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

NCT07631130 | Not Yet Recruiting

• 1 other identifier: 26-02380
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Down Syndrome

Keywords

Down syndrome; infant; mobility device; walker; walking; early intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• usage frequency and duration

  first week of each month for three months

• steps per minute

  first week of each month for three months

• gross motor function

  0 and 3 months

• stepping ability

  0 and 3 months

• walker propulsion

  0 and 3 months

Study Arms (1)

walker intervention

EXPERIMENTAL

walker intervention

Behavioral: suspension walker

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.

walker intervention

Eligibility Criteria

• Age: 10 Months - 13 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

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

• Kari S Kretch, PT, DPT, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kari S Kretch

CONTACT

323-442-3364; kretch@usc.edu

Learning, Development, and Rehabilitation Lab

CONTACT

(323) 442-3119; learninglab@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: at the time of publication of results