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/NCT06010485</url>
    </required_header>
    <id_info>
      <org_study_id>illeezozge</org_study_id>
      <nct_id>NCT06010485</nct_id>
    </id_info>
    <brief_title>The Effect of Serial Casting and Physical Therapy in Children With Idiopathic Toe Walking</brief_title>
    <official_title>The Effect of Serial Casting and Physical Therapy on Ankle Range of Motion, Toe Walking Severity, Walking Balance, Functional Health Related Quality of Life in Children With Idiopathic Toe Walking</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fatih Sultan Mehmet Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fatih Sultan Mehmet Training and Research Hospital</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>
        Children who continue to walk on their tiptoes after developing a heel-toe gait normally are&#xD;
        diagnosed with idiopathic toe walking (ITW). The study's aim was to investigate the effects&#xD;
        of serial casting and physical therapy on joint range of motion (ROM), toe walking severity,&#xD;
        functional health and health-related quality of life, walking balance, and satisfaction from&#xD;
        treatment in ITW, in comparison with the control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Children with ITW aged 3-10 years are randomized into three groups: the serial casting group&#xD;
        (n=10), the physical therapy group (n=10), and the wait-list control group (n=10). Patients&#xD;
        with ankle contracture and previous interventions are excluded. The serial casting group is&#xD;
        planned to receive intermittent serial casting once every three days for three weeks. The&#xD;
        physical therapy group is planned to undergo three sessions per week for three weeks,&#xD;
        consisting of stretching exercises, strengthening exercises, balance training, proprioception&#xD;
        exercises, and walking on heels. The patients were assessed by blinded investigators at&#xD;
        before treatment (BT), post-treatment (PT: 3th week), 1st month (1MPT), 3rd months (3MPT),&#xD;
        and 6th months post-treatment (6MPT). To ensure ethical considerations, only control group&#xD;
        was followed-up until the 1MPT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>Randomized, single blinded, controlled study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>Day 0</time_frame>
      <description>Ankle dorsiflexion ROM with extended knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>3rd week</time_frame>
      <description>Ankle dorsiflexion ROM with extended knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>7th week</time_frame>
      <description>Ankle dorsiflexion ROM with extended knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>15th week</time_frame>
      <description>Ankle dorsiflexion ROM with extended knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>27th week</time_frame>
      <description>Ankle dorsiflexion ROM with extended knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>Day 0</time_frame>
      <description>Ankle dorsiflexion ROM with flexed knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>3rd week</time_frame>
      <description>Ankle dorsiflexion ROM with flexed knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>7th week</time_frame>
      <description>Ankle dorsiflexion ROM with flexed knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>15th week</time_frame>
      <description>Ankle dorsiflexion ROM with flexed knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Range of Motion (ROM)</measure>
      <time_frame>27th week</time_frame>
      <description>Ankle dorsiflexion ROM with flexed knee</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Toe Walking Severity Scale</measure>
      <time_frame>Day 0</time_frame>
      <description>The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.&#xD;
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait &lt;10%) Stage 6: Normal heel strike</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Toe Walking Severity Scale</measure>
      <time_frame>3rd week</time_frame>
      <description>The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.&#xD;
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait &lt;10%) Stage 6: Normal heel strike</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Toe Walking Severity Scale</measure>
      <time_frame>7th week</time_frame>
      <description>The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.&#xD;
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait &lt;10%) Stage 6: Normal heel strike</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Toe Walking Severity Scale</measure>
      <time_frame>15th week</time_frame>
      <description>The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.&#xD;
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait &lt;10%) Stage 6: Normal heel strike</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Toe Walking Severity Scale</measure>
      <time_frame>27th week</time_frame>
      <description>The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.&#xD;
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait &lt;10%) Stage 6: Normal heel strike</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pediatric Outcomes Data Collection Instrument (PODCI)</measure>
      <time_frame>Day 0</time_frame>
      <description>PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Outcomes Data Collection Instrument (PODCI)</measure>
      <time_frame>3rd week</time_frame>
      <description>PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Outcomes Data Collection Instrument (PODCI)</measure>
      <time_frame>7th week</time_frame>
      <description>PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Outcomes Data Collection Instrument (PODCI)</measure>
      <time_frame>15th week</time_frame>
      <description>PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Outcomes Data Collection Instrument (PODCI)</measure>
      <time_frame>27th week</time_frame>
      <description>PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tandem Walk Test</measure>
      <time_frame>Day 0</time_frame>
      <description>The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tandem Walk Test</measure>
      <time_frame>3rd week</time_frame>
