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| Name | Class |
|---|---|
| Duquesne University | OTHER |
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The goal of this clinical trial is to test whether an app-based intervention can reduce the likelihood of a torticollis diagnosis in infants. The main question[s] it aims to answer are:
Participants will complete a monthly survey for 6 months asking about their parenting behaviors. Researchers will compare parents who receive notifications about torticollis with parents who receive notifications about general infant development to see if increased knowledge of torticollis leads to preventive behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | in-app twice-weekly parent notification about torticollis and head turn asymmetries |
|
| control | No Intervention | in-app twice-weekly parent notification about general infant development |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in-app notification | Behavioral | Parents will receive bi-weekly prompts in a baby monitor app to change infant's orientation within crib, allow for tummy time several times per day, alternate the side from which infants are fed, alternate the side the infant faces during carrying, and in general note any side preferences of the infant so that positioning can assist in symmetry. |
| Measure | Description | Time Frame |
|---|---|---|
| symmetry score | extent of infant's head turn asymmetry | baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| gaze asymmetry score | extent of infant's eye gaze asymmetry | 6 months |
| time spent in focused attention | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Individual participant data that underlie results reported in published articles, after deidentification, as well as the study protocol, statistical analysis plan, and informed consent form, will be available beginning 9 months and ending 5 years following publication.
Only investigators whose proposed use of the data has been approved by a learned intermediary shall have access to conduct analyses as approved in the proposal.
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| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| # of bouts of focused attention |
| 6 months |
| correlation between computer vision algorithm & manual coding for infants' head turns | 4 months |
| Correlate computer vision score with clinical test of symmetry | 4 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |