Otteroo Case Series

University of Southern California

Status: Completed

Conditions: Infants With or at Risk/Concern for Developmental Delay

Treatments: Other: Otteroo

Study type: Interventional

Funder types: Other

Identifiers

NCT03502265

HS-17-00910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 8 weeks to 66 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Otteroo adjunct

Experimental group

Description:

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.

Treatment:

Other: Otteroo