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

NCT04603352 | Completed

• 1 other identifier: Down Syndrome Hip Helpers
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Down syndrome; Gross motor function; home program; orthotic garment

Outcome Measures

Primary Outcomes (1)

• Change in Gross Motor Function Measure - 88 (GMFM-88

  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 measure can be administered by direct observation or by parent report. For children with DS, the GMFM-88 has strong interrater reliability (ICC = 0.9

  Assessed every 4 weeks from randomization until child takes three independent steps, up to 36 months

Secondary Outcomes (1)

• Incidence of gross motor milestone achievement, by parent report

  From date of randomization at each documented progression until child takes three independent steps, assessed up to 36 months.

Study Arms (2)

Intervention group: Hip Helpers home program

EXPERIMENTAL

Participants in the intervention group will be given a custom pair of Hip Helpers® to use at home. Parents will begin the Hip Helpers® home program upon study entry and stop the program once the child is able to pull to stand independently. The Hip Helpers® home program protocol, which consists of using the orthotic garment twice daily for 30 minutes each time, will be given to the parents and supervised by the physical therapist. The Hip Helpers® should be donned when the child is actively playing, and not used sleep or when child is inactive.

Other: Hip Helpers home program

Control group: No additional home program

NO INTERVENTION

Participants assigned to the control group will continue with their usual care.

Interventions

Hip Helpers home program OTHER

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

Also known as: Orthotic garment home program

Intervention group: Hip Helpers home program

Eligibility Criteria

• Age: 3 Months - 15 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of St. Augustine for Health Sciences: lead

Study Sites (3)

University of St. Augustine for Health Sciences

San Marcos, California, 92069, United States

Location

University of St. Augustine for Health Sciences

Saint Augustine, Florida, 32086, United States

Location

University of St. Augustine for Health Sciences

Austin, Texas, 78739, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Megan B Flores, PT, MPT, PhD

  University of St. Augustine for Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This prospective, exploratory research study will employ a randomized controlled trial research design. The independent variables will be two conditions: usual care with the addition of a Hip Helpers® orthotic garment home program and usual care with no addition to the home program. The dependent variable will be an assessment of gross motor function over time as measured by the GMFM-88. Participants will be tested on the GMFM-88 each month, regardless of group.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: May 5, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)