      <description>The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tandem Walk Test</measure>
      <time_frame>7th week</time_frame>
      <description>The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tandem Walk Test</measure>
      <time_frame>15th week</time_frame>
      <description>The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tandem Walk Test</measure>
      <time_frame>27th week</time_frame>
      <description>The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>3rd week</time_frame>
      <description>All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>7th week</time_frame>
      <description>All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>15th week</time_frame>
      <description>All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>27th week</time_frame>
      <description>All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Idiopathic Toe Walking</condition>
    <arm_group>
      <arm_group_label>Serial Casting</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The serial casting group received intermittent serial casting once every three days for three weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The physical therapy group underwent three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group consists of the patients on the waitlist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Serial Casting</intervention_name>
      <description>A short leg cast is applied to the serial casting group by an orthopedic specialist once every three days for three weeks.</description>
      <arm_group_label>Serial Casting</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>Stretching exercises, strengthening exercises, balance exercises, proprioception exercises, and heel walking exercises are applied to the physical therapy group for 3 weeks with a physiotherapist for 3 sessions a week.</description>
      <arm_group_label>Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 3-10 years&#xD;
  &#xD;
            2. Patients with idiopathic toe walking diagnosis&#xD;
  &#xD;
            3. To be evaluated by a pediatric neurologist, not to have abnormal findings in cranial&#xD;
               and all spinal magnetic resonance imaging and electrophysiological examinations&#xD;
               performed when deemed necessary, and creatinine kinase values are within normal limits&#xD;
               ((Absence of any neurological, orthopedic or psychiatric pathology to explain the toe&#xD;
               walking pattern (cerebral palsy, neuropathy, myopathy, autism, developmental&#xD;
               disorders, etc.)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Have previously conservative or surgical treatment&#xD;
  &#xD;
            2. Presence of plantar flexion contracture&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Esra Giray</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Esra Giray</last_name>
      <phone>+905558134394</phone>
      <email>girayesra@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Özge İlleez</last_name>
      <phone>+905326255684</phone>
      <email>ozgeilleez@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fatih Sultan Mehmet Trainig and Research Hospital</name>
        <address>
          <city>Istanbul</city>
          <zip>34752</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Pomarino D, Ramirez Llamas J, Martin S, Pomarino A. Literature Review of Idiopathic Toe Walking: Etiology, Prevalence, Classification, and Treatment. Foot Ankle Spec. 2017 Aug;10(4):337-342. doi: 10.1177/1938640016687370. Epub 2017 Jan 16.</citation>
      <PMID>28092971</PMID>
    </reference>
    <reference>
      <citation>Engelbert R, Gorter JW, Uiterwaal C, van de Putte E, Helders P. Idiopathic toe-walking in children, adolescents and young adults: a matter of local or generalised stiffness? BMC Musculoskelet Disord. 2011 Mar 21;12:61. doi: 10.1186/1471-2474-12-61.</citation>
      <PMID>21418634</PMID>
    </reference>
    <reference>
      <citation>Herrin K, Geil M. A comparison of orthoses in the treatment of idiopathic toe walking: A randomized controlled trial. Prosthet Orthot Int. 2016 Apr;40(2):262-9. doi: 10.1177/0309364614564023. Epub 2015 Jan 27.</citation>
      <PMID>25628380</PMID>
    </reference>
    <reference>
      <citation>Pomarino D, Ramirez Llamas J, Pomarino A. Idiopathic Toe Walking: Family Predisposition and Gender Distribution. Foot Ankle Spec. 2016 Oct;9(5):417-22. doi: 10.1177/1938640016656780. Epub 2016 Jul 1.</citation>
      <PMID>27370652</PMID>
    </reference>
    <reference>
      <citation>Satila H, Beilmann A, Olsen P, Helander H, Eskelinen M, Huhtala H. Does Botulinum Toxin A Treatment Enhance the Walking Pattern in Idiopathic Toe-Walking? Neuropediatrics. 2016 Jun;47(3):162-8. doi: 10.1055/s-0036-1582138. Epub 2016 Apr 18.</citation>
      <PMID>27089542</PMID>
    </reference>
    <reference>
      <citation>Engstrom P, Bartonek A, Tedroff K, Orefelt C, Haglund-Akerlind Y, Gutierrez-Farewik EM. Botulinum toxin A does not improve the results of cast treatment for idiopathic toe-walking: a randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):400-7. doi: 10.2106/JBJS.L.00889.</citation>
      <PMID>23467862</PMID>
    </reference>
    <reference>
      <citation>Williams CM, Tinley P, Curtin M. The Toe Walking Tool: a novel method for assessing idiopathic toe walking children. Gait Posture. 2010 Oct;32(4):508-11. doi: 10.1016/j.gaitpost.2010.07.011. Epub 2010 Aug 7. Erratum In: Gait Posture. 2011 Jul;34(3):442.</citation>
      <PMID>20692159</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Idiopathic Toe Walking</keyword>
    <keyword>Serial Casting</keyword>
    <keyword>Exercise</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06010485
  org study id: illeezozge
  nct id: NCT06010485
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Children who continue to walk on their tiptoes after developing a heel-toe gait normally are
        diagnosed with idiopathic toe walking (ITW). The study's aim was to investigate the effects
        of serial casting and physical therapy on joint range of motion (ROM), toe walking severity,
        functional health and health-related quality of life, walking balance, and satisfaction from
        treatment in ITW, in comparison with the control group.
