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/NCT05962749</url>
    </required_header>
    <id_info>
      <org_study_id>2023-743</org_study_id>
      <nct_id>NCT05962749</nct_id>
    </id_info>
    <brief_title>The Relationship of Forward and Backward Walking With Selective Motor Control, Trunk Control and Balance in Children With Cerebral Palsy</brief_title>
    <official_title>The Relationship of Forward and Backward Walking With Selective Motor Control, Trunk Control and Balance in Children With Cerebral Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alanya Alaaddin Keykubat University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alanya Alaaddin Keykubat 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>
        Cerebral palsy (CP) is defined as a disorder of the developing brain that causes movement&#xD;
        disorders and may be associated with other neurologically based disorders. Gait abnormalities&#xD;
        are a direct result of damage to the motor areas of the brain and include symptoms such as&#xD;
        spasticity, dystonia, weakness, loss of selective muscle control, dependence on primitive&#xD;
        reflexes, abnormal muscle and inadequate balance reactions.&#xD;
  &#xD;
        Walking backwards during activities of daily living is as important as walking forward. Some&#xD;
        of these activities are stepping back towards the chair, stepping back when opening the door&#xD;
        and pulling the door, reflexively leaning back when suddenly encountering an obstacle or&#xD;
        uneven ground. In addition, backward walking is defined as a more complex activity that&#xD;
        requires more neuromuscular control, proprioception sense, and protective reflex activation&#xD;
        than forward walking.&#xD;
  &#xD;
        Selective motor control is an essential part of typical human movement, allowing for smooth&#xD;
        and discrete control of joint movement. Impaired selective motor control causes abnormal&#xD;
        reciprocal muscle activations or involuntary combined movements, leading to difficulties with&#xD;
        coordination, balance, walking efficiency, and symmetry. Impaired selective motor control is&#xD;
        associated with poor gross motor function and balance control, severe general gait&#xD;
        deviations, and decreased walking speed.&#xD;
  &#xD;
        The aim of this study is to examine the relationship between forward and backward walking and&#xD;
        selective motor control, trunk control and balance in children with cerebral palsy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 20, 2023</start_date>
    <completion_date type="Anticipated">December 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 29, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>3 meter backward walk test (3MBWT)</measure>
      <time_frame>First day</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>10 meter walk test (10MWT)</measure>
      <time_frame>First day</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Selective Control Assessment of the Lower Extremities (SCALE)</measure>
      <time_frame>First day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trunk Control Measurement Scale (TCMS)</measure>
      <time_frame>First day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Balance Scale (PBS)</measure>
      <time_frame>First day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Independence Measure for Children (WeeFIM)</measure>
      <time_frame>First day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Ashworth Scale (MAS)</measure>
      <time_frame>First day</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Cerebral Palsy</condition>
    <condition>Balance</condition>
    <condition>Gait Disorders in Children</condition>
    <arm_group>
      <arm_group_label>Children With Cerebral Palsy</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Assessment</intervention_name>
      <description>3 meter backward walk test (3MBWT), 10 meter walk test (10MWT), Selective Control Assessment of the Lower Extremities (SCALE), Trunk Control Measurement Scale (TCMS), Pediatric Balance Scale (PBS), Functional Independence Measure for Children (WeeFIM), Modified Ashworth Scale (MAS)</description>
      <arm_group_label>Children With Cerebral Palsy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children who apply for rehabilitation in Special Education and Rehabilitation Centers&#xD;
          affiliated to the Ministry of National Education in the city of Antalya will be included in&#xD;
          the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To be diagnosed with cerebral palsy by a specialist physician&#xD;
  &#xD;
            -  Gross Motor Function Classification System (GMFCS) level I or II&#xD;
  &#xD;
