Orthotic Garment for Down Syndrome

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byMegan B Flores, PT, MPT, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of St. Augustine for Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests if special shorts called Hip Helpers® can help infants with Down syndrome develop motor skills faster. The shorts keep the baby's legs together to improve balance and muscle use. Infants who can't sit independently will wear these shorts to see if they learn to move better and faster.

Eligibility Criteria

This trial is for infants with Down syndrome, aged three to nine months, who can't sit up on their own yet. It's not suitable for those with other conditions affecting movement, medical issues that limit movement, or a history of hip problems.

Inclusion Criteria

I cannot sit up by myself without support.

I have been diagnosed with Down syndrome.

I am between 3 to 9 months old.

Exclusion Criteria

I have a medical condition that prevents me from moving freely.

I have a condition unrelated to Down syndrome that affects my ability to move.

I have had a hip displacement or dislocation in the past.

Participant Groups

The study tests if wearing Hip Helpers®, an orthotic garment designed as flexible shorts to improve posture and motor skills, helps these infants develop gross motor skills faster when used in a home program supervised by physical therapists.

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention group: Hip Helpers home programExperimental Treatment1 Intervention

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.

Group II: Control group: No additional home programActive Control1 Intervention

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