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NCT04603352 · ClinicalTrials.gov registry record · NA

Impact of an Orthotic Garment on Gross Motor Skills for Infants With Down Syndrome

A NA study, sponsored by University of St. Augustine for Health Sciences.

Completed
Registry status
NA
Development phase
17
Enrollment target

NCT04603352: Completed NA study, sponsored by University of St. Augustine for Health Sciences.

NCT04603352 is a NA study that has completed, run by University of St. Augustine for Health Sciences. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04603352, a NA study, has completed, sponsored by University of St. Augustine for Health Sciences.

COMPLETED
Registry status
NA
Development phase
17 participants
Enrollment target

Study Summary

Infants with Down syndrome (DS) develop slower than their typically developing peers. Physical therapist (PT) supervised home programs have the potential to optimize gross motor development in a financially feasible way. An inexpensive orthotic garment (Hip Helpers®) is commonly employed by PTs as a home program supplement, but its effectiveness has not yet been investigated. The garment is worn as pliable shorts over a child's lower extremities to keep upper legs together, promoting a narrow base of support. This encourages activation of upright postural muscles to improve gross motor skill development. The purpose of this randomized controlled study is to investigate the impact of a home program using the Hip Helpers® orthotic garment on gross motor skill acquisition in infants with DS. We hypothesize that the addition of a structured home program using Hip Helpers®, supervised by a PT and implemented by parents, will increase the rate at which infants with DS acquire gross motor skills. Thirty-four participants, consisting of children who are at least three-months-old and are not yet able maintain sitting independently, will be randomly assigned to a control (n=17) or intervention group (n=17). PTs at pediatric therapy agencies will initiate the home program and administer the Gross Motor Function Measure-88 (GMFM-88) at regular intervals to monitor gross motor skill acquisition until the child is able to take three independent steps. Groups will be compared on the length of time elapsed between the acquisition of identified gross motor skills using independent t-tests. GMFM-88 scores will be compared between the two groups at different ages to identify trends using independent t-tests. The contribution of this project will be significant by informing physical therapists about the effectiveness of an inexpensive orthotic garment used in a supervised home program on gross motor outcomes in infants with DS.

Primary Outcome

The GMFM-88 is a measure of gross motor function for children with Down syndrome (DS) under six years old. The examiner scores a child's capabilities across five dimensions of functional movement: A) Lying and Rolling, B) Sitting, C) Crawling and Kneeling, D) Standing, and E) Walking, Running, and Jumping. Each dimension consists of several items on an ordinal scale. The child receives a score of 0 (does not initiate), 1 (initiates), 2 (partially completes), or 3 (completes). This outcome measur

Interventions

  • OTHER Hip Helpers home program

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-05-05
Est. Completion 2025-06-30
Phase NA

What the finished NCT04603352 record still lists

NCT04603352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Hip Helpers home program is the first listed.

NCT04603352 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04603352 about?

NCT04603352 is a clinical study titled "Impact of an Orthotic Garment on Gross Motor Skills for Infants With Down Syndrome". Infants with Down syndrome (DS) develop slower than their typically developing peers. Physical therapist (PT) supervised home programs have the potential to optimize gross motor development in a financially feasible way. An inexpensive orthotic garment (Hip Helpers®) is commonly employed by PTs as a...

What is the current status of trial NCT04603352?

This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2021-05-05. Estimated completion is 2025-06-30.

What interventions are being tested in trial NCT04603352?

The interventions under investigation include: Hip Helpers home program (OTHER).

Who is sponsoring clinical trial NCT04603352?

This trial is sponsored by University of St. Augustine for Health Sciences, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04603352's enrollment target sits among peer trials

17 1871st of 2000 higher than 130 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT04603352, the US trial registry maintained by the National Library of Medicine. NCT04603352 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.