- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03256318
PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY (PLAY-LONG)
PLAY LONG: The Effect of Sports and Recreation Participation for Young chiLdren With physicAl disabilitY - Longitudinal Study
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:
- C&Y with disabilities who participate in S&R and those who have discontinued participation in S&R programs
- C&Y with disabilities who participate in sports vs. those who participate in recreation, and
- C&Y with disabilities who participate in S&R and normative data on C&Y with disabilities and those without disabilities.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Golden Valley, Minnesota, United States, 55422
- Courage Kenny Rehabilitation Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- At the time of enrollment, the child must be between the ages of 5 and 10 and be participating in an adapted sports and recreation program.
- At the time of enrollment, the parent must have a child between the ages of 5 and 10, who is participating in an adapted sports and recreation program.
- Children and parents who are enrolled in the study will continue to participate in the study for 10 years.
Exclusion Criteria:
- Children who are younger than 5 or older than 10 will not be entered into the study, nor will parents whose children are younger than 5 or older than 10 be entered into the study. .
- Individuals who do not read and write in English will be excluded from the study.
- Children who are wards of the state, or in foster care will be excluded from the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children in Sports and Rec
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.
|
No intervention; surveys/questionnaires only
|
Comparison Children
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.
|
No intervention; surveys/questionnaires only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in health related quality of life
Time Frame: Every 6 months for 10 years.
|
As measured by KIDSCREEN-10 questionnaire
|
Every 6 months for 10 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in general health
Time Frame: Every 6 months for 10 years.
|
Self reported general health as measured by PROMIS Pediatric Global Health Measure
|
Every 6 months for 10 years.
|
Change in social participation
Time Frame: Every 6 months for 10 years.
|
Self reported (or parent-reported) social participation as measured by PROMIS Pediatric Global Health Measure
|
Every 6 months for 10 years.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nancy Flinn, PhD, OTR/L, Allina Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CKNF-1701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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