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NCT Number: NCT07631130

Home and Community Use of a Suspension Walker in 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

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Key information

Conditions

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

Age range

10 month–13 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. participation in instructed dosage

    Time frame: first week of each month for three months

    Dichotomous: Was the family able to use the walker for the instructed 20 minutes/day, 5 days/week?

Secondary outcomes

  1. usage frequency and duration

    Time frame: first week of each month for three months

    minutes per day, days per week

  2. steps per minute

    Time frame: first week of each month for three months

    steps per minute while using walker (measured by StepWatch step counters)

  3. gross motor function

    Time frame: 0 and 3 months

    Gross Motor Function Measure-88

  4. stepping ability

    Time frame: 0 and 3 months

    rate of alternating steps while the walker is moved by an adult

  5. walker propulsion

    Time frame: 0 and 3 months

    Dichotomous: Was the infant able to propel the walker without assistance?

Study contacts

Contact information is provided by the study sponsor or research team.

Kari S Kretch

CONTACT

[email protected]

323-442-3364

Learning, Development, and Rehabilitation Lab

CONTACT

[email protected]

(323) 442-3119

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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