            -  Children with lower extremity muscles level ≤ 2 according to the Modified Ashworth&#xD;
               Scale (MAS)&#xD;
  &#xD;
            -  Ability to follow verbal commands&#xD;
  &#xD;
            -  Modified Ashworth Scale (MAS) Level ≤2&#xD;
  &#xD;
            -  Complete passive range of motion in the ankle and knee joints&#xD;
  &#xD;
            -  Agree to participate in the study (with parent and child consent)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having had Botox (Botulinum toxin) or a surgical operation in the last 6 months&#xD;
  &#xD;
            -  Having contractures in the ankle and knee joints that affect walking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ebru Keklikci</last_name>
      <phone>+90 242 510 61 45</phone>
      <email>ebru.keklikci@alanya.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gökhan Yazıcı</last_name>
      <email>gokhanyazici38@gmail.com</email>
    </overall_contact_backup>
    <results_reference>
      <citation>Gage JR, Novacheck TF. An update on the treatment of gait problems in cerebral palsy. J Pediatr Orthop B. 2001 Oct;10(4):265-74.</citation>
      <PMID>11727367</PMID>
    </results_reference>
    <results_reference>
      <citation>Raffegeau TE, Kellaher GK, Terza MJ, Roper JA, Altmann LJ, Hass CJ. Older women take shorter steps during backwards walking and obstacle crossing. Exp Gerontol. 2019 Jul 15;122:60-66. doi: 10.1016/j.exger.2019.04.011. Epub 2019 Apr 26.</citation>
      <PMID>31034865</PMID>
    </results_reference>
    <results_reference>
      <citation>Teo TWL, Mong Y, Ng SSM (2013) The repetitive Five-Times-Sit-To-Stand test: its reliability in older adults. Int J Ther Rehabil 20(3):122-130</citation>
    </results_reference>
    <results_reference>
      <citation>Cahill-Rowley K, Rose J. Etiology of impaired selective motor control: emerging evidence and its implications for research and treatment in cerebral palsy. Dev Med Child Neurol. 2014 Jun;56(6):522-8. doi: 10.1111/dmcn.12355. Epub 2013 Dec 21.</citation>
      <PMID>24359183</PMID>
    </results_reference>
    <results_reference>
      <citation>Rumberg F, Bakir MS, Taylor WR, Haberl H, Sarpong A, Sharankou I, Lebek S, Funk JF. The Effects of Selective Dorsal Rhizotomy on Balance and Symmetry of Gait in Children with Cerebral Palsy. PLoS One. 2016 Apr 4;11(4):e0152930. doi: 10.1371/journal.pone.0152930. eCollection 2016. Erratum In: PLoS One. 2017 May 8;12 (5):e0177585.</citation>
      <PMID>27043310</PMID>
    </results_reference>
    <results_reference>
      <citation>Fowler EG, Goldberg EJ. The effect of lower extremity selective voluntary motor control on interjoint coordination during gait in children with spastic diplegic cerebral palsy. Gait Posture. 2009 Jan;29(1):102-7. doi: 10.1016/j.gaitpost.2008.07.007. Epub 2008 Sep 10.</citation>
      <PMID>18786827</PMID>
    </results_reference>
    <results_reference>
      <citation>Yun G, Huang M, Cao J, Hu X. Selective motor control correlates with gross motor ability, functional balance and gait performance in ambulant children with bilateral spastic cerebral palsy. Gait Posture. 2023 Jan;99:9-13. doi: 10.1016/j.gaitpost.2022.10.009. Epub 2022 Oct 19.</citation>
      <PMID>36283302</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alanya Alaaddin Keykubat University</investigator_affiliation>
      <investigator_full_name>Ebru Keklikci</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>Cerebral Palsy</keyword>
    <keyword>Backward Walking</keyword>
    <keyword>Selective Motor Control</keyword>
    <keyword>Trunk Control</keyword>
    <keyword>Balance</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>
  
  
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/NCT05962749
  org study id: 2023-743
  nct id: NCT05962749
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cerebral palsy (CP) is defined as a disorder of the developing brain that causes movement
        disorders and may be associated with other neurologically based disorders. Gait abnormalities
        are a direct result of damage to the motor areas of the brain and include symptoms such as
        spasticity, dystonia, weakness, loss of selective muscle control, dependence on primitive
        reflexes, abnormal muscle and inadequate balance reactions.
  
        Walking backwards during activities of daily living is as important as walking forward. Some
        of these activities are stepping back towards the chair, stepping back when opening the door
        and pulling the door, reflexively leaning back when suddenly encountering an obstacle or
        uneven ground. In addition, backward walking is defined as a more complex activity that
        requires more neuromuscular control, proprioception sense, and protective reflex activation
        than forward walking.
