NCT03502265

Otteroo Case Series

Exploring Otteroo Use In Early Intervention: A Case Series

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 8 Weeks – 66 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives or purpose. The purpose of this project is to measure overall developmental status before, during, and after Otteroo experience. Study population or sample characteristics. Participants will be 4 pre-locomotor infants or young children for whom a healthcare provider or caregiver has identified concerns about potential developmental delay. Study methodology. A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). Study endpoints or outcomes. The end of the study is the final assessment at 12 weeks. Follow-up. None. Statistics and plans for analysis. Researchers will calculate descriptive statistics (mean, range, coefficient of variation) for all measures and describe changes over time, relating the participant's performance at each time point to norm-referenced results for their age.

Conditions

• Infants With or at Risk/Concern for Developmental Delay

Interventions

Type	Name	Description
OTHER	Otteroo	Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.

Timeline

• Start date: 2018-04-03
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2018-04-18
• Last updated: 2021-11-23
• Results posted: 2021-10-27

Locations

1 site across 1 country: United States