Home and Community Use of a Suspension Walker in Pre-Walking Infants With Down Syndrome

Sponsor
University of Southern California
Study ID
NCT07631130
Status
Not Yet Recruiting

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Conditions

  • Down Syndrome

Eligibility Criteria

Sex
ALL
Age
10 Months - 13 Months
Healthy Volunteers
Not accepted

Interventions

  • suspension walker — BEHAVIORAL
    Parents will be provided with a pediatric suspension walker and instructed to use the walker with their infant at least 20 total min/day, 5 days/week. Parents will be instructed in 3 activity types: 1) Adult-propelled stepping consists of the caregiver moving the walker along the floor to prompt the infant to step. 2) Self-propelled walking consists of encouraging the infant to step independently to propel the walker, with intermittent assistance from the caregiver as needed. 3) Play consists of a variety of mobile and stationary play activities, adapted to the child's interests, engaged in while supported in the walker. Parents will brainstorm with the therapist to select play activities and to determine where and when to perform stepping and walking activities. This may include home- and community-based locations, including larger rooms in the home, hallways, sidewalks, parks, and indoor community spaces like supermarkets or shopping malls.

Study Details

The goal of this clinical trial is to learn if pre-walking infants with Down syndrome can use a suspension walker in their home and community environments. The main questions it aims to answer are: * Is suspension walker intervention feasible for pre-walking infants with Down syndrome? * What are barriers to successfully using suspension walkers in home and community environments? * What are facilitators for successfully using suspension walkers in home and community environments? Participants will: * Use a suspension walker in the home and community for a three-month period (goal 20 minutes/day, 5 days/week) * Meet with a therapist three times in their home to learn how to use the walker * Track how often they use the walker for one week each month * Complete assessments of infants' gross motor skill and ability to use the walker before and after the three-month period * Be interviewed after the three-month period about their experiences using the walker

Key Dates

First listed
Jun 5, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: walker intervention
    walker intervention

Primary Outcome Measure

participation in instructed dosage [ Time Frame: first week of each month for three months ]

Central Contacts

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