Infant Neuromotor Control Laboratory
Los Angeles, California, 90089, United States
Completed
NCT Number: NCT03502265
Otteroo Case Series
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.
Completed
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Notify MeKey information
Age range
8 week–66 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Otteroo
OtherOtteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.
Primary outcomes
-
Change in Alberta Infant Motor Scale
Time frame: weeks 0 and 12
observational scale of motor skills, change in percentile score from week 0 to week 12 for each child. Full percentile range is 0-100%. Change of 0 means no change in percentile score, change of 100 means child went from 0% to 100% or 100% to 0% which is the maximum possible change in percentile score. A positive change means the percentile increased, while a negative change means the percentile decreased.
Sponsors and collaborators
Lead sponsor
University of Southern California
Other
Registry information
Official study title
Exploring Otteroo Use In Early Intervention: A Case Series
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Apr 18, 2018
- Registry last updated
- Nov 23, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.