What is the mechanism of action of this treatment?

Common treatments for Down Syndrome, particularly those aimed at improving gross motor skills and postural control, often involve physical therapy and the use of orthotic devices. The Hip Helpers® orthotic garment, for instance, promotes a narrow base of support, encouraging the activation of upright postural muscles. This is important for Down Syndrome patients as it aids in the development of gross motor skills, which are usually delayed. By enhancing postural control and muscle activation, these treatments improve mobility, balance, and overall physical function, thereby significantly enhancing the quality of life for individuals with Down Syndrome.

What side effects are associated with this type of intervention?

Orthotic garments like Hip Helpers® and other physical therapy interventions for Down Syndrome generally aim to improve gross motor skills and postural stability. Common side effects of using orthotic devices may include skin irritation, discomfort, or pressure sores due to prolonged wear. Physical therapy, while beneficial, can sometimes lead to muscle soreness or fatigue. It is important for caregivers to monitor for these side effects and consult with healthcare providers to ensure proper fit and usage.

What prior FDA approvals exist?

There are no FDA-approved drugs specifically for the treatment of Down Syndrome that focus on improving gross motor skills through physical support similar to the Hip Helpers® orthotic garment. Current treatments for Down Syndrome primarily involve physical therapy, occupational therapy, and supportive devices to aid in motor development and overall functionality.

What other types of research exist?

Promising alternatives to the Hip Helpers® orthotic garment for Down Syndrome patients include: 1) Dynamic orthoses that provide adjustable support and feedback to encourage proper posture and movement patterns. 2) Wearable robotic exoskeletons designed for children, which assist in walking and standing while promoting muscle activation. 3) Virtual reality-based physical therapy programs that engage children in interactive exercises to improve balance and motor skills. 4) Advanced neuromuscular electrical stimulation (NMES) devices that target specific muscle groups to enhance strength and coordination.

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Orthotic Garment for Down Syndrome

N/A

Waitlist Available

Led By Megan B Flores, PT, MPT, PhD

Research Sponsored by University of St. Augustine for Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not able to maintain upright sitting independently

Diagnosis of DS

Must not have

Medical restrictions that contraindicate movement

A diagnosis unrelated to DS that limits gross motor movement

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves wearing an orthotic garment and does not include medication or invasive procedures, no direct side effects are expected. However, discomfort or skin irritation could potentially occur from the garment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot sit up by myself without support.

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I have been diagnosed with Down syndrome.

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I am between 3 to 9 months old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 4 weeks from randomization until child takes three independent steps, up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 4 weeks from randomization until child takes three independent steps, up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 4 weeks from randomization until child takes three independent steps, up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Incidence of gross motor milestone achievement, by parent report

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Down Syndrome, particularly those aimed at improving gross motor skills and postural control, often involve physical therapy and the use of orthotic devices. The Hip Helpers® orthotic garment, for instance, promotes a narrow base of support, encouraging the activation of upright postural muscles. This is important for Down Syndrome patients as it aids in the development of gross motor skills, which are usually delayed. By enhancing postural control and muscle activation, these treatments improve mobility, balance, and overall physical function, thereby significantly enhancing the quality of life for individuals with Down Syndrome.

The Influence of the Physiotherapeutic Program on Selected Static and Dynamic Foot Indicators and the Balance of Elderly Women Depending on the Ground Stability.A preliminary study to evaluate postural improvement in subjects with scoliosis: active therapeutic movement version 2 device and home exercises using the Mulligan's mobilization-with-movement concept.Preliminary trial of postural strategy training using a personal transport assistance robot for patients with central nervous system disorder.