N/A
N=8
Balance Bike Training in Down Syndrome
Down Syndrome · Postural Balance
Bottom Line
View on ClinicalTrials.gov: NCT03677245 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Pediatric Balance Scale (PBS) Mean Group Score — 48.43; 49.43 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Strider Balance Bike (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- University of Mississippi Medical Center
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Balance Scale (PBS) Mean Group Score |
48.43; 49.43 | <0.05 sig |
| PRIMARY Distance Biked |
84; 100 | — |
| PRIMARY Change in Participation Level Based on the Participation and Environment Measure - Children and Youth (PEM-CY) |
— | — |
| PRIMARY Change in Physical Activity Based on the Patient Reported Outcome Measure Information System (PROMIS) Physical Activity Measure - Proxy Report |
— | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03677245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.