Otteroo Case Series

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploring Otteroo Use In Early Intervention: A Case Series

Conditions
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Infants With or at Risk/Concern for Developmental Delay

Intervention / Treatment
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* Other: Otteroo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 66 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single subject research design case series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Otteroo adjunct<br>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). There is only one arm due to the study design. It is a within-subjects comparison, not a between-subjects comparison of different study arms. | Other: Otteroo<br>* Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alberta Infant Motor Scale | 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. | weeks 0 and 12 |