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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
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
Study Summary
This trial is investigating whether an inexpensive garment worn to keep upper legs together can help improve gross motor skill development in infants with Down syndrome.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Gross Motor Function Measure - 88 (GMFM-88
Secondary outcome measures
Incidence of gross motor milestone achievement, by parent report
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.
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Who is running the clinical trial?
University of St. Augustine for Health SciencesLead Sponsor
6 Previous Clinical Trials
433 Total Patients Enrolled
Megan B Flores, PT, MPT, PhDPrincipal InvestigatorUniversity of St. Augustine for Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a medical condition that prevents me from moving freely.I cannot sit up by myself without support.I have been diagnosed with Down syndrome.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.I am between 3 to 9 months old.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group: Hip Helpers home program
- Group 2: Control group: No additional home program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which individuals might be most suitable to take part in this research?
"Eligibility requirements for this clinical trial dictate that individuals must have Down syndrome and be between 3 and 15 months of age. The team is aiming to enrol 34 patients in total."
Answered by AI
Are any vacancies available for this clinical experiment?
"Evidenced by the clinicaltrials.gov database, this research initiative is actively seeking participants. It was initially published on May 5th 2021 and was most recently updated November 1st 2022."
Answered by AI
How extensive is the current sample size of this trial?
"Affirmative. According to the clinicaltrials.gov website, this research initiative has been open for applications since May 5th 2021 and was last amended on November 1st 2022. 34 individuals are being sought from 3 distinct medical centers."
Answered by AI
Is this trial open to seniors aged 60 or over?
"According to the criteria for participation, eligible patients must be between 3 and 15 months old. This trial is one of 383 clinical trials that involve minors and 986 targeting elderly adults."
Answered by AI
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