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Behavioural Intervention

Body weight supported harness for Down Syndrome

N/A

Waitlist Available

Led By Nicole Baumer, MD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study entry, 3 months, 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study entry, 3 months, 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bayley Scales of Infant Development-4

Early Social Communication Scales

MacArthur-Bates Communication Development Inventory: Words & Gestures

+8 more

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor

114 Previous Clinical Trials

12,284 Total Patients Enrolled

Boston Children's HospitalOTHER

762 Previous Clinical Trials

5,579,928 Total Patients Enrolled

4 Trials studying Down Syndrome

120 Patients Enrolled for Down Syndrome

Nicole Baumer, MDPrincipal InvestigatorBoston Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"Based on the information available on clinicaltrials.gov, this particular study is not actively seeking participants at this time. The trial was initially posted on February 1st, 2024 and last updated on January 12th, 2024. However, it's worth noting that there are currently 1453 alternative studies actively enrolling patients for those interested in participating in a clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Harness-based Mobility Intervention for Infants With Down Syndrome

Jana M. Iverson 2024. "Harness-based Mobility Intervention for Infants With Down Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06219863.

All > Down Syndrome