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Otteroo Case Series

NCT ID: NCT03502265

Last Updated: 2021-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2019-09-01

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.

Conditions

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Infants With or at Risk/Concern for Developmental Delay

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single subject research design case series
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Otteroo adjunct

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.

Group Type EXPERIMENTAL

Otteroo

Intervention Type OTHER

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

Interventions

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Otteroo

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

Intervention Type OTHER

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
Minimum Eligible Age

8 Weeks

Maximum Eligible Age

66 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Beth A. Smith

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Infant Neuromotor Control Laboratory

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HS-17-00910

Identifier Type: -

Identifier Source: org_study_id