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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03256318
Other study ID # CKNF-1701
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 30, 2017
Est. completion date January 21, 2020

Study information

Verified date February 2020
Source Allina Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date January 21, 2020
Est. primary completion date January 21, 2020
Accepts healthy volunteers No
Gender All
Age group 5 Years to 10 Years
Eligibility 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 Design


Intervention

Other:
No intervention
No intervention; surveys/questionnaires only

Locations

Country Name City State
United States Courage Kenny Rehabilitation Institute Golden Valley Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in health related quality of life As measured by KIDSCREEN-10 questionnaire Every 6 months for 10 years.
Secondary Change in general health Self reported general health as measured by PROMIS Pediatric Global Health Measure Every 6 months for 10 years.
Secondary Change in social participation Self reported (or parent-reported) social participation as measured by PROMIS Pediatric Global Health Measure Every 6 months for 10 years.
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