Harness-based Mobility Intervention for Infants With Down Syndrome
This study is looking at a body weight supported harness to help infants with Down syndrome (DS) develop mobility, like crawling and walking. These skills are important for exploring and learning. The study aims to see if using a harness can help infants with DS move more, communicate better, and interact socially. Researchers want to understand if this harness system is practical for families and how to best measure its effects. You might be able to join if your child has a confirmed diagnosis of Trisomy 21 (Down syndrome), is younger than 24 months, speaks English at home, can sit without help, and isn't yet taking independent steps. The study is currently unclear on its recruitment status.
- Study design
- This study is an interventional study with a planned enrollment of 6 participants. It is not specified if it is randomized or blinded.
- What's involved
- You and your child will have 12 observations over 6 months, with one in-person and one virtual (Zoom) visit each month. You will use the harness for 30 minutes a day, 5 days a week, for one month and keep a daily log. Your child will also have assessments like the Bayley Scales of Infant and Toddler Development-4.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be observed for 6 months, with primary outcomes measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Harness-based Mobility Intervention for Infants With Down Syndrome
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jana Iverson, PhD · PRINCIPAL_INVESTIGATOR · Boston University
- Nicole Baumer, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mean posture duration in seconds6 months
Average time spent in supine, prone, sitting, standing
- Mean number of locomotion bouts6 months
Mean instances of crawling, cruising, walking, or other forms of locomotion
- Mean time spent in contact with objects6 months
Average time infants spend touching objects
- Mean number of different objects contacted6 months
Average number of unique objects touched
- Mean number of vocalizations6 months
Average number of speech-like sound productions
- Mean number of gestures6 months
Average number of gestures
- Proportion of directed vocalizations6 months
Proportion of total vocalizations accompanied by looking to the caregiver
- Proportion of directed gestures6 months
Proportion of total gestures accompanied by looking to the caregiver
- Bayley Scales of Infant Development-4Study entry, 3 months, 6 months
Comprehensive, standardized measure of general development for children from 1-42 months, with five subscales: Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior. Raw scores will be used. Minimum score is 0; there is no maximum score. Higher scores indicate a better outcome.
- Early Social Communication ScalesStudy entry, 3 months, 6 months
Structured experimenter-administered observation of nonverbal communication skills: assesses joint attention, requesting, and social interaction skills. Minimum score is 0. There is no maximum score. Higher scores mean a better outcome.
- MacArthur-Bates Communication Development Inventory: Words & GesturesStudy entry, 3 months, 6 months
Parent questionnaire identifying words that the child only understands and those that s/he both says and understands as well as production of early gestures (e.g., showing, pointing) and actions (e.g., games, routines). There are seven subscales. Raw scores will be reported for each one, and all have a minimum score of 0. Higher scores mean better outcomes. Words Understood (maximum score = 396) Words Produced (maximum score = 396) First Communicative Gestures (maximum score = 12) Games and Routines (maximum score = 6) Actions with Objects (maximum score = 17) Pretending to be a Parent (maximum score = 13) Imitating Other Adult Actions (maximum score = 15)