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Not yet recruitingNCT07631130Updated Jun 5, 2026

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

An interventional study of suspension walker in Down Syndrome, sponsored by University of Southern California. Not yet recruiting. Open to participants aged 10 Months to 13 Months. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by University of Southern California · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
10 Months to 13 Months
Sex
All
01

Study 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
02

Conditions studied

  • Down Syndrome

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Keywords

  • Down syndrome
  • infant
  • mobility device
  • walker
  • walking
  • early intervention
03

In context

Down Syndrome

438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.

This study's planned enrollment of 12 is below the median of 37 across 286 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.

Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Months to 13 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Medical or orthopedic conditions other than Down syndrome that prevent standing or walking
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    walker intervention

    walker intervention

    Behavioral: suspension walker

Interventions

  • Behavioralsuspension 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.

06

What researchers measure

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?

    Time frame: first week of each month for three months

Secondary outcomes

  1. usage frequency and duration

    minutes per day, days per week

    Time frame: first week of each month for three months

  2. steps per minute

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

    Time frame: first week of each month for three months

  3. gross motor function

    Gross Motor Function Measure-88

    Time frame: 0 and 3 months

  4. stepping ability

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

    Time frame: 0 and 3 months

  5. walker propulsion

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

    Time frame: 0 and 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — all non-identifiable IPD

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: at the time of publication of results

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07631130
Responsible party
Kari Kretch (Assistant Professor, University of Southern California) — Principal investigator
First posted
Jun 5, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Jun 5, 2026

Study contacts

Kari S Kretch
Contact
kretch@usc.edu
323-442-3364
Learning, Development, and Rehabilitation Lab
Contact
learninglab@usc.edu
(323) 442-3119
Kari S Kretch, PT, DPT, PhD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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