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

Completed · Not applicable

Conditions studied: Down Syndrome

In brief

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.

Key facts

Study ID

NCT04603352

Run by

University of St. Augustine for Health Sciences

People needed

17

Starts

2021-05-05

Expected to finish

2025-06-30

Last updated by the study team

2025-07-18

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of DS
• between the ages of three to nine months
• not able to maintain upright sitting independently

You may not qualify if…

• a diagnosis unrelated to DS that limits gross motor movement
• medical restrictions that contraindicate movement
• a history of hip displacement or dislocation

Where it is running

• University of St. Augustine for Health Sciences — San Marcos, California, United States
• University of St. Augustine for Health Sciences — Saint Augustine, Florida, United States
• University of St. Augustine for Health Sciences — Austin, Texas, United States

Full record on ClinicalTrials.gov

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