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

ConditionDown Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-13
SponsorUniversity of Southern California

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Down syndrome

10-13 months of age

Able to sit independently

Unable to walk independently

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: walker interventionExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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