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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| walker intervention | Experimental | walker intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| participation in instructed dosage | Dichotomous: Was the family able to use the walker for the instructed 20 minutes/day, 5 days/week? | first week of each month for three months |
| Measure | Description | Time Frame |
|---|---|---|
| usage frequency and duration | minutes per day, days per week | first week of each month for three months |
| steps per minute | steps per minute while using walker (measured by StepWatch step counters) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kari S Kretch | Contact | 323-442-3364 | kretch@usc.edu | |
| Learning, Development, and Rehabilitation Lab | Contact | (323) 442-3119 | learninglab@usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kari S Kretch, PT, DPT, PhD | University of Southern California | Principal Investigator |
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all non-identifiable IPD
at the time of publication of results
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| first week of each month for three months |
| gross motor function | Gross Motor Function Measure-88 | 0 and 3 months |
| stepping ability | rate of alternating steps while the walker is moved by an adult | 0 and 3 months |
| walker propulsion | Dichotomous: Was the infant able to propel the walker without assistance? | 0 and 3 months |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |