Effects of an Adapted Ski/Snowboarding Program on Quality of Life in Children With Physical Disabilities

October 29, 2019 updated by: University of Colorado, Denver

Effects of Adapted Skiing and Snowboarding on Quality of Life in Children With Physical Disabilities

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The Hospital Sports Program at Children's Hospital Colorado only has the capability to accommodate 60 to 65 children a year. This study contacts all of the subjects who meet the study inclusion criteria from the enrolled HSP participant list. It should be noted that the investigators will only be recruiting from children already participating in HSP; they will not be recruiting for children to join HSP.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Children with Physical Disabilities
This group includes children 8-18 years old participating in an adapted ski/snowboarding program with any type of physical disability, including cerebral palsy, traumatic brain injury, spinal cord injury, and amputation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Wellbeing
Time Frame: Up to 5 years after study enrollment
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
Psychological Wellbeing
Time Frame: Up to 5 years after study enrollment
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
Moods and Emotions
Time Frame: Up to 5 years after study enrollment
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
Self Perception
Time Frame: Up to 5 years after study enrollment
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
Autonomy
Time Frame: Up to 5 years after study enrollment
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
Parents
Time Frame: Up to 5 years after study enrollment
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
Financial
Time Frame: Up to 5 years after study enrollment
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
Peers
Time Frame: Up to 5 years after study enrollment
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
School
Time Frame: Up to 5 years after study enrollment
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
Bullying
Time Frame: Up to 5 years after study enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frank Chang, MD, Children's Hospital Colorado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-1111

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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