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/NCT06021899</url>
    </required_header>
    <id_info>
      <org_study_id>YIRS/007</org_study_id>
      <nct_id>NCT06021899</nct_id>
    </id_info>
    <brief_title>Effects of Classic and Modified CIMT on Quality of Life of Children With Hemiplegic CP</brief_title>
    <acronym>CIMT</acronym>
    <official_title>Effects of Classic Constraint Induced Movement Therapy and Its Modified Form on Quality of Life of Children With Hemiplegic Cerebral Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Health Education Research Foundation (HERF)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Health Education Research Foundation (HERF)</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>
        The purpose of this research is to see the effect of classic constraint-induced movement&#xD;
        therapy and its modified form on quality of life of children with hemiplegic cerebral palsy.&#xD;
        Randomized controlled trials with 2-3 weeks follow-up. The sample size is 40. The subjects&#xD;
        are divided in two groups, 20 subjects in classical CIMT group and 20 in modified CIMT group.&#xD;
        Study duration is of 6 months. Sampling technique applied will be purposive non probability&#xD;
        sampling technique. Only 4-12 years individual with hemiplegic cerebral palsy are included.&#xD;
        Tools used in the study are Cerebral palsy (quality of life) and Kid Screen 27.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Both CCIMT and MCIMT are effective treatments to improve quality of life of children with CP.&#xD;
        However conflicting evidence is present on which one of these is more effective and no final&#xD;
        conclusion can be made to date. This study intends to add to the literature and contribute in&#xD;
        reaching final conclusion about the superiority of either intervention. The purpose of this&#xD;
        study was to see the psychosocial effect (quality of life) of CIMT and its modified form on&#xD;
        HCP&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2018</start_date>
    <completion_date type="Actual">January 1, 2019</completion_date>
    <primary_completion_date type="Actual">December 30, 2018</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cerebral Palsy Quality of Life CP(QOL)</measure>
      <time_frame>3 weeks.</time_frame>
      <description>The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the first health condition-specific questionnaire designed for measuring QOL in children with cerebral palsy (CP) aged 4-12 years. CP QOL Questionnaires measure include : Social wellbeing &amp; acceptance, Feelings about functioning, Participation &amp; physical health, Emotional wellbeing &amp; self-esteem, Access to services, Pain &amp; impact of disability, Family health</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Kid Screen 27</measure>
      <time_frame>3 weeks</time_frame>
      <description>The KIDSCREEN-27 was developed as a shorter version of the KIDSCREEN-52 with a minimum of information loss and with good psychometric properties. The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy &amp; Parents (7 items), Peers &amp; Social Support (4 items), and School Environment (4 items)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Hemiplegic Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>Classic CIMT group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Total session of 6 hours a day, 5 days per week for 3 weeks to Classic CIMT groups will be given.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mCIMT group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Session of 6 hours a day, 5 session per week for first 2 weeks (CIMT), session of 2 hours a day, 5 days per week for last 1 week (BIT) to modified CIMT group will be given.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>modified constraint induced movement therapy</intervention_name>
      <description>Modified CIMT protocol that was based on suggestions made by Dromerick, Edwards, and Hahn (2000) . Modifications were reductions in the duration of mitt wear and massed practice compared with the traditional protocol</description>
      <arm_group_label>Classic CIMT group</arm_group_label>
      <arm_group_label>mCIMT group</arm_group_label>
      <other_name>classic constaint induced movement therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  4 to 12 years CP with unilateral, bilateral or severely asymmetrical impairment Manual&#xD;
               Ability Classification System(MACS) I, II or III Wrist extension capacity at least&#xD;
               20°; fingers with 10° of complete flexion Children able to follow Command&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children also having disabilities other than Cerebral palsy Contractures that&#xD;
               significantly limit functional arm use. Children with MR&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Saad Tariq, master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Yusra Institute of Rehablitation Science</name>
        <address>
          <city>Islamabad</city>
          <zip>45400</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Health Education Research Foundation (HERF)</investigator_affiliation>
      <investigator_full_name>Mamoona Tasleem Afzal</investigator_full_name>
      <investigator_title>Mamoona Tasleem Afzal</investigator_title>
    </responsible_party>
    <keyword>Constraint induced movement therapy</keyword>
    <keyword>Cerebral palsy</keyword>
    <keyword>CPQOL</keyword>
    <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>
  
  
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/NCT06021899
  org study id: YIRS/007
  nct id: NCT06021899
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research is to see the effect of classic constraint-induced movement
        therapy and its modified form on quality of life of children with hemiplegic cerebral palsy.
        Randomized controlled trials with 2-3 weeks follow-up. The sample size is 40. The subjects
        are divided in two groups, 20 subjects in classical CIMT group and 20 in modified CIMT group.
        Study duration is of 6 months. Sampling technique applied will be purposive non probability
        sampling technique. Only 4-12 years individual with hemiplegic cerebral palsy are included.
        Tools used in the study are Cerebral palsy (quality of life) and Kid Screen 27.
  Both CCIMT and MCIMT are effective treatments to improve quality of life of children with CP.
        However conflicting evidence is present on which one of these is more effective and no final
        conclusion can be made to date. This study intends to add to the literature and contribute in
        reaching final conclusion about the superiority of either intervention. The purpose of this
        study was to see the psychosocial effect (quality of life) of CIMT and its modified form on
        HCP
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Cerebral Palsy Quality of Life CP(QOL)
  time frame: 3 weeks.
  description: The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the first health condition-specific questionnaire designed for measuring QOL in children with cerebral palsy (CP) aged 4-12 years. CP QOL Questionnaires measure include : Social wellbeing & acceptance, Feelings about functioning, Participation & physical health, Emotional wellbeing & self-esteem, Access to services, Pain & impact of disability, Family health
  measure: Kid Screen 27
  time frame: 3 weeks
  description: The KIDSCREEN-27 was developed as a shorter version of the KIDSCREEN-52 with a minimum of information loss and with good psychometric properties. The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy & Parents (7 items), Peers & Social Support (4 items), and School Environment (4 items)
  arm group label: Classic CIMT group
  arm group type: Active Comparator
  description: Total session of 6 hours a day, 5 days per week for 3 weeks to Classic CIMT groups will be given.
  arm group label: mCIMT group
  arm group type: Experimental
  description: Session of 6 hours a day, 5 session per week for first 2 weeks (CIMT), session of 2 hours a day, 5 days per week for last 1 week (BIT) to modified CIMT group will be given.
  intervention type: Other
  intervention name: modified constraint induced movement therapy
  description: Modified CIMT protocol that was based on suggestions made by Dromerick, Edwards, and Hahn (2000) . Modifications were reductions in the duration of mitt wear and massed practice compared with the traditional protocol
  arm group label: Classic CIMT group
  arm group label: mCIMT group
  other name: classic constaint induced movement therapy
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Saad Tariq, master
  role: Principal Investigator
  affiliation: Riphah International University
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Health Education Research Foundation (HERF)
  investigator full name: Mamoona Tasleem Afzal
  investigator title: Mamoona Tasleem Afzal
  mesh term: Cerebral Palsy
  sharing ipd: No