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/NCT05978778</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR&amp;AHS/23/0722</org_study_id>
      <nct_id>NCT05978778</nct_id>
    </id_info>
    <brief_title>Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.</brief_title>
    <official_title>Effects of Active Video Gaming on Pre-handwriting Skills of Children With Down Syndrome.</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>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>
        Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is most common&#xD;
        genetic mental disability that affects children physically, mentally and functionally. It&#xD;
        occurs due to an extra copy of chromosome 21. It involves a slightly flattened facial&#xD;
        profile, low muscle tone upward-slanted eyes, and ligamentous laxity. Central hypotonia,&#xD;
        mental retardation and short stature are very common features of children with down's&#xD;
        syndrome. Children with down's syndrome are characterized by awkward movements, gait,&#xD;
        increased flexibility of joints, timing of mastering of basic skills and , under-development&#xD;
        of fine motor skills. Active video gaming used different games that involve interactive&#xD;
        session that can enhance cortical recognition, motor learning and functional profile of&#xD;
        children with DS. The objective of this study is to determine the effects of active video&#xD;
        gaming on pre-hand writing skills of children with down's syndrome. This will be a&#xD;
        RCT(Randomized Controlled Trial).The sample size was 18 and the study design was a&#xD;
        case-control trial. The inclusion criteria are children with down syndrome age 6 to 12 years&#xD;
        both male and female patients are randomly selected and children with poor pre-hand writing&#xD;
        skills. And the exclusion criteria for this study is children with any other neurological&#xD;
        condition like (epilepsy, instability of atlantoaxial joints, cardiac anomalies,) vision, and&#xD;
        hearing loss. Two groups were randomly assigned and equally divided patients into each group.&#xD;
        Group A received pre-handwriting skills, like tracing alphabets and numbers, scribbling,&#xD;
        coloring, painting, and group B received active video gaming and prehandwriting skills. For&#xD;
        measuring each group developmental coordination&#xD;
  &#xD;
        disorder questionnaire tool is used. The session will be taken 30 mins thrice a week for&#xD;
        (8consecutive weeks). Data collected from different centers, Raising sun institute of special&#xD;
        education. Autism resource center Lahore. SPSS for Windows software, version 25 will be used&#xD;
        to analyze the data using statistical Significance p=0.05. The Shapiro-Wilk test will be used&#xD;
        to check the normality of data. Keywords: Active video gaming, Down syndrome, Computer game,&#xD;
        Fine motor skills, Pre-hand writing skills, Virtual reality gaming.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To determine the effects of active video gaming on pre-hand writing skills of children with&#xD;
        down syndrome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 27, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 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>
      <intervention_model_description>Effects of active video gaming on pre-handwriting skills of children with down's&#xD;
  syndrome.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Effects of active video gaming on pre-handwriting skills of children with down's&#xD;
  syndrome.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>pre handwriting skills syndrome.</measure>
      <time_frame>6 months</time_frame>
      <description>bilateral hand use will determine by box and ball test children with down syndrome.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Down Syndrome</condition>
    <arm_group>
      <arm_group_label>controlled group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Nine children will be randomly allocated to control group who receive only pre-hand writing skills.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Nine children will be randomly allocated to experimental group who receive active video gaming along with pre-hand writing skills.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>wii sports game</intervention_name>
      <description>wii sports is a collection five sports game stimulation,which have been designed to demonstrate the motion sensing capabilities of wii remote</description>
      <arm_group_label>Experimental group</arm_group_label>
      <other_name>video gaming</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>pre-hand writing skills</intervention_name>
      <description>pre-hand writing skills</description>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_label>controlled group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 5 to 14 years.&#xD;
  &#xD;
            -  Both male and female patient diagnosed with down syndrome.&#xD;
  &#xD;
            -  Able to understand and follow verbal command.&#xD;
  &#xD;
            -  Down syndrome children with pre-hand writing skills are not good.&#xD;
  &#xD;
            -  Difficulty in fine motor skills.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients will have any neurological sign (epilepsy, instability of the atlantoaxial&#xD;
               joint, cardiac anomalies, vision and hearing loss, speech loss.&#xD;
  &#xD;
