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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 is a NA study that has completed, run by University of St. Augustine for Health Sciences. The registered enrollment target is 17 participants.
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.
Interventions
- OTHER Hip Helpers home program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-05-05 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04603352
The ClinicalTrials.gov registry entry for NCT04603352 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of St. Augustine for Health Sciences, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hip Helpers home program is the first listed.
NCT04603352 reports 0 study locations.
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.
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