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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: Completed NA study of Down Syndrome and Postural Balance, sponsored by University of Mississippi Medical Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

Interventions

  • OTHER Strider Balance Bike

Study Locations (1)

Mississippi

  • University of Mississippi Wellness Center - Flowood

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2018-11-26
Est. Completion 2019-06-01
Phase NA

What the finished NCT03677245 record still lists

NCT03677245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 2,472-participant average among 54 other Down Syndrome trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Similar trials for Down Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03677245's enrollment target sits among peer trials

8 53rd of 54 higher than 2 of 54 other Down Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03677245, the US trial registry maintained by the National Library of Medicine. NCT03677245 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.