Down Syndrome Clinical Trial
Official title:
The Effect of Balance Bike Training on Balance, Physical Activity Levels, and Participation in Children and Youth Down Down Syndrome: a Pilot Study
Verified date | April 2020 |
Source | University of Mississippi Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Children with Down syndrome (DS) present with hypotonia, impaired balance and poor gross motor proficiency which lead to difficulty learning new motor skills, decreased engagement in physical activity, and limited participation in home, school, and community activities. Bicycle riding is a popular childhood activity with multiple health benefits; however, children with DS often have difficulty learning to ride a standard two-wheel bike. Purpose: The purpose of this pilot study is to determine the effectiveness of the Strider "Learn to Ride" intervention when used to teach children with DS to ride a two-wheel balance bike. Additional purposes include examining the immediate effects of the five-day "Learn to Ride" intervention on the balance of children with DS and the long-term effects of completion of the intervention on the participation and physical activity levels of children with DS. Methods: An estimated 10 children between the ages of 5 and 17 years old will be recruited to participate in this pre- post-test group design study. The participants will complete the five-day Strider "Learn to Ride" intervention under the instruction of a pediatric physical therapist. The immediate effects of the intervention on distance cycled and balance, using the Pediatric Balance Scale (PBS), will be assessed. Participation and physical activity levels will be assessed at long term follow-up using the Participation and Environment Measure for Children and Youth (PEM-CY) and a PROMIS physical activity questionnaire.
Status | Completed |
Enrollment | 8 |
Est. completion date | June 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility |
Inclusion Criteria: - be between the ages of 5 and 17 years old with a diagnosis of Down syndrome - have the core strength and balance necessary to maintain sitting on a two-wheel balance bike with their feet on the ground - be able to follow simple commands. Exclusion Criteria: - significant cardiovascular event or illness in the past 6 months - another medical diagnosis, besides Down syndrome, that would limit participation in the exercise programs. |
Country | Name | City | State |
---|---|---|---|
United States | University of Mississippi Wellness Center | Flowood | Mississippi |
Lead Sponsor | Collaborator |
---|---|
University of Mississippi Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pediatric Balance Scale (PBS) Mean Group Score | The Pediatric Balance Scale (PBS) is a valid, 14-item assessment, developed based on the Berg Balance Scale, to assess balance in children. The PBS is a criterion-based measure, with each item scored on a 0-4 scale. The minimum score possible on the PBS is 0 points. The highest total score possible on the PBS is 56 points. Higher scores indicates better balance performance.The score reported is the mean PBS score of the group on day 5, the last day of the intervention. | Day 1 and Day 5 | |
Primary | Distance Biked | How far, up to 100', that the child can independently ride their Strider bike | Day 1 and day 5 | |
Primary | Change in Participation Level Based on the Participation and Environment Measure - Children and Youth (PEM-CY) | The PEM-CY is participation level outcome measure used to assess a child's engagement in activities in the home, school, and community environments. The PEM-CY is a valid and reliable measure and is completed by parent/caregiver report, making it appropriate to use with children with DS. The PEM-CY asks questions related to 25 types of activiites that take place in the home, school, and community environments. Parents report "how often" their child has participated in each activity over the last 4 months (daily; few times a week; once a week; few times a month; once a month; few times in the last four months; once in the last four months; never); "how involved" their child is when participating in 1 or 2 activities that she or he does most often (5-very involved, 4, 3-somewhat involved, 2, 1-minimally involved); whether or not they want their child's participation to change and how they want it to change. The PEM-CY does not have scale scores or a total score. | 3 months, 6 months | |
Primary | Change in Physical Activity Based on the Patient Reported Outcome Measure Information System (PROMIS) Physical Activity Measure - Proxy Report | PROMIS Physical Activity outcome measures assesses various aspects related to a child's participation in physical activity.The PROMIS measure has 10 items that parents rate on a 5-point likert scale. A 1 indicates that the child participated in the activity "no days", 2 indicates that the child participated in the activity 1 day, 3 indicates that the child participated in the activity 2-3 days, 4 indicates that the child participated in the activity 4-5 days, and 5 indicates that the child participated in the activity 6-7 days. The PROMIS does not contain a total score. | 3 months, 6 months |
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