            -  Musculoskeletal and mobility disorder.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nageen Zahra, ms</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ripha International Univerity</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Imran Amjad, PhD</last_name>
      <phone>03324390125</phone>
      <email>imran.amjad@riphah.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Muhammad Asif Javed, ms</last_name>
      <phone>03224209422</phone>
      <email>a.javed@riphah.edu.pk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Lingua Speech Model town</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>O'BRIEN JC, O'BRIEN MO. Educational Systems. Pediatric Skills for Occupational Therapy Assistants E-Book. 2020 Jul 12:46.</citation>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Down Syndrome</mesh_term>
      <mesh_term>Syndrome</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/NCT05978778
  org study id: REC/RCR&AHS/23/0722
  nct id: NCT05978778
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Down's syndrome is a genetic disorder caused by trisomy 21. Down's syndrome is most common
        genetic mental disability that affects children physically, mentally and functionally. It
        occurs due to an extra copy of chromosome 21. It involves a slightly flattened facial
        profile, low muscle tone upward-slanted eyes, and ligamentous laxity. Central hypotonia,
        mental retardation and short stature are very common features of children with down's
        syndrome. Children with down's syndrome are characterized by awkward movements, gait,
        increased flexibility of joints, timing of mastering of basic skills and , under-development
        of fine motor skills. Active video gaming used different games that involve interactive
        session that can enhance cortical recognition, motor learning and functional profile of
        children with DS. The objective of this study is to determine the effects of active video
        gaming on pre-hand writing skills of children with down's syndrome. This will be a
        RCT(Randomized Controlled Trial).The sample size was 18 and the study design was a
        case-control trial. The inclusion criteria are children with down syndrome age 6 to 12 years
        both male and female patients are randomly selected and children with poor pre-hand writing
        skills. And the exclusion criteria for this study is children with any other neurological
        condition like (epilepsy, instability of atlantoaxial joints, cardiac anomalies,) vision, and
        hearing loss. Two groups were randomly assigned and equally divided patients into each group.
        Group A received pre-handwriting skills, like tracing alphabets and numbers, scribbling,
        coloring, painting, and group B received active video gaming and prehandwriting skills. For
        measuring each group developmental coordination
  
        disorder questionnaire tool is used. The session will be taken 30 mins thrice a week for
        (8consecutive weeks). Data collected from different centers, Raising sun institute of special
        education. Autism resource center Lahore. SPSS for Windows software, version 25 will be used
        to analyze the data using statistical Significance p=0.05. The Shapiro-Wilk test will be used
        to check the normality of data. Keywords: Active video gaming, Down syndrome, Computer game,
        Fine motor skills, Pre-hand writing skills, Virtual reality gaming.
  To determine the effects of active video gaming on pre-hand writing skills of children with
        down syndrome.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Effects of active video gaming on pre-handwriting skills of children with down's
  syndrome.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Effects of active video gaming on pre-handwriting skills of children with down's
  syndrome.
  measure: pre handwriting skills syndrome.
  time frame: 6 months
  description: bilateral hand use will determine by box and ball test children with down syndrome.
  arm group label: controlled group
  arm group type: Other
  description: Nine children will be randomly allocated to control group who receive only pre-hand writing skills.
  arm group label: Experimental group
  arm group type: Experimental
  description: Nine children will be randomly allocated to experimental group who receive active video gaming along with pre-hand writing skills.
  intervention type: Device
  intervention name: wii sports game
  description: wii sports is a collection five sports game stimulation,which have been designed to demonstrate the motion sensing capabilities of wii remote
  arm group label: Experimental group
  other name: video gaming
  intervention type: Other
  intervention name: pre-hand writing skills
  description: pre-hand writing skills
  arm group label: Experimental group
  arm group label: controlled group
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 14 Years
  healthy volunteers: No
  last name: Nageen Zahra, ms
  role: Principal Investigator
  affiliation: Ripha International Univerity
  last name: Imran Amjad, PhD
  phone: 03324390125
  email: imran.amjad@riphah.edu.pk
  last name: Muhammad Asif Javed, ms
  phone: 03224209422
  email: a.javed@riphah.edu.pk
  facility: 
  status: Recruiting
  country: Pakistan
  citation: O'BRIEN JC, O'BRIEN MO. Educational Systems. Pediatric Skills for Occupational Therapy Assistants E-Book. 2020 Jul 12:46.
  responsible party type: Sponsor
  mesh term: Down Syndrome
  mesh term: Syndrome
  sharing ipd: No