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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02110290
Other study ID # 10-1111
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2010
Est. completion date August 2016

Study information

Verified date October 2019
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is assessing quality of life in children with a physical disability who participate in the Children's Hospital Colorado Hospital Sports Program (HSP), where children with physical disabilities are able to participate in more organized sports and active programs with the use of adaptive equipment. This study would assess a child's self reported and parent perceived quality of life before and after child participation in HSP for the winter season. The investigators aim to determine the level of child and parent happiness and satisfaction in specific quality of life aspects including: physical activities and health, feelings, moods, self perception, home life, friends, school, learning and bullying. The investigators believe that children with any physical disability will have a more satisfactory reported quality of life after participating in HSP for one or many years.


Description:

The purpose of this proposed research is to quantify the impact of participation in an adaptive ski/snowboarding program on parent perceived and child self-reported health related quality of life. To this effect, the study will assess children's self-perception of psychological, emotional, physical health of participants as well as their parents perception of the same, through the use of a validated self reported quality of life questionnaire, KIDSCREEN-52, before and after participating in an adaptive ski/snowboarding program every year.

Primary Aims:

1. To determine the level of subject and parent satisfaction and happiness, through a composite of 10 aspects in a quality of life questionnaire, following participation in the Children's Hospital Colorado Hospital Sports Program (HSP) for one winter season.

2. To determine the long-term impact of repeated participation in an adapted ski/snowboarding program through a composite of 10 aspects in a quality of life questionnaire, following participation in the Children's Hospital Colorado Hospital Sports Program (HSP) for consistent winter seasons.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria:

- Physical disability

- Participant of HSP program

Exclusion Criteria:

- Completed parent and child KIDSCREEN questionnaires are not received before the subject's first day of skiing or snowboarding with the program

- Completed parent and child KIDSCREEN questionnaires are not received within 3 months after subject's completed participation with the program for that winter season

Study Design


Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Wellbeing Short-term and long-term changes in the physical wellbeing assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary Psychological Wellbeing Short-term and long-term changes in the psychological wellbeing assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary Moods and Emotions Short-term and long-term changes in the moods and emotions assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary Self Perception Short-term and long-term changes in the self perception assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary Autonomy Short-term and long-term changes in the autonomy assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary Parents Short-term and long-term changes in the feelings towards parents assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary Financial Short-term and long-term changes in the feelings towards finance assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary Peers Short-term and long-term changes in the feelings towards peers assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary School Short-term and long-term changes in the feelings toward school assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
Primary Bullying Short-term and long-term changes in the feelings toward bullying assessed by both the child and parent in the questionnaire will be compared. The pre-season and post-season questionnaires from the same ski season will be used to compare changes after participation in one season. The earliest pre-season questionnaire and most recent post-season questionnaire will be compared to evaluate long-term changes. Up to 5 years after study enrollment
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