NCT03256318

Brief 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. 1.C\&Y with disabilities who participate in S\&R and those who have discontinued participation in S\&R programs
  2. 2.C\&Y with disabilities who participate in sports vs. those who participate in recreation, and
  3. 3.C\&Y with disabilities who participate in S\&R and normative data on C\&Y with disabilities and those without disabilities.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

2.4 years

First QC Date

August 18, 2017

Last Update Submit

February 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in health related quality of life

    As measured by KIDSCREEN-10 questionnaire

    Every 6 months for 10 years.

Secondary Outcomes (2)

  • Change in general health

    Every 6 months for 10 years.

  • Change in social participation

    Every 6 months for 10 years.

Study Arms (2)

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.

Other: No intervention

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.

Other: No intervention

Interventions

No intervention; surveys/questionnaires only

Children in Sports and RecComparison Children

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participants for this research study will be recruited from five- to ten- year old children and their parents who are participating in adapted sports and recreation programs. These children will have a variety of physical disabilities, and be participating in a wide range of sports and recreation programs, including basketball, skiing, baseball, archery, bowling, curling, cycling, golf, horseback riding, martial arts, Nordic skiing, soccer, rock climbing, scuba, swimming, water skiing, rugby, softball tennis, and track and field. The types of sport and recreation activities changes from year to year, as activities become more or less popular.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Courage Kenny Rehabilitation Institute

Golden Valley, Minnesota, 55422, United States

Location

Study Officials

  • Nancy Flinn, PhD, OTR/L

    Allina Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientific Advisor

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 22, 2017

Study Start

August 30, 2017

Primary Completion

January 21, 2020

Study Completion

January 21, 2020

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations