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 volunteersQualifiers
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
Single group
Treatments tested in this trial
suspension walker
BehavioralParents 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
Trial outcomes
Primary outcomes
participation in instructed dosage
Dichotomous: Was the family able to use the walker for the instructed 20 minutes/day, 5 days/week?
Secondary outcomes
usage frequency and duration
minutes per day, days per week
steps per minute
steps per minute while using walker (measured by StepWatch step counters)
gross motor function
Gross Motor Function Measure-88
stepping ability
rate of alternating steps while the walker is moved by an adult
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: