<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/NCT03256318</url>
  </required_header>
  <id_info>
    <org_study_id>CKNF-1701</org_study_id>
    <nct_id>NCT03256318</nct_id>
  </id_info>
  <brief_title>PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY</brief_title>
  <acronym>PLAY-LONG</acronym>
  <official_title>PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY - Longitudinal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allina Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allina Health System</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>
      Ten year longitudinal survey following children with disabilities who have participated in&#xD;
      Sports and Recreation from a young age (5 to 10), and the parents of children who have&#xD;
      participated in Sports and Recreation at a young age (5 to 10). These children will be&#xD;
      followed for 10 years with surveys every 6 months, whether they are currently participating&#xD;
      in sports and recreation activities or not.&#xD;
&#xD;
      The purpose of this longitudinal study is to examine the effects of early participation in&#xD;
      organized sports and recreation activities (S&amp;R) on self-reported health and health-related&#xD;
      quality of life of children and youth (C&amp;Y) with disabilities and their parent-reported&#xD;
      social participation. This project will examine child and parent reported differences&#xD;
      between:&#xD;
&#xD;
        1. C&amp;Y with disabilities who participate in S&amp;R and those who have discontinued&#xD;
           participation in S&amp;R programs&#xD;
&#xD;
        2. C&amp;Y with disabilities who participate in sports vs. those who participate in recreation,&#xD;
           and&#xD;
&#xD;
        3. C&amp;Y with disabilities who participate in S&amp;R and normative data on C&amp;Y with disabilities&#xD;
           and those without disabilities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">January 21, 2020</completion_date>
  <primary_completion_date type="Actual">January 21, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in health related quality of life</measure>
    <time_frame>Every 6 months for 10 years.</time_frame>
    <description>As measured by KIDSCREEN-10 questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in general health</measure>
    <time_frame>Every 6 months for 10 years.</time_frame>
    <description>Self reported general health as measured by PROMIS Pediatric Global Health Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in social participation</measure>
    <time_frame>Every 6 months for 10 years.</time_frame>
    <description>Self reported (or parent-reported) social participation as measured by PROMIS Pediatric Global Health Measure</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Physical Disability</condition>
  <condition>Quality of Life</condition>
  <condition>Social Interaction</condition>
  <condition>Health, Subjective</condition>
  <arm_group>
    <arm_group_label>Children in Sports and Rec</arm_group_label>
    <description>Children with disabilities who enter the study between ages 5 and 10 who are participating in a Sports and Recreation Program. They will receive no intervention, only surveys.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison Children</arm_group_label>
    <description>Children with disabilities who enter the study between ages 5 and 10 and end participation in Sports and Recreation Program at a later date. They will receive no intervention, only surveys.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention; surveys/questionnaires only</description>
    <arm_group_label>Children in Sports and Rec</arm_group_label>
    <arm_group_label>Comparison Children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants for this research study will be recruited from five- to ten- year old children&#xD;
        and their parents who are participating in adapted sports and recreation programs. These&#xD;
        children will have a variety of physical disabilities, and be participating in a wide range&#xD;
        of sports and recreation programs, including basketball, skiing, baseball, archery,&#xD;
        bowling, curling, cycling, golf, horseback riding, martial arts, Nordic skiing, soccer,&#xD;
        rock climbing, scuba, swimming, water skiing, rugby, softball tennis, and track and field.&#xD;
        The types of sport and recreation activities changes from year to year, as activities&#xD;
        become more or less popular.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At the time of enrollment, the child must be between the ages of 5 and 10 and be&#xD;
             participating in an adapted sports and recreation program.&#xD;
&#xD;
          -  At the time of enrollment, the parent must have a child between the ages of 5 and 10,&#xD;
             who is participating in an adapted sports and recreation program.&#xD;
&#xD;
          -  Children and parents who are enrolled in the study will continue to participate in the&#xD;
             study for 10 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who are younger than 5 or older than 10 will not be entered into the study,&#xD;
             nor will parents whose children are younger than 5 or older than 10 be entered into&#xD;
             the study. .&#xD;
&#xD;
          -  Individuals who do not read and write in English will be excluded from the study.&#xD;
&#xD;
          -  Children who are wards of the state, or in foster care will be excluded from the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Flinn, PhD, OTR/L</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allina Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Courage Kenny Rehabilitation Institute</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Allina Health System</investigator_affiliation>
    <investigator_full_name>Nancy Flinn</investigator_full_name>
    <investigator_title>Senior Scientific Advisor</investigator_title>
  </responsible_party>
  <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/NCT03256318
org study id: CKNF-1701
nct id: NCT03256318
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ten year longitudinal survey following children with disabilities who have participated in
      Sports and Recreation from a young age (5 to 10), and the parents of children who have
      participated in Sports and Recreation at a young age (5 to 10). These children will be
      followed for 10 years with surveys every 6 months, whether they are currently participating
      in sports and recreation activities or not.

      The purpose of this longitudinal study is to examine the effects of early participation in
      organized sports and recreation activities (S&R) on self-reported health and health-related
      quality of life of children and youth (C&Y) with disabilities and their parent-reported
      social participation. This project will examine child and parent reported differences
      between:

        1. C&Y with disabilities who participate in S&R and those who have discontinued
           participation in S&R programs

        2. C&Y with disabilities who participate in sports vs. those who participate in recreation,
           and

        3. C&Y with disabilities who participate in S&R and normative data on C&Y with disabilities
           and those without disabilities.
observational model: Case-Control
time perspective: Prospective
measure: Change in health related quality of life
time frame: Every 6 months for 10 years.
description: As measured by KIDSCREEN-10 questionnaire
measure: Change in general health
time frame: Every 6 months for 10 years.
description: Self reported general health as measured by PROMIS Pediatric Global Health Measure
measure: Change in social participation
time frame: Every 6 months for 10 years.
description: Self reported (or parent-reported) social participation as measured by PROMIS Pediatric Global Health Measure
arm group label: Children in Sports and Rec
description: Children with disabilities who enter the study between ages 5 and 10 who are participating in a Sports and Recreation Program. They will receive no intervention, only surveys.
arm group label: Comparison Children
description: Children with disabilities who enter the study between ages 5 and 10 and end participation in Sports and Recreation Program at a later date. They will receive no intervention, only surveys.
intervention type: Other
intervention name: No intervention
description: No intervention; surveys/questionnaires only
arm group label: Children in Sports and Rec
arm group label: Comparison Children
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 10 Years
healthy volunteers: No
last name: Nancy Flinn, PhD, OTR/L
role: Principal Investigator
affiliation: Allina Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Allina Health System
investigator full name: Nancy Flinn
investigator title: Senior Scientific Advisor
sharing ipd: No