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/NCT05981287</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/22/0720</org_study_id>
      <nct_id>NCT05981287</nct_id>
    </id_info>
    <brief_title>Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training.</brief_title>
    <official_title>Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training on Balance, Trunk Control and Functional Mobility in Children With Cerebral Palsy.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International 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>
        This study aims to find the comparison of task oriented activity based neurodevelopmental&#xD;
        principles and gross motor task training on balance, trunk control and functional mobility in&#xD;
        children with cerebral palsy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cerebral palsy (CP) being a non-progressive neurodevelopmental condition, is the leading&#xD;
        cause of chronic disability in children, making them physically and mentally handicapped and&#xD;
        socially unapproachable. The low tone of the torso also causes postural instability, lack of&#xD;
        mobility, and muscle stiffness in the legs. Therapeutic intervention for children with&#xD;
        cerebral palsy should be composed of goal directed, functional, and meaningful activities by&#xD;
        considering the clinical type, degree of disability, cognitive level and interest of the&#xD;
        child. The trunk being the central key point of the body, proximal trunk control is a&#xD;
        prerequisite for distal limb movement control, balance, and functional mobility. Since&#xD;
        children with cerebral palsy show damage not only in the function and an ability to&#xD;
        accomplish tasks, but also in the quality of movement. The objective of this study will be to&#xD;
        help clinicians regarding the effectiveness of task-oriented training and gross motor&#xD;
        functional training for children with cerebral palsy.&#xD;
  &#xD;
        This will be a Randomized Clinical Trial in which participants of age 5 - 12 years with&#xD;
        cerebral palsy will be assigned randomly for the study. Population will be taken from&#xD;
        Physical Therapy Department of Agile Rehabilitation Complex, Bahawalpur. After taking&#xD;
        consent, demographics including age, gender and birth history etc. will be recorded.&#xD;
        Questionnaires will be distributed among parents and their responses will be collected.&#xD;
        Questionnaires for trunk impairment scale, postural assessment scale, pediatric balance scale&#xD;
        and GMFM-88 will be used as tools of assessment. The collected data will be analyzed in&#xD;
        Statistical Package for the Social Sciences (SPSS) 27.0.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 15, 2022</start_date>
    <completion_date type="Actual">April 5, 2023</completion_date>
    <primary_completion_date type="Actual">March 5, 2023</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pediatric Balance Scale - PBS</measure>
      <time_frame>2 months</time_frame>
      <description>Pediatric balance scale is an outcome measurement tool used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Trunk Control Measurement Scale - TCMS</measure>
      <time_frame>2 months</time_frame>
      <description>Trunk Control Measurement Scale is the clinical tool to measure trunk control in children with cerebral palsy. Control of muscles is necessary to maintain stability around the trunk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gross Motor Function Measure 88 - GMFM 88</measure>
      <time_frame>2 months</time_frame>
      <description>The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66). The scoring system of the GMFM is a four-point scale that consists of 66 items divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group undergo conventional physical therapy and additional task-oriented activities based on NDT (TOT-NDT) principle 10 - 36 sessions in 5-8 weeks, 2 to 6 days per sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gross motor task training and Conventional physical therapy (CPT)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group will receive conventional physical therapy and additional gross motor task training 10-36 sessions in 5-8 weeks, 2 to 6 days per sessions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy</intervention_name>
      <description>This will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy.</description>
      <arm_group_label>Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy</arm_group_label>
      <other_name>Comparison between task oriented activities and gross motor task training</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gross motor task training and Conventional physical therapy (CPT)</intervention_name>
      <description>This will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy.</description>
      <arm_group_label>Gross motor task training and Conventional physical therapy (CPT)</arm_group_label>
      <other_name>Comparison between task oriented activities and gross motor task training</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children with spastic cerebral palsy&#xD;
  &#xD;
            -  Both boys and girls&#xD;
  &#xD;
            -  Age 5 - 12 years old&#xD;
  &#xD;
            -  Able to follow verbal commands&#xD;
  &#xD;
            -  Having level I or II of GMFCS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncooperative&#xD;
  &#xD;
            -  On antiepileptic and anti-spastic medications&#xD;
  &#xD;
            -  Having visual or intellectual impairments&#xD;
  &#xD;
            -  Having hearing deficit&#xD;
  &#xD;
            -  With any cardiac anomalies affecting exercise tolerance&#xD;
  &#xD;
            -  Less than 6-month post-orthopedic surgery or post-botulinum toxin injections&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arnab Altaf, Mphill</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Aamna Hassan</name>
        <address>
          <city>Bahawalpur</city>
          <state>Punjab</state>
          <zip>63100</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>January 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Balance</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/NCT05981287
  org study id: REC/RCR & AHS/22/0720
  nct id: NCT05981287
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to find the comparison of task oriented activity based neurodevelopmental
        principles and gross motor task training on balance, trunk control and functional mobility in
        children with cerebral palsy.
