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

Feasibility of a Novel Overground Stepping Intervention for Pre-Walking Infants With Down Syndrome

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

Study Overview

• Status: Not yet recruiting
• Conditions: Down Syndrome
• Intervention / Treatment: Behavioral: suspension walker

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kari S Kretch; Phone Number: 323-442-3364; Email: kretch@usc.edu
• Study Contact Backup: Name: Learning, Development, and Rehabilitation Lab; Phone Number: (323) 442-3119; Email: learninglab@usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Down syndrome
• 10-13 months of age
• Able to sit independently
• Unable to walk independently

Exclusion Criteria:

• Medical or orthopedic conditions other than Down syndrome that prevent standing or walking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: walker intervention

Behavioral: suspension walker; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
participation in instructed dosage	Dichotomous: Was the family able to use the walker for the instructed 20 minutes/day, 5 days/week?	first week of each month for three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
usage frequency and duration	minutes per day, days per week	first week of each month for three months
steps per minute	steps per minute while using walker (measured by StepWatch step counters)	first week of each month for three months
gross motor function	Gross Motor Function Measure-88	0 and 3 months
stepping ability	rate of alternating steps while the walker is moved by an adult	0 and 3 months
walker propulsion	Dichotomous: Was the infant able to propel the walker without assistance?	0 and 3 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Kari S Kretch, PT, DPT, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: walking; early intervention; Down syndrome; infant; walker; mobility device
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Congenital Abnormalities; Abnormalities, Multiple; Intellectual Disability; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Down Syndrome
• Other Study ID Numbers: 26-02380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all non-identifiable IPD
• IPD Sharing Time Frame: at the time of publication of results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No