Down Syndrome
Conditions
Keywords
Down syndrome, infant, mobility device, walker, walking, early intervention
Brief 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
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.
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Months to 13 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| participation in instructed dosage | 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
| Measure | Time frame | Description |
|---|---|---|
| usage frequency and duration | first week of each month for three months | minutes per day, days per week |
| steps per minute | first week of each month for three months | steps per minute while using walker (measured by StepWatch step counters) |
| gross motor function | 0 and 3 months | Gross Motor Function Measure-88 |
| stepping ability | 0 and 3 months | rate of alternating steps while the walker is moved by an adult |
| walker propulsion | 0 and 3 months | Dichotomous: Was the infant able to propel the walker without assistance? |
Contacts
CONTACTKari S Kretch
CONTACTLearning, Development, and Rehabilitation Lab
PRINCIPAL_INVESTIGATORKari S Kretch, PT, DPT, PhD
University of Southern California
Outcome results
None listed