  Children with ITW aged 3-10 years are randomized into three groups: the serial casting group
        (n=10), the physical therapy group (n=10), and the wait-list control group (n=10). Patients
        with ankle contracture and previous interventions are excluded. The serial casting group is
        planned to receive intermittent serial casting once every three days for three weeks. The
        physical therapy group is planned to undergo three sessions per week for three weeks,
        consisting of stretching exercises, strengthening exercises, balance training, proprioception
        exercises, and walking on heels. The patients were assessed by blinded investigators at
        before treatment (BT), post-treatment (PT: 3th week), 1st month (1MPT), 3rd months (3MPT),
        and 6th months post-treatment (6MPT). To ensure ethical considerations, only control group
        was followed-up until the 1MPT.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized, single blinded, controlled study
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Range of Motion (ROM)
  time frame: Day 0
  description: Ankle dorsiflexion ROM with extended knee
  measure: Range of Motion (ROM)
  time frame: 3rd week
  description: Ankle dorsiflexion ROM with extended knee
  measure: Range of Motion (ROM)
  time frame: 7th week
  description: Ankle dorsiflexion ROM with extended knee
  measure: Range of Motion (ROM)
  time frame: 15th week
  description: Ankle dorsiflexion ROM with extended knee
  measure: Range of Motion (ROM)
  time frame: 27th week
  description: Ankle dorsiflexion ROM with extended knee
  measure: Range of Motion (ROM)
  time frame: Day 0
  description: Ankle dorsiflexion ROM with flexed knee
  measure: Range of Motion (ROM)
  time frame: 3rd week
  description: Ankle dorsiflexion ROM with flexed knee
  measure: Range of Motion (ROM)
  time frame: 7th week
  description: Ankle dorsiflexion ROM with flexed knee
  measure: Range of Motion (ROM)
  time frame: 15th week
  description: Ankle dorsiflexion ROM with flexed knee
  measure: Range of Motion (ROM)
  time frame: 27th week
  description: Ankle dorsiflexion ROM with flexed knee
  measure: Toe Walking Severity Scale
  time frame: Day 0
  description: The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
  measure: Toe Walking Severity Scale
  time frame: 3rd week
  description: The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
  measure: Toe Walking Severity Scale
  time frame: 7th week
  description: The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
  measure: Toe Walking Severity Scale
  time frame: 15th week
  description: The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
  measure: Toe Walking Severity Scale
  time frame: 27th week
  description: The family is asked how long the child tiptoe walks during the day. The evaluation is as follows.
  Stage 1: Toe walking 76-100% of the time Stage 2: Toe walking 51-75% of the time Stage 3: Toe walking 26-50% of the time Stage 4: Toe walking 10-25% of the time Stage 5: Sole pressing but early heel lift (occasional toe gait <10%) Stage 6: Normal heel strike
  measure: Pediatric Outcomes Data Collection Instrument (PODCI)
  time frame: Day 0
  description: PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
  measure: Pediatric Outcomes Data Collection Instrument (PODCI)
  time frame: 3rd week
  description: PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
  measure: Pediatric Outcomes Data Collection Instrument (PODCI)
  time frame: 7th week
  description: PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
  measure: Pediatric Outcomes Data Collection Instrument (PODCI)
  time frame: 15th week
  description: PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
  measure: Pediatric Outcomes Data Collection Instrument (PODCI)
  time frame: 27th week
  description: PODCI evaluates functional health status through an 86 item questionnaire. Scoring varies greatly due to the multiple weighted scores of some items, scores range from 0-3 for some items and 0-6 for others. The overall score comes from 4 functional assessment scores, a global function score, and a happiness score. These scores range from 0-100 with lower scores representing higher levels of disability.
