<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/NCT03037697</url>
  </required_header>
  <id_info>
    <org_study_id>Umm Al-Qura University</org_study_id>
    <nct_id>NCT03037697</nct_id>
  </id_info>
  <brief_title>Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy</brief_title>
  <official_title>Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umm Al-Qura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umm Al-Qura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and&#xD;
      strapping system on increasing axial stability that will reflect on improving balance and&#xD;
      walking performance in children with dyskinetic cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and&#xD;
      strapping system on increasing axial stability that will reflect on improving balance and&#xD;
      walking performance in children with dyskinetic cerebral palsy. Forty children with&#xD;
      dyskinetic CP will be assigned randomly into two groups (A &amp; B). Control group (A) will&#xD;
      receive conventional rehabilitation program for postural correction 2 hours/3 sessions&#xD;
      weekly/3 successive months. Study group (B) will receive conventional rehabilitation program&#xD;
      as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients&#xD;
      evaluation will be carried out before and after the intervention programs to assess gait and&#xD;
      balance performance using Noraxons myo pressure plate and Biodex balance system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline gait parameters at 3 months</measure>
    <time_frame>Baseline and 3 months post-intervention</time_frame>
    <description>Gait parameters will be evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline postural stability at 3 months</measure>
    <time_frame>Baseline and 3 months post-intervention</time_frame>
    <description>Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>TheraTogs Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TheraTogs Arm The participating children will wear TheraTogs orthotic undergarment and strapping as preparatory stage without application of any exercise program with gradually increasing the worn time till reaching the 8 hours per day, to allow the children to become acclimated to the system+ Traditional treatment 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Treatment Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional Treatment Arm&#xD;
1-Trunk control exercises 2-Core stability training 3-Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board&#xD;
3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TheraTogs Arm</intervention_name>
    <description>TheraTogs Arm Received Soft Orthotic undergarments</description>
    <arm_group_label>TheraTogs Arm</arm_group_label>
    <other_name>Experimental</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Treatment</intervention_name>
    <description>Traditional treatment to Dyskinetic CP&#xD;
1- Trunk control exercises 2- Core stability training 3- Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board</description>
    <arm_group_label>TheraTogs Arm</arm_group_label>
    <arm_group_label>Traditional Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The levels of gross motor function will be selected between levels I and II according&#xD;
             to Gross Motor Function Classification System (GMFCS); have the ability to walk 10 m&#xD;
             independently without an orthosis; should be cognitively competent and able to&#xD;
             understand and follow instructions; height will be more than 100 cm to fit with the&#xD;
             Biodex balance equipment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If participants use an assistive mobility device; GMFCS levels III, IV, and V; fixed&#xD;
             contractures of lower limb musculature; hip dislocation; significant spinal&#xD;
             deformities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shamekh M El-Shamy, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maternity and Children Hospital</name>
      <address>
        <city>Mecca</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>February 25, 2021</last_update_submitted>
  <last_update_submitted_qc>February 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umm Al-Qura University</investigator_affiliation>
    <investigator_full_name>Shamekh Mohamed El-Shamy</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037697
org study id: Umm Al-Qura University
nct id: NCT03037697
lead sponsor: 
has dmc: Yes
The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and
      strapping system on increasing axial stability that will reflect on improving balance and
      walking performance in children with dyskinetic cerebral palsy.
The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and
      strapping system on increasing axial stability that will reflect on improving balance and
      walking performance in children with dyskinetic cerebral palsy. Forty children with
      dyskinetic CP will be assigned randomly into two groups (A & B). Control group (A) will
      receive conventional rehabilitation program for postural correction 2 hours/3 sessions
      weekly/3 successive months. Study group (B) will receive conventional rehabilitation program
      as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients
      evaluation will be carried out before and after the intervention programs to assess gait and
      balance performance using Noraxons myo pressure plate and Biodex balance system.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change from baseline gait parameters at 3 months
time frame: Baseline and 3 months post-intervention
description: Gait parameters will be evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).
measure: Change from baseline postural stability at 3 months
time frame: Baseline and 3 months post-intervention
description: Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).
arm group label: TheraTogs Arm
arm group type: Experimental
description: TheraTogs Arm The participating children will wear TheraTogs orthotic undergarment and strapping as preparatory stage without application of any exercise program with gradually increasing the worn time till reaching the 8 hours per day, to allow the children to become acclimated to the system+ Traditional treatment 3 months
arm group label: Traditional Treatment Arm
arm group type: Active Comparator
description: Traditional Treatment Arm
1-Trunk control exercises 2-Core stability training 3-Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board
3 months
intervention type: Other
intervention name: TheraTogs Arm
description: TheraTogs Arm Received Soft Orthotic undergarments
arm group label: TheraTogs Arm
other name: Experimental
intervention type: Other
intervention name: Traditional Treatment
description: Traditional treatment to Dyskinetic CP
1- Trunk control exercises 2- Core stability training 3- Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board
arm group label: TheraTogs Arm
arm group label: Traditional Treatment Arm
criteria: 
gender: All
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: No
last name: Shamekh M El-Shamy, Ph.D
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Umm Al-Qura University
investigator full name: Shamekh Mohamed El-Shamy
investigator title: Associate Professor
mesh term: Cerebral Palsy
sharing ipd: No