<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/NCT03306212</url>
  </required_header>
  <id_info>
    <org_study_id>KOU KAEK 2014/269</org_study_id>
    <nct_id>NCT03306212</nct_id>
  </id_info>
  <brief_title>Efficacy of Intermittent Serial Casting on Spastic Wrist Flexion Deformity</brief_title>
  <official_title>Effectiveness of Intermittent Serial Casting on Spastic Wrist Flexion Deformity in Children With Cerebral Palsy Treated By Botulinum Toxin A</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli 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>
      Spastic wrist flexion deformity is a very common problem in children with CP. Although serial&#xD;
      casting (SC) is one of the commonly used interventions in addition to botulinum toxin A&#xD;
      (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of&#xD;
      children with CP, there is limited data on SC in the upper extremity.&#xD;
&#xD;
      In this prospective, randomized, controlled clinical trial in order to overcome the issues&#xD;
      with patient compliance, side effects and combined treatment options an intermittent SC model&#xD;
      was developed. The objective of this study was to show the effects of intermittent SC when&#xD;
      combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive&#xD;
      range of motion (pROM) of children with CP having spastic wrist flexion deformity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spasticity is not only the most common motor disorder but also the main cause of slowly&#xD;
      developing secondary problems like contractures in children with cerebral palsy (CP). Spastic&#xD;
      wrist flexion deformity is a very common problem in children with CP and can be primarily due&#xD;
      to spasticity of the palmar muscle complex, can be exacerbated by the weakness of the&#xD;
      antagonist dorsiflexor muscles and can involve soft tissue and joint contractures. Although&#xD;
      serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin&#xD;
      A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of&#xD;
      children with CP, there is limited data on SC in the upper extremity. Skin irritation or&#xD;
      breakdown, painful epizodes, oedema, tendonitis, weakness, stiffness are some of the side&#xD;
      effects reported after SC. Moreover casting especially when prolonged might complicate&#xD;
      activities of daily living for instance by increasing the risk of falls or causing problems&#xD;
      in bathing. Recent evidence from literature favors early, goal oriented, activity based,&#xD;
      intensive, repetitive motor trainings in enriched environments to optimize neuroplasticity in&#xD;
      children with CP. Prolonged serial casting might also interfere with these activity based,&#xD;
      intensive rehabilitation options for upper extremity.&#xD;
&#xD;
      In this prospective, randomized, controlled clinical trial in order to overcome the issues&#xD;
      with patient compliance, side effects and combined treatment options an intermittent SC model&#xD;
      was developed. The objective of this study was to show the effects of intermittent SC when&#xD;
      combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive&#xD;
      range of motion (pROM) of children with CP having spastic wrist flexion deformity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from baseline Passive ROM</measure>
    <time_frame>12 weeks</time_frame>
    <description>Range of motion measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline MAS score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Tone measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from XV3 angle of Tardieu scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>Spasticity measurement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Casting Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients treated by botulinum toxin A and occupational therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin A</intervention_name>
    <arm_group_label>Casting Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Dysport</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Occupational Therapy</intervention_name>
    <arm_group_label>Casting Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intermittent serial casting</intervention_name>
    <arm_group_label>Casting Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having a diagnosis of CP according to Rosenbaum criteria,&#xD;
&#xD;
          -  having a unilateral spastic palmar flexion deformity of wrist joint,&#xD;
&#xD;
          -  having a Modified Ashworth Scale (MAS) score of 3 in the palmar flexor muscle complex,&#xD;
&#xD;
          -  being scheduled for BoNT-A treatment to upper extremity including palmar flexor muscle&#xD;
             group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having cognitive dysfunction,&#xD;
&#xD;
          -  having a history of orthopedic surgery to upper extremity,&#xD;
&#xD;
          -  having significant dystonia,&#xD;
&#xD;
          -  having infection skin breakdown,&#xD;
&#xD;
          -  having vascular disease,&#xD;
&#xD;
          -  having fracture or dislocation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kocaeli University</name>
      <address>
        <city>Kocaeli</city>
        <zip>41050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>March 26, 2018</last_update_submitted>
  <last_update_submitted_qc>March 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli University</investigator_affiliation>
    <investigator_full_name>Nigar Dursun</investigator_full_name>
    <investigator_title>Head of PMR Department</investigator_title>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>casting</keyword>
  <keyword>Botulinum toxin A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_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/NCT03306212
org study id: KOU KAEK 2014/269
nct id: NCT03306212
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Spastic wrist flexion deformity is a very common problem in children with CP. Although serial
      casting (SC) is one of the commonly used interventions in addition to botulinum toxin A
      (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of
      children with CP, there is limited data on SC in the upper extremity.

      In this prospective, randomized, controlled clinical trial in order to overcome the issues
      with patient compliance, side effects and combined treatment options an intermittent SC model
      was developed. The objective of this study was to show the effects of intermittent SC when
      combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive
      range of motion (pROM) of children with CP having spastic wrist flexion deformity.
Spasticity is not only the most common motor disorder but also the main cause of slowly
      developing secondary problems like contractures in children with cerebral palsy (CP). Spastic
      wrist flexion deformity is a very common problem in children with CP and can be primarily due
      to spasticity of the palmar muscle complex, can be exacerbated by the weakness of the
      antagonist dorsiflexor muscles and can involve soft tissue and joint contractures. Although
      serial casting (SC) is one of the commonly used interventions in addition to botulinum toxin
      A (BoNT-A) injections and physical therapy for spastic deformities of lower extremity of
      children with CP, there is limited data on SC in the upper extremity. Skin irritation or
      breakdown, painful epizodes, oedema, tendonitis, weakness, stiffness are some of the side
      effects reported after SC. Moreover casting especially when prolonged might complicate
      activities of daily living for instance by increasing the risk of falls or causing problems
      in bathing. Recent evidence from literature favors early, goal oriented, activity based,
      intensive, repetitive motor trainings in enriched environments to optimize neuroplasticity in
      children with CP. Prolonged serial casting might also interfere with these activity based,
      intensive rehabilitation options for upper extremity.

      In this prospective, randomized, controlled clinical trial in order to overcome the issues
      with patient compliance, side effects and combined treatment options an intermittent SC model
      was developed. The objective of this study was to show the effects of intermittent SC when
      combined with occupational therapy (OT) and BoNT-A injections on spasticity, and passive
      range of motion (pROM) of children with CP having spastic wrist flexion deformity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Mean change from baseline Passive ROM
time frame: 12 weeks
description: Range of motion measurement
measure: Mean change from baseline MAS score
time frame: 12 weeks
description: Tone measurement
measure: Mean change from XV3 angle of Tardieu scale
time frame: 12 weeks
description: Spasticity measurement
arm group label: Casting Group
arm group type: Experimental
description: Patients treated by botulinum toxin A and occupational therapy and intermittent serial casting
arm group label: Control Group
arm group type: Active Comparator
description: Patients treated by botulinum toxin A and occupational therapy
intervention type: Drug
intervention name: Botulinum toxin A
arm group label: Casting Group
arm group label: Control Group
other name: Dysport
intervention type: Other
intervention name: Occupational Therapy
arm group label: Casting Group
arm group label: Control Group
intervention type: Other
intervention name: Intermittent serial casting
arm group label: Casting Group
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli University
investigator full name: Nigar Dursun
investigator title: Head of PMR Department
mesh term: Cerebral Palsy
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No