Cerebral PalsyNCT02110290
Effects of an Adapted Ski/Snowboarding Program on Quality of Life in Children With Physical Disabilities
An observational study of Cerebral Palsy and Traumatic Brain Injuries, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy, Traumatic Brain Injuries, Spinal Cord Injuries
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Physical disability
- Participant of HSP program
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Keywords
- quality of life, adaptive sports, therapeutic recreation, mental health
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Traumatic, Spinal Cord Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
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.
Measured: Up to 5 years after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startOct 2010
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Chang, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110290
- Sponsor's protocol ID
- 10-1111
- Status last verified
- Oct 2019
- First submitted
- 7 Apr 2014
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adapted Skiing and Snowboarding on Quality of Life in Children With Physical Disabilities
- ClinicalTrials.gov ID
- NCT02110290
- Acronym / sponsor ID
- 10-1111
- Keywords
- quality of life, adaptive sports, therapeutic recreation, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Physical disability
- Participant of HSP program
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Chang, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Traumatic Brain Injuries, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Wellbeing (time frame: Up to 5 years after study enrollment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.