Health TrialsbyHealthPanel

Harness-based Mobility Intervention for Infants With Down Syndrome

ConditionDown Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorBoston University Charles River Campus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Mosaic or Translocation Down syndrome

severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)

severe uncorrected hearing or vision impairments

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Body weight supported harnessExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean posture duration in seconds

Average time spent in supine, prone, sitting, standing

Time frame
6 months
2

Mean number of locomotion bouts

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

Time frame
6 months
3

Mean time spent in contact with objects

Average time infants spend touching objects

Time frame
6 months
4

Mean number of different objects contacted

Average number of unique objects touched

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston University Charles River Campus

Lead sponsor

Boston Children's Hospital

Collaborator

Source ClinicalTrials.gov
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