  
        Selective motor control is an essential part of typical human movement, allowing for smooth
        and discrete control of joint movement. Impaired selective motor control causes abnormal
        reciprocal muscle activations or involuntary combined movements, leading to difficulties with
        coordination, balance, walking efficiency, and symmetry. Impaired selective motor control is
        associated with poor gross motor function and balance control, severe general gait
        deviations, and decreased walking speed.
  
        The aim of this study is to examine the relationship between forward and backward walking and
        selective motor control, trunk control and balance in children with cerebral palsy.
  observational model: Other
  time perspective: Cross-Sectional
  measure: 3 meter backward walk test (3MBWT)
  time frame: First day
  measure: 10 meter walk test (10MWT)
  time frame: First day
  measure: Selective Control Assessment of the Lower Extremities (SCALE)
  time frame: First day
  measure: Trunk Control Measurement Scale (TCMS)
  time frame: First day
  measure: Pediatric Balance Scale (PBS)
  time frame: First day
  measure: Functional Independence Measure for Children (WeeFIM)
  time frame: First day
  measure: Modified Ashworth Scale (MAS)
  time frame: First day
  arm group label: Children With Cerebral Palsy
  intervention type: Other
  intervention name: Assessment
  description: 3 meter backward walk test (3MBWT), 10 meter walk test (10MWT), Selective Control Assessment of the Lower Extremities (SCALE), Trunk Control Measurement Scale (TCMS), Pediatric Balance Scale (PBS), Functional Independence Measure for Children (WeeFIM), Modified Ashworth Scale (MAS)
  arm group label: Children With Cerebral Palsy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Ebru Keklikci
  phone: +90 242 510 61 45
  email: ebru.keklikci@alanya.edu.tr
  last name: Gökhan Yazıcı
  email: gokhanyazici38@gmail.com
  citation: Gage JR, Novacheck TF. An update on the treatment of gait problems in cerebral palsy. J Pediatr Orthop B. 2001 Oct;10(4):265-74.
  PMID: 11727367
  citation: Raffegeau TE, Kellaher GK, Terza MJ, Roper JA, Altmann LJ, Hass CJ. Older women take shorter steps during backwards walking and obstacle crossing. Exp Gerontol. 2019 Jul 15;122:60-66. doi: 10.1016/j.exger.2019.04.011. Epub 2019 Apr 26.
  PMID: 31034865
  citation: Teo TWL, Mong Y, Ng SSM (2013) The repetitive Five-Times-Sit-To-Stand test: its reliability in older adults. Int J Ther Rehabil 20(3):122-130
  citation: Cahill-Rowley K, Rose J. Etiology of impaired selective motor control: emerging evidence and its implications for research and treatment in cerebral palsy. Dev Med Child Neurol. 2014 Jun;56(6):522-8. doi: 10.1111/dmcn.12355. Epub 2013 Dec 21.
  PMID: 24359183
  citation: Rumberg F, Bakir MS, Taylor WR, Haberl H, Sarpong A, Sharankou I, Lebek S, Funk JF. The Effects of Selective Dorsal Rhizotomy on Balance and Symmetry of Gait in Children with Cerebral Palsy. PLoS One. 2016 Apr 4;11(4):e0152930. doi: 10.1371/journal.pone.0152930. eCollection 2016. Erratum In: PLoS One. 2017 May 8;12 (5):e0177585.
  PMID: 27043310
  citation: Fowler EG, Goldberg EJ. The effect of lower extremity selective voluntary motor control on interjoint coordination during gait in children with spastic diplegic cerebral palsy. Gait Posture. 2009 Jan;29(1):102-7. doi: 10.1016/j.gaitpost.2008.07.007. Epub 2008 Sep 10.
  PMID: 18786827
  citation: Yun G, Huang M, Cao J, Hu X. Selective motor control correlates with gross motor ability, functional balance and gait performance in ambulant children with bilateral spastic cerebral palsy. Gait Posture. 2023 Jan;99:9-13. doi: 10.1016/j.gaitpost.2022.10.009. Epub 2022 Oct 19.
  PMID: 36283302
  responsible party type: Principal Investigator
  investigator affiliation: Alanya Alaaddin Keykubat University
  investigator full name: Ebru Keklikci
  investigator title: Research Assistant
  mesh term: Paralysis
  mesh term: Cerebral Palsy
  sharing ipd: No