Harness-based Mobility Intervention for Infants With Down Syndrome

NCT06219863 | Recruiting

• 1 other identifier: 6930E
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The emergence of crawling and walking is significantly delayed in infants with Down syndrome (DS), but the development of independent mobility provides infants with new opportunities for exploring the environment and interacting with objects and people that are important foundations for early learning. Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and social interaction. This project will set the stage for the first clinical trial of a mobility-related intervention specifically tailored for infants with DS by testing the feasibility of harness systems with infants and families and identifying measures that will serve as primary outcome variables. Upon completion of this pilot project, necessary preliminary data and experience required for an in-home, high-impact clinical trial for infants with DS will have been obtained.

Conditions

Down Syndrome

Keywords

infant

Outcome Measures

Primary Outcomes (11)

• Mean posture duration in seconds

  Average time spent in supine, prone, sitting, standing

  6 months

• Mean number of locomotion bouts

  Mean instances of crawling, cruising, walking, or other forms of locomotion

  6 months

• Mean time spent in contact with objects

  Average time infants spend touching objects

  6 months

• Mean number of different objects contacted

  Average number of unique objects touched

  6 months

• Mean number of vocalizations

  Average number of speech-like sound productions

  6 months

• Mean number of gestures

  Average number of gestures

  6 months

• Proportion of directed vocalizations

  Proportion of total vocalizations accompanied by looking to the caregiver

  6 months

• Proportion of directed gestures

  Proportion of total gestures accompanied by looking to the caregiver

  6 months

• Bayley Scales of Infant Development-4

  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.

  Study entry, 3 months, 6 months

• Early Social Communication Scales

  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.

  Study entry, 3 months, 6 months

• MacArthur-Bates Communication Development Inventory: Words & Gestures

  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)

  Study entry, 3 months, 6 months

Study Arms (1)

Body weight supported harness

EXPERIMENTAL

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.

Behavioral: Body weight supported harness

Interventions

Body weight supported harness BEHAVIORAL

A body weight supported harness will be provided to families for one month to set up in their home. Caregivers will be asked to use the harness for their infants for 30 min per day, 5 days a week. Caregivers will complete a daily log describing harness use. At the end of the month, they will complete feasibility and acceptability questionnaires.

Body weight supported harness

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Jana Iverson, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Nicole Baumer, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Donato

CONTACT

(774) 275-3321; buicl.studies@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christopher A. Moore Professor of Pediatric Rehabilitation

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 23, 2024
• Study Start: July 31, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after study completion
• Access Criteria: Access granted to approved users of the INCLUDE database

Locations

US (1)