<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/NCT04425980</url>
  </required_header>
  <id_info>
    <org_study_id>no any sponsor</org_study_id>
    <nct_id>NCT04425980</nct_id>
  </id_info>
  <brief_title>The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia</brief_title>
  <official_title>The Efficacy of Two Models of Intensive Upper Limb Training On Quality of Life in Children With Hemiplegic Cerebral Palsy Attending Regular School in Mus Province: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Muş Alparlan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Muş Alparlan 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>
      This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation&#xD;
      (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related&#xD;
      quality of life outcomes in school-aged children with cerebral palsy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 52 primary schools were screened comprehensively to determine children conforming&#xD;
      specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender,&#xD;
      affected side) and severity of functional impairment dealing with cognitive /communication,&#xD;
      manual ability and mobility were noted. After a comprehensive screening, a total of 30&#xD;
      children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups&#xD;
      (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and&#xD;
      probability. Children blinded to group allocation were delivered activity-based upper limb&#xD;
      training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training,&#xD;
      at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3&#xD;
      sessions per week was carried out in the school time (during the art or physical education&#xD;
      class), while 2 out of 3 sessions were carried out in rehabilitation centers which the&#xD;
      children regularly attend for regular care 2-day weekly. All participating children continued&#xD;
      to receive their standard care (90 minutes per week) throughout the study period.&#xD;
&#xD;
      During the 1-month screening period, physical characteristics of participants were described&#xD;
      through classification systems including The Communication Function Classification System,&#xD;
      The Manual Ability Classification System , and The Gross Motor Function Classification&#xD;
      System. Participating children were evaluated before the study entry (T1), immediately&#xD;
      postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27&#xD;
      questionnaire&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (modified constraint-induced movement therapy or Bimanual training), at an equal number and probability</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>by concealing the other allocated intervention from participants / unaware of the presence of a second intervention approach</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention</measure>
    <time_frame>From baeline to post-intervention, up to 16 weeks</time_frame>
    <description>The KIDSCREEN instruments have been established to report various subdomains of QOL about physical, emotional, mental and social well-being in school-aged children and adolescents</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hemiplegia; Congenital</condition>
  <arm_group>
    <arm_group_label>Modified Constraint-Induced Movement Therapy (test treatments)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A list of fine and motor activities consisted of the functional tasks or play activities such as school-education and sports activities, manipulative games, arts, and crafts, etc. to elicit the maximum capacity of the more affected upper limb was created according to the procedure of modified constraint-induced movement therapy (Gordon et al., 2005) and Bimanual training. In addition, specific activities were also chosen in terms of deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request. In case of activities requiring both hand use, such as stabilizing paper during the painting or holding the bricks of lego on the ground, the treating physiotherapist undertook a role as a dominant hand</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bimanual training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the Bimanual training, skilled, repetitive, and structured bimanual activities (part or whole task practice) were used to promote bimanual hand use and improve movement deficits determined before the intervention. All targeted deficits of interest were addressed within the context of the selected activity. Specifically, symmetrical bilateral movements were utilized to augment neural input from both sides. Also, meaningful activities such as buttoning and zipping-up trousers, etc. were used to ensure a transition from structured setting to real-life activities</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Modified Constraint-Induced Movement Therapy</intervention_name>
    <description>intensive use of more affected arm in structured setting</description>
    <arm_group_label>Bimanual training</arm_group_label>
    <arm_group_label>Modified Constraint-Induced Movement Therapy (test treatments)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of congenital hemiplegia,&#xD;
&#xD;
          -  Must be able to grasp objects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cerebral palsy dependent severe emotional difficulties&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hasan Bingöl, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mus Alparslan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mintaze Kerem Günel, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Halil ALKAN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mus Alparslan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mus Alparslan University</name>
      <address>
        <city>Mus</city>
        <state>Muş</state>
        <zip>49100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 5, 2021</last_update_submitted>
  <last_update_submitted_qc>March 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Muş Alparlan University</investigator_affiliation>
    <investigator_full_name>Hasan Bingöl</investigator_full_name>
    <investigator_title>Academician (Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemiplegia</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/NCT04425980
org study id: no any sponsor
nct id: NCT04425980
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation
      (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related
      quality of life outcomes in school-aged children with cerebral palsy
A total of 52 primary schools were screened comprehensively to determine children conforming
      specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender,
      affected side) and severity of functional impairment dealing with cognitive /communication,
      manual ability and mobility were noted. After a comprehensive screening, a total of 30
      children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups
      (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and
      probability. Children blinded to group allocation were delivered activity-based upper limb
      training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training,
      at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3
      sessions per week was carried out in the school time (during the art or physical education
      class), while 2 out of 3 sessions were carried out in rehabilitation centers which the
      children regularly attend for regular care 2-day weekly. All participating children continued
      to receive their standard care (90 minutes per week) throughout the study period.

      During the 1-month screening period, physical characteristics of participants were described
      through classification systems including The Communication Function Classification System,
      The Manual Ability Classification System , and The Gross Motor Function Classification
      System. Participating children were evaluated before the study entry (T1), immediately
      postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27
      questionnaire
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (modified constraint-induced movement therapy or Bimanual training), at an equal number and probability
primary purpose: Treatment
masking: Single (Participant)
masking description: by concealing the other allocated intervention from participants / unaware of the presence of a second intervention approach
measure: Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention
time frame: From baeline to post-intervention, up to 16 weeks
description: The KIDSCREEN instruments have been established to report various subdomains of QOL about physical, emotional, mental and social well-being in school-aged children and adolescents
arm group label: Modified Constraint-Induced Movement Therapy (test treatments)
arm group type: Experimental
description: A list of fine and motor activities consisted of the functional tasks or play activities such as school-education and sports activities, manipulative games, arts, and crafts, etc. to elicit the maximum capacity of the more affected upper limb was created according to the procedure of modified constraint-induced movement therapy (Gordon et al., 2005) and Bimanual training. In addition, specific activities were also chosen in terms of deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request. In case of activities requiring both hand use, such as stabilizing paper during the painting or holding the bricks of lego on the ground, the treating physiotherapist undertook a role as a dominant hand
arm group label: Bimanual training
arm group type: Active Comparator
description: For the Bimanual training, skilled, repetitive, and structured bimanual activities (part or whole task practice) were used to promote bimanual hand use and improve movement deficits determined before the intervention. All targeted deficits of interest were addressed within the context of the selected activity. Specifically, symmetrical bilateral movements were utilized to augment neural input from both sides. Also, meaningful activities such as buttoning and zipping-up trousers, etc. were used to ensure a transition from structured setting to real-life activities
intervention type: Other
intervention name: Modified Constraint-Induced Movement Therapy
description: intensive use of more affected arm in structured setting
arm group label: Bimanual training
arm group label: Modified Constraint-Induced Movement Therapy (test treatments)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hasan Bingöl, MSc
role: Principal Investigator
affiliation: Mus Alparslan University
last name: Mintaze Kerem Günel, PhD
role: Study Chair
affiliation: Hacettepe University
last name: Halil ALKAN, PhD
role: Principal Investigator
affiliation: Mus Alparslan University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Muş Alparlan University
investigator full name: Hasan Bingöl
investigator title: Academician (Lecturer
mesh term: Hemiplegia
sharing ipd: No