  measure: Tandem Walk Test
  time frame: Day 0
  description: The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
  measure: Tandem Walk Test
  time frame: 3rd week
  description: The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
  measure: Tandem Walk Test
  time frame: 7th week
  description: The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
  measure: Tandem Walk Test
  time frame: 15th week
  description: The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
  measure: Tandem Walk Test
  time frame: 27th week
  description: The participants are asked to walk in a straight line with one foot just in front of the other (heel to toe), arms at their sides.
  measure: Visual Analog Scale
  time frame: 3rd week
  description: All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)
  measure: Visual Analog Scale
  time frame: 7th week
  description: All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)
  measure: Visual Analog Scale
  time frame: 15th week
  description: All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)
  measure: Visual Analog Scale
  time frame: 27th week
  description: All participants are asked about satisfaction with treatment through a smiley face visual analog scale 'smiley face' visual analogue scale (0-10, 0 for full satisfaction)
  arm group label: Serial Casting
  arm group type: Active Comparator
  description: The serial casting group received intermittent serial casting once every three days for three weeks.
  arm group label: Exercise
  arm group type: Active Comparator
  description: The physical therapy group underwent three sessions per week for three weeks, consisting of stretching exercises, strengthening exercises, balance training, proprioception exercises, and walking on heels.
  arm group label: Control Group
  arm group type: No Intervention
  description: This group consists of the patients on the waitlist.
  intervention type: Other
  intervention name: Serial Casting
  description: A short leg cast is applied to the serial casting group by an orthopedic specialist once every three days for three weeks.
  arm group label: Serial Casting
  intervention type: Other
  intervention name: Exercise
  description: Stretching exercises, strengthening exercises, balance exercises, proprioception exercises, and heel walking exercises are applied to the physical therapy group for 3 weeks with a physiotherapist for 3 sessions a week.
  arm group label: Exercise
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 10 Years
  healthy volunteers: No
  last name: Esra Giray
  role: Principal Investigator
  affiliation: Fatih Sultan Mehmet training and Research Hospital, Istanbul-Turkey
  last name: Esra Giray
  phone: +905558134394
  email: girayesra@hotmail.com
  last name: Özge İlleez
  phone: +905326255684
  email: ozgeilleez@hotmail.com
  facility: 
  country: Turkey
  citation: Pomarino D, Ramirez Llamas J, Martin S, Pomarino A. Literature Review of Idiopathic Toe Walking: Etiology, Prevalence, Classification, and Treatment. Foot Ankle Spec. 2017 Aug;10(4):337-342. doi: 10.1177/1938640016687370. Epub 2017 Jan 16.
  PMID: 28092971
  citation: Engelbert R, Gorter JW, Uiterwaal C, van de Putte E, Helders P. Idiopathic toe-walking in children, adolescents and young adults: a matter of local or generalised stiffness? BMC Musculoskelet Disord. 2011 Mar 21;12:61. doi: 10.1186/1471-2474-12-61.
  PMID: 21418634
  citation: Herrin K, Geil M. A comparison of orthoses in the treatment of idiopathic toe walking: A randomized controlled trial. Prosthet Orthot Int. 2016 Apr;40(2):262-9. doi: 10.1177/0309364614564023. Epub 2015 Jan 27.
  PMID: 25628380
  citation: Pomarino D, Ramirez Llamas J, Pomarino A. Idiopathic Toe Walking: Family Predisposition and Gender Distribution. Foot Ankle Spec. 2016 Oct;9(5):417-22. doi: 10.1177/1938640016656780. Epub 2016 Jul 1.
  PMID: 27370652
  citation: Satila H, Beilmann A, Olsen P, Helander H, Eskelinen M, Huhtala H. Does Botulinum Toxin A Treatment Enhance the Walking Pattern in Idiopathic Toe-Walking? Neuropediatrics. 2016 Jun;47(3):162-8. doi: 10.1055/s-0036-1582138. Epub 2016 Apr 18.
  PMID: 27089542
  citation: Engstrom P, Bartonek A, Tedroff K, Orefelt C, Haglund-Akerlind Y, Gutierrez-Farewik EM. Botulinum toxin A does not improve the results of cast treatment for idiopathic toe-walking: a randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):400-7. doi: 10.2106/JBJS.L.00889.
  PMID: 23467862
  citation: Williams CM, Tinley P, Curtin M. The Toe Walking Tool: a novel method for assessing idiopathic toe walking children. Gait Posture. 2010 Oct;32(4):508-11. doi: 10.1016/j.gaitpost.2010.07.011. Epub 2010 Aug 7. Erratum In: Gait Posture. 2011 Jul;34(3):442.
  PMID: 20692159
  responsible party type: Sponsor
  sharing ipd: No