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Otteroo Case Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03502265
Recruitment Status : Completed
First Posted : April 18, 2018
Results First Posted : October 27, 2021
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Beth A. Smith, University of Southern California

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Infants With or at Risk/Concern for Developmental Delay Other: Otteroo Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: single subject research design case series
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring Otteroo Use In Early Intervention: A Case Series
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Other: Otteroo
Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Weeks to 66 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502265


Locations
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United States, California
Infant Neuromotor Control Laboratory
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
  Study Documents (Full-Text)

Documents provided by Beth A. Smith, University of Southern California:
Study Protocol and Statistical Analysis Plan  [PDF] March 8, 2018

More Information
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Responsible Party: Beth A. Smith, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03502265    
Other Study ID Numbers: HS-17-00910
First Posted: April 18, 2018    Key Record Dates
Results First Posted: October 27, 2021
Last Update Posted: November 23, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: available upon request from the PI (Beth Smith)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: available for 3 years following publication of results in peer-reviewed journal
Access Criteria: available upon request from the PI (Beth Smith) at beth.smith@usc.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No