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Behavioural Intervention

Harness-Based Mobility Intervention for Infants With Down Syndrome

N/A
Recruiting
Led By Jana Iverson, PhD
Research Sponsored by Boston University Charles River Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to sit without support and not yet taking any independent steps
Confirmed diagnosis of Trisomy 21
Must not have
Mosaic or Translocation Down syndrome
Severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study entry, 3 months, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the effects of using harness systems to help infants with Down syndrome (DS) to crawl and walk. It will test if these systems are feasible and effective in improving mobility, communication

Who is the study for?
This trial is for infants with Down syndrome to help them develop mobility skills like crawling and walking. It's designed to see if using a body weight supported harness can aid their movement, exploration, and social interaction.
What is being tested?
The study is testing the use of a special harness that supports an infant's body weight. This may help infants with Down syndrome move more easily, which could lead to better learning opportunities through exploration and interaction.
What are the potential side effects?
Since this trial involves physical support equipment for infants, potential side effects might include skin irritation from the harness or discomfort while using it. The exact side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can sit without help but cannot walk on my own.
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I have been diagnosed with Down syndrome.
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I am under 2 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a specific type of Down syndrome.
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I do not have severe, uncontrolled medical issues like unstable heart disease or epilepsy.
Select...
I have severe hearing or vision problems that cannot be corrected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study entry, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and study entry, 3 months, 6 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
Bayley Scales of Infant Development-4
Early Social Communication Scales
MacArthur-Bates Communication Development Inventory: Words & Gestures
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Body weight supported harnessExperimental Treatment1 Intervention
Harness is set up in families' homes for one month. Caregivers re asked to use the harness with their infant for 30 min/day, 5 times a week.

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor
120 Previous Clinical Trials
13,361 Total Patients Enrolled
Boston Children's HospitalOTHER
785 Previous Clinical Trials
5,581,725 Total Patients Enrolled
4 Trials studying Down Syndrome
139 Patients Enrolled for Down Syndrome
Jana Iverson, PhDPrincipal InvestigatorBoston University
~3 spots leftby Mar 2025
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