual, which is defined as the maximum walking speed.
  measure: The Evaluation of Anaerobic Capacity
  time frame: baseline and week 8
  description: 10m walking test is used to evaluate of anaerobic capacity. The time the child completes the 10-meter course at normal walking speed is recorded.
  measure: The Evaluation of the Dynamic Balance
  time frame: baseline and week 8
  description: Timed get up and go test, evaluates the dynamic balance of individuals during functional mobility; It includes components such as standing, walking and turning. The children are asked to stand up without support from the chair they are sitting in, and to return from the designated area after walking a 3-meter distance at a normal pace and sit back in the chair without support. After a trial walk, the test is repeated three times; The average of the results is recorded. At the end of the test, the time calculated with the stopwatch is noted in seconds.
  measure: The Evaluation of Functional Mobility and Dynamic Balance
  time frame: baseline and week 8
  description: It is a simple test applied to evaluate functional mobility and dynamic balance. The child, who is standing at a height of 20 cm by the child's leg length and 30 cm away on a 10-step ladder, is told to go up and down the stairs as quickly and safely as he can.
  measure: The Evaluation of Muscle Strength
  time frame: baseline and week 8
  description: In muscle strength measurements; hip flexors, abductors, extensors, knee flexors and extensors, foot dorsiflexors and plantar flexors are evaluated. Manual Muscle Testing System (Lafayette Instrument Company, Lafayette, AB) (Lafeyette), an easy-to-carry, easy-to-use, inexpensive and portable handheld dynamometer, is used to measure maximum muscle strength for our measurements.
  arm group label: physical therapy and rehabilitation program in addition to conservative treatment
  arm group type: Experimental
  description: Orthoses and positioning will be applied to the experimental group as a conservative treatment, following post-surgical plastering. In addition, they will receive a physical therapy and rehabilitation program
  arm group label: Conventional Group
  arm group type: Active Comparator
  description: As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning will be applied
  intervention type: Behavioral
  intervention name: Physical Therapy and Rehabilitation Modalities
  description: In the experimental group, the subjects who were taken to the physical therapy modality in addition to conventional therapy. Total, each session was performed for 60 minutes, 8 weeks, 3 days a week, under the supervision of a physiotherapist, while the other days, the family member performed 3 times a day, each movement for 3 sets, 10-15 repetitions, for a total of 60 minutes. A rest interval of less than 2 minutes was given between each set. By making use of heat modalities before starting the exercises, the elongation ability of the warmed tense structure was increased and the risk of damage in stretching exercises was reduced. The cold application was applied to the soft tissues in the extended position for 1-2 minutes with a cold pack, as the application of cold immediately after the stretching would ensure the preservation of the range of motion. Progress in the exercise program; adjusted for strength, endurance, flexibility, balance and functionality parameters.
  arm group label: physical therapy and rehabilitation program in addition to conservative treatment
  intervention type: Behavioral
  intervention name: Conventional Group
  description: As a conservative treatment in the control group, post-surgical plastering followed by orthoses and positioning was applied.
  arm group label: Conventional Group
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 5 Years
  healthy volunteers: No
  last name: Elisa Calisgan, PhD
  role: Principal Investigator
  affiliation: Inonu University
  last name: Elisa Çalışgan, PhD
  phone: 05342462471
  email: elisa.calisgan@inonu.edu.tr
  last name: Betül Akyol, PhD
  phone: 05052924448
  email: betül.akyol@inonu.edu.tr
  facility: 
  contact: 
  contact backup: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Inonu University
  investigator full name: Elisa Çalışgan
  investigator title: The Investigation of the Effects of Physical Therapy and Rehabilitation Applications on the Hip and Defined Functional Parameters in Children with Developmental Hip Dysplasia
  mesh term: Hip Dislocation
  mesh term: Developmental Dysplasia of the Hip
  mesh term: Hip Dislocation, Congenital
  mesh term: Hyperplasia