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/NCT05986760</url>
    </required_header>
    <id_info>
      <org_study_id>RiphahIU-ASAD</org_study_id>
      <nct_id>NCT05986760</nct_id>
    </id_info>
    <brief_title>Comparsion of SPARK and Fundamental Motor Training</brief_title>
    <official_title>Effects of Sports, Play and Active Recreation for Kids (SPARK) Versus Fundamental Motor Skill Training on Social and Motor Skills in Children With Autism Spectrum Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>khadija liaquat</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>
        It was a Randomized Clinical Trial.Data will be collected from Life care rehabilitation and&#xD;
        special child facility.The study was completed within 6 months after approval of synopsis.The&#xD;
  &#xD;
        calculated sample size, through WHO sample size calculator, using Bruininks- Oseretsky test's&#xD;
        mean and standard deviation (Mean Dynamic Balance) as outcome&#xD;
  &#xD;
        measure was 20 in each group. After adding 10% dropout the sample size will be 20+4=24 in&#xD;
        each group; hence, overall sample size n= 20. Age range 5-12 years. Children with diagnosed&#xD;
        Autism and age ranges between 5-12 will be included in the study.Convenient Sampling&#xD;
        Technique was used to collect the data.There was two groups.In Group A SPARK therapy will be&#xD;
        provided and in group 2 fundamental motor skill training will be provided. To assess the&#xD;
        social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) and for motor skills&#xD;
        Bruininkse Oseretsky test of motor proficiency (BOTMP) was used.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Autism Spectrum Disorder affects the social communication and fundamental motor skills of&#xD;
        children. The current study will evaluate the effects of sports play and active recreation&#xD;
        for kids (SPARK) versus fundamental motor skill training on social and motor skills in&#xD;
        children with Autism spectrum disorder. It was a Randomized Clinical Trial.Data will be&#xD;
        collected from Life care rehabilitation and special child facility.The study was completed&#xD;
        within 6 months after approval of synopsis.The&#xD;
  &#xD;
        calculated sample size, through WHO sample size calculator, using Bruininks- Oseretsky test's&#xD;
        mean and standard deviation (Mean Dynamic Balance) as outcome&#xD;
  &#xD;
        measure was 20 in each group. After adding 10% dropout the sample size will be 20+4=24 in&#xD;
        each group; hence, overall sample size n= 20. Age range 5-12 years. Children with diagnosed&#xD;
        Autism and age ranges between 5-12 will be included in the study.Convenient Sampling&#xD;
        Technique was used to collect the data.There was two groups.In Group A SPARK therapy will be&#xD;
        provided and in group 2 fundamental motor skill training will be provided. To assess the&#xD;
        social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) and for motor skills&#xD;
        Bruininkse Oseretsky test of motor proficiency (BOTMP) was used. Analysis was carried out on&#xD;
        SPSS version 27.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 27, 2022</start_date>
    <completion_date type="Actual">May 27, 2023</completion_date>
    <primary_completion_date type="Actual">May 27, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The SPARK is an evidence based plan designed to improve health-related well-being and to maintain the positive socialization and enjoyment of physical activities or academic achievements.(4) The SPARK discipline is in line with NASPE (National Association of Sport and PE) guidelines. A standard SPARK lesson will be delivered in two parts: a health fitness activity and a skill-fitness activity. In the health fitness activity part, there will be 13 activities that include aerobic dance, running games and jump ropes. In this part, the main focus will be on developing cardiovascular endurance and promotion by modifying the intensity, duration and complexity of the activities.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Social skills</measure>
      <time_frame>Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention</time_frame>
      <description>Gilliam Autism Rating Scale-Second Edition (GARS-2)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Motor Skills:</measure>
      <time_frame>Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention</time_frame>
      <description>Bruininkse Oseretsky test of motor proficiency (BOTMP)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">18</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>SPARK</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The SPARK is an evidence based plan designed to improve health-related well-being and to maintain the positive socialization and enjoyment of physical activities or academic achievements.(4) The SPARK discipline is in line with NASPE (National Association of Sport and PE) guidelines. A standard SPARK lesson will be delivered in two parts: a health fitness activity and a skill-fitness activity. In the health fitness activity part, there will be 13 activities that include aerobic dance, running games and jump ropes. In this part, the main focus will be on developing cardiovascular endurance and promotion by modifying the intensity, duration and complexity of the activities. The activities will be mostly aimed to develop abdominal and upper body strength.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fundamental Motor training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In terms of motor development, fundamental motor skills (FMS, e.g., locomotor and object manipulation)-such as running, jumping, throwing, and kicking-are considered the essential building blocks for further, more complex gross motor movement. (24) There will be 13 FMS activities including; running, jumping, Gallop, hopping, side gliding, skipping, leaping, catching, stationary dribbles, kicking, striking a stationary ball, overarm throw and underarm throw. FMS group will receive 30 sessions for 10 weeks (3 sessions per week, 60 min per session including CPT).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SPARK</intervention_name>
      <description>Functional Motor training</description>
      <arm_group_label>Fundamental Motor training</arm_group_label>
      <arm_group_label>SPARK</arm_group_label>
      <other_name>FMS</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age range 5-9 years (11) • Diagnosed with an Autism Spectrum Disorder (ASD) based on&#xD;
               Diagnostic and&#xD;
  &#xD;
          Statistical Manual of Mental Disorders,&#xD;
  &#xD;
            -  Pervasive developmental disorder-not otherwise specified&#xD;
  &#xD;
            -  Asperger's disorder based on clinical judgment and supported by the Autism Diagnostic&#xD;
               Observation Schedule&#xD;
  &#xD;
            -  Having moderate or greater behavioral problems as measured by a pretreatment score of&#xD;
               &gt;15 on the Aberrant Behavior Checklist-Irritability subscale&#xD;
  &#xD;
            -  Ability to follow directions and perform requested motor skill proficiency and&#xD;
               executive function measures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with diagnosed cognitive impairments&#xD;
  &#xD;
                 -  Unable to walk independently&#xD;
  &#xD;
                 -  History of traumatic injury&#xD;
  &#xD;
                 -  History of previous surgery history&#xD;
  &#xD;
                 -  Inability to understand the procedure and unwillingness to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>9 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Riphah Rehabilitation Center</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Riphah International University</investigator_affiliation>
      <investigator_full_name>khadija liaquat</investigator_full_name>
      <investigator_title>Senior lecturer</investigator_title>
    </responsible_party>
    <keyword>Autism Spectrum Disorder</keyword>
    <keyword>Motor Skill</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</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/NCT05986760
  org study id: RiphahIU-ASAD
  nct id: NCT05986760
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  It was a Randomized Clinical Trial.Data will be collected from Life care rehabilitation and
        special child facility.The study was completed within 6 months after approval of synopsis.The
  
