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

NCT04603352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-07-18

No results posted yet for this 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.

Conditions

  • Down Syndrome

Interventions

OTHER

Hip Helpers home program

Home program: Infants will wear Hip Helpers 30 minutes, twice per day.

Sponsors & Collaborators

  • University of St. Augustine for Health Sciences

    lead OTHER

Principal Investigators

  • Megan B Flores, PT, MPT, PhD · University of St. Augustine for Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04603352 on ClinicalTrials.gov