Harness-based mobility intervention for infants with Down syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to enhance mobility in infants with Down syndrome by using body weight supported harness systems. The study will involve home visits and virtual sessions where infants and caregivers will be observed during playtime, both with and without the harness. Data will be collected on language and locomotor development, as well as the feasibility and acceptability of the harness system. The goal is to gather preliminary data to support a larger clinical trial focused on improving mobility and social interaction in these infants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* confirmed diagnosis of Trisomy 21
* younger than 24 months
* English is the primary language of the home (due to use of standardized language assessments normed on English-speaking children)
* able to sit without support
* not yet taking any independent steps.

Exclusion Criteria:

* Mosaic or Translocation Down syndrome
* severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
* severe uncorrected hearing or vision impairments

Where it's running

• Boston University
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jana Iverson, PhD — Boston University
• Study coordinator: Anna Donato
• Email: buicl.studies@gmail.com
• Phone: (774) 275-3321

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• JAK inhibitor treatment for Down syndrome in children and young adults

  This study tests whether 6 months of tofacitinib can help improve safety and neurodevelopment in people with Down syndrome aged 6 to 22, compared with placebo.

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• Jump rope to improve navicular drop and foot posture in children with Down syndrome

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• Thymus removal and immune aging in people with Down syndrome

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  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07416201

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.