N/A
Completed N=4
Otteroo Case Series
Infants With or at Risk/Concern for Developmental Delay
Source: ClinicalTrials.gov NCT03502265 ↗
Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Change in Alberta Infant Motor Scale — 5 change in percentile
Summary
Rationale. The Otteroo is a floatie which supports an infant or young child with their head above and their body in water. Researchers are proposing that the Otteroo may be a good "tool" to facilitate exploring the ability to move and control one's body before locomotion develops. Intervention. Otteroo will be used as an adjunct to standard care for 4 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alberta Infant Motor Scale |
5 | — |
Eligibility Criteria
Inclusion Criteria
- pre-locomotor (able to locomote independently less than 4 feet)
- a healthcare provider or caregiver has identified concerns about potential developmental delay
Exclusion Criteria
- younger than 8 weeks of age
- older than 66 months of age
- body weight of more than 35 lbs
- diagnosis of Down syndrome
- clinical presentation of ligamentous laxity
- without access to an appropriate water source (bathtub or pool depending on the size of the child)
- with prior experience using Otteroo
Data sourced from ClinicalTrials.gov (NCT03502265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.