Down SyndromeNCT07631130
Home and Community Use of a Suspension Walker in Pre-Walking Infants With Down Syndrome
A study testing suspension walker in people with Down Syndrome, run by University of Southern California.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 13 months
- Conditions the study is for
- Down Syndrome
- What is being tested?
- suspension walker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Down syndrome
- 10-13 months of age
- Able to sit independently
- Unable to walk independently
Who cannot join
- Medical or orthopedic conditions other than Down syndrome that prevent standing or walking
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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
- Being tested
- suspension walker
- Keywords
- Down syndrome, infant, mobility device, walker, walking, early intervention
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suspension walkerBehavioural
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 group | Role | What they receive |
|---|---|---|
| walker intervention | Experimental | walker intervention Receives: Behavioral: suspension walker |
What is being measured
The primary outcome is the main question the study is designed to answer.
participation in instructed dosage
Dichotomous: Was the family able to use the walker for the instructed 20 minutes/day, 5 days/week?
Measured: first week of each month for three months
Secondary outcomes (5)
usage frequency and duration
minutes per day, days per week
Measured: first week of each month for three months
steps per minute
steps per minute while using walker (measured by StepWatch step counters)
Measured: first week of each month for three months
gross motor function
Gross Motor Function Measure-88
Measured: 0 and 3 months
stepping ability
rate of alternating steps while the walker is moved by an adult
Measured: 0 and 3 months
walker propulsion
Dichotomous: Was the infant able to propel the walker without assistance?
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Kretch, University of Southern California
- Investigators
- Kari S Kretch, PT, DPT, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631130
- Sponsor's protocol ID
- 26-02380
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all non-identifiable IPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Novel Overground Stepping Intervention for Pre-Walking Infants With Down Syndrome
- ClinicalTrials.gov ID
- NCT07631130
- Acronym / sponsor ID
- 26-02380
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, infant, mobility device, walker, walking, early intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| walker intervention | Experimental | Behavioral: suspension walkerwalker intervention |
Who may qualify
- Ages
- 10 to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of Down syndrome
- 10-13 months of age
- Able to sit independently
- Unable to walk independently
Key exclusion criteria (1 listed)
- Medical or orthopedic conditions other than Down syndrome that prevent standing or walking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suspension walkerParents 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. | Behavioural | walker intervention |
Primary outcome
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?
5 secondary outcomes
usage frequency and duration
Time frame: first week of each month for three months
steps per minute
Time frame: first week of each month for three months
gross motor function
Time frame: 0 and 3 months
stepping ability
Time frame: 0 and 3 months
walker propulsion
Time frame: 0 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. all non-identifiable IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kari S Kretch, PT, DPT, PhD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing suspension walker in people with Down Syndrome, run by University of Southern California.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kari S Kretch (323-442-3364, kretch@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
participation in instructed dosage (time frame: first week of each month for three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.