Otteroo Case Series

Infants With or at Risk/Concern for Developmental Delay Clinical Trial

Official title:

Exploring Otteroo Use In Early Intervention: A Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502265
• Other study ID #: HS-17-00910
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Weeks to 66 Months

Eligibility

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

Related Conditions & MeSH terms

• Infants With or at Risk/Concern for Developmental Delay

Intervention

Other:
• Otteroo
Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.

Locations

Country	Name	City	State
United States	Infant Neuromotor Control Laboratory	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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