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NCT03677245 · ClinicalTrials.gov registry record · NA
Balance Bike Training in Down Syndrome
A NA study of Down Syndrome and Postural Balance, sponsored by University of Mississippi Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03677245 is a NA study of Down Syndrome and Postural Balance that has completed, run by University of Mississippi Medical Center. The registered enrollment target is 8 participants, below the 2,472-participant average among 54 other Down Syndrome trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03677245, a NA study of Down Syndrome and Postural Balance, has completed, sponsored by University of Mississippi Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Strider Balance Bike
Study Locations (1)
Mississippi
- University of Mississippi Wellness Center - Flowood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2019-06-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03677245
The ClinicalTrials.gov registry entry for NCT03677245 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,472-participant average among 54 other Down Syndrome trials with a reported enrollment target (100% lower). The listed sponsor is University of Mississippi Medical Center, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Strider Balance Bike is the first listed.
NCT03677245 reports 1 study location spanning 1 distinct geographic area - top geographies include Mississippi.
Frequently Asked Questions
What is clinical trial NCT03677245 about?
NCT03677245 is a clinical study titled "Balance Bike Training in Down Syndrome". 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...
What is the current status of trial NCT03677245?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2018-11-26. Estimated completion is 2019-06-01.
What conditions does trial NCT03677245 study?
This clinical trial studies the following conditions: Down Syndrome, Postural Balance.
What interventions are being tested in trial NCT03677245?
The interventions under investigation include: Strider Balance Bike (OTHER).
Who is sponsoring clinical trial NCT03677245?
This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03677245 being conducted?
This trial has 1 study location across Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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