        calculated sample size, through WHO sample size calculator, using Bruininks- Oseretsky test's
        mean and standard deviation (Mean Dynamic Balance) as outcome
  
        measure was 20 in each group. After adding 10% dropout the sample size will be 20+4=24 in
        each group; hence, overall sample size n= 20. Age range 5-12 years. Children with diagnosed
        Autism and age ranges between 5-12 will be included in the study.Convenient Sampling
        Technique was used to collect the data.There was two groups.In Group A SPARK therapy will be
        provided and in group 2 fundamental motor skill training will be provided. To assess the
        social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) and for motor skills
        Bruininkse Oseretsky test of motor proficiency (BOTMP) was used.
  Autism Spectrum Disorder affects the social communication and fundamental motor skills of
        children. The current study will evaluate the effects of sports play and active recreation
        for kids (SPARK) versus fundamental motor skill training on social and motor skills in
        children with Autism spectrum disorder. It was a Randomized Clinical Trial.Data will be
        collected from Life care rehabilitation and special child facility.The study was completed
        within 6 months after approval of synopsis.The
  
        calculated sample size, through WHO sample size calculator, using Bruininks- Oseretsky test's
        mean and standard deviation (Mean Dynamic Balance) as outcome
  
        measure was 20 in each group. After adding 10% dropout the sample size will be 20+4=24 in
        each group; hence, overall sample size n= 20. Age range 5-12 years. Children with diagnosed
        Autism and age ranges between 5-12 will be included in the study.Convenient Sampling
        Technique was used to collect the data.There was two groups.In Group A SPARK therapy will be
        provided and in group 2 fundamental motor skill training will be provided. To assess the
        social skills Gilliam Autism Rating Scale-Second Edition (GARS-2) and for motor skills
        Bruininkse Oseretsky test of motor proficiency (BOTMP) was used. Analysis was carried out on
        SPSS version 27.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The SPARK is an evidence based plan designed to improve health-related well-being and to maintain the positive socialization and enjoyment of physical activities or academic achievements.(4) The SPARK discipline is in line with NASPE (National Association of Sport and PE) guidelines. A standard SPARK lesson will be delivered in two parts: a health fitness activity and a skill-fitness activity. In the health fitness activity part, there will be 13 activities that include aerobic dance, running games and jump ropes. In this part, the main focus will be on developing cardiovascular endurance and promotion by modifying the intensity, duration and complexity of the activities.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Social skills
  time frame: Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
  description: Gilliam Autism Rating Scale-Second Edition (GARS-2)
  measure: Motor Skills:
  time frame: Assessment took at 0 week of intervention and final reading was taken on 10th week of intervention
  description: Bruininkse Oseretsky test of motor proficiency (BOTMP)
  arm group label: SPARK
  arm group type: Experimental
  description: The SPARK is an evidence based plan designed to improve health-related well-being and to maintain the positive socialization and enjoyment of physical activities or academic achievements.(4) The SPARK discipline is in line with NASPE (National Association of Sport and PE) guidelines. A standard SPARK lesson will be delivered in two parts: a health fitness activity and a skill-fitness activity. In the health fitness activity part, there will be 13 activities that include aerobic dance, running games and jump ropes. In this part, the main focus will be on developing cardiovascular endurance and promotion by modifying the intensity, duration and complexity of the activities. The activities will be mostly aimed to develop abdominal and upper body strength.
  arm group label: Fundamental Motor training
  arm group type: Experimental
  description: In terms of motor development, fundamental motor skills (FMS, e.g., locomotor and object manipulation)-such as running, jumping, throwing, and kicking-are considered the essential building blocks for further, more complex gross motor movement. (24) There will be 13 FMS activities including; running, jumping, Gallop, hopping, side gliding, skipping, leaping, catching, stationary dribbles, kicking, striking a stationary ball, overarm throw and underarm throw. FMS group will receive 30 sessions for 10 weeks (3 sessions per week, 60 min per session including CPT).
  intervention type: Behavioral
  intervention name: SPARK
  description: Functional Motor training
  arm group label: Fundamental Motor training
  arm group label: SPARK
  other name: FMS
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 9 Years
  healthy volunteers: No
  facility: 
  country: Pakistan
  responsible party type: Sponsor-Investigator
  investigator affiliation: Riphah International University
  investigator full name: khadija liaquat
  investigator title: Senior lecturer
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: No