  Cerebral palsy (CP) being a non-progressive neurodevelopmental condition, is the leading
        cause of chronic disability in children, making them physically and mentally handicapped and
        socially unapproachable. The low tone of the torso also causes postural instability, lack of
        mobility, and muscle stiffness in the legs. Therapeutic intervention for children with
        cerebral palsy should be composed of goal directed, functional, and meaningful activities by
        considering the clinical type, degree of disability, cognitive level and interest of the
        child. The trunk being the central key point of the body, proximal trunk control is a
        prerequisite for distal limb movement control, balance, and functional mobility. Since
        children with cerebral palsy show damage not only in the function and an ability to
        accomplish tasks, but also in the quality of movement. The objective of this study will be to
        help clinicians regarding the effectiveness of task-oriented training and gross motor
        functional training for children with cerebral palsy.
  
        This will be a Randomized Clinical Trial in which participants of age 5 - 12 years with
        cerebral palsy will be assigned randomly for the study. Population will be taken from
        Physical Therapy Department of Agile Rehabilitation Complex, Bahawalpur. After taking
        consent, demographics including age, gender and birth history etc. will be recorded.
        Questionnaires will be distributed among parents and their responses will be collected.
        Questionnaires for trunk impairment scale, postural assessment scale, pediatric balance scale
        and GMFM-88 will be used as tools of assessment. The collected data will be analyzed in
        Statistical Package for the Social Sciences (SPSS) 27.0.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Pediatric Balance Scale - PBS
  time frame: 2 months
  description: Pediatric balance scale is an outcome measurement tool used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
  measure: Trunk Control Measurement Scale - TCMS
  time frame: 2 months
  description: Trunk Control Measurement Scale is the clinical tool to measure trunk control in children with cerebral palsy. Control of muscles is necessary to maintain stability around the trunk.
  measure: Gross Motor Function Measure 88 - GMFM 88
  time frame: 2 months
  description: The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66). The scoring system of the GMFM is a four-point scale that consists of 66 items divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping.
  arm group label: Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy
  arm group type: Experimental
  description: The experimental group undergo conventional physical therapy and additional task-oriented activities based on NDT (TOT-NDT) principle 10 - 36 sessions in 5-8 weeks, 2 to 6 days per sessions.
  arm group label: Gross motor task training and Conventional physical therapy (CPT)
  arm group type: Active Comparator
  description: This group will receive conventional physical therapy and additional gross motor task training 10-36 sessions in 5-8 weeks, 2 to 6 days per sessions.
  intervention type: Other
  intervention name: Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy
  description: This will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy.
  arm group label: Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy
  other name: Comparison between task oriented activities and gross motor task training
  intervention type: Other
  intervention name: Gross motor task training and Conventional physical therapy (CPT)
  description: This will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy.
  arm group label: Gross motor task training and Conventional physical therapy (CPT)
  other name: Comparison between task oriented activities and gross motor task training
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Arnab Altaf, Mphill
  role: Principal Investigator
  affiliation: Riphah International University
  facility: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Cerebral Palsy
  sharing ipd: No