Exploring Otteroo Use In Early Intervention: A Case Series
Phase: NA
Conditions: Infants With or at Risk/Concern for Developmental Delay
Sponsor: University of Southern California

NCT03502265  
Otteroo Case Series  
Uploaded September 28, 2021  
IRB approval date: 3/8/2018. University of Southern California Health Sciences Institutional 
Review Board (HS-17-00910)  
 
Protocol 
  
Significance and justification for use  
  
The goal of this project is to measure overall developmental status before and 
after Otteroo experience in pre-locomotor infants and young children for whom a 
healthcare provider or caregiver has identified concerns about potential developmental 
delay. We are proposing that the Otteroo may be a good “tool” to facilitate 
early movement 
and 
exploration 
of the 
ability 
to 
move 
and 
control 
one’s 
body. The Otteroo is a widely-available commercial floatie marketed to families as “a 
floatie for babies ages 8 weeks +” (https://otteroo.com/).  
  
The Otteroo is a floatie which supports an infant or young child with their head above and 
their body in water. The Otteroo allows them to move around in water under direct 
caregiver supervision and within arm’s reach without the need for the caregiver to 
physically support the infant or child. As water provides a reduced-gravity environment, it 
allows infants and young children an opportunity to explore their ability to move and 
control their bodies more easily than when they are in a ‘typical gravity’ environment. 
Research has shown that infants are initially able to move their limbs against gravity in a 
stepping pattern, then go through a period of rapid weight gain that is not matched by a 
concurrent strength gain, and thus ‘lose’ the ability to step against gravity as they are not 
strong enough to lift their heavier limbs. Supporting them in water, however, allows them 
to perform stepping movements during the period when they otherwise would not be 
strong enough (1). While typically-developing infants move through this developmental 
progression, infants with motor delays can get ‘stuck’ in this period. As a result of their 
difficulty moving, they continue to physically grow but may not gain the requisite strength 
and may not optimally explore their ability to move and control their bodies during this 
foundational early developmental period (2). Children with developmental delays and 
disabilities are often recommended to participate in aquatic therapy to supplement clinic, 
early intervention, or school-based physical therapy or occupational therapy. One study 
with 37 children ages 6-30 months found that the aquatic therapy plus standard early 
intervention group demonstrated significantly greater gains in functional mobility than the 
comparison group of children who received standard early intervention only (3). Further, 
aquatic therapy has been explored as a useful intervention in clinically stable newborns 
of gestational age less than 36 weeks who were hospitalized in a neonatal intensive care 
unit (4). We propose that using the Otteroo to allow movement practice in a reduced-
gravity environment will allows infants to perform leg movements they otherwise would 
not be strong enough to perform, and this increased exploration and movement 
practice may have a positive impact on their development.   
  

Approach  
  
A pilot study sample of up to 4 infants/young children will participate. 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 4 weeks of reversal/retention period (standard care).  
  
Inclusion Criteria: Infants and young children who are pre-locomotor and for whom a 
healthcare provider or caregiver has identified concerns about potential developmental 
delay (see appendix 1).    
  
Exclusion Criteria: Infants younger than 8 weeks of age or with body weight of more than 
35 lbs will be excluded per the specifications of use of the Otteroo floatie. Children who 
are able to locomote independently more than 4 feet will be excluded 
as prelocomotor infants and young children are the target. Children older than 66 months 
of age will be excluded do to restrictions of the Ages and Stages measurement tool. 
Infants or children with a diagnosis of Down syndrome or with a clinical presentation of 
ligamentous laxity will be excluded due to concerns about atlanto-axial instability. Infant 
or children without access to an appropriate water source (bathtub or pool depending on 
the size of the child) will be excluded. Infants or children with prior experience 
using Otteroo will be excluded.  
  
Participant Recruitment:    
  
The infants will be recruited using fliers distributed at Starfish Therapies, an early 
intervention therapy provider in San Mateo, CA. Starfish therapies may give handouts to 
potential participants they identify through looking at their own clinic’s medical 
records or by looking at their own clinic logs. They are a pediatric clinic with 6 physical 
therapists, and see approximately 10 patients per week who meet our inclusion 
criteria. The caregivers will be asked to contact the research staff by phone or email for 
further information about the research study, including discussion of the exclusion 
criteria. When caregivers contact the research staff, the staff will give more specific 
information about the study and answer any questions. If the caregivers choose to 
participate after the initial contact, a written consent form will be provided to them. This 
will allow them to discuss their participation with others before signing the written 
consent. A parental consent form will be signed by a parent or legal guardian at the first 
visit, before any study procedures occur.  
  
Procedures: Visits will take place at Starfish Therapies and last approximately 30 
minutes.  
  
At the first visit (week 0), the researcher will measure the participant’s weight, overall 
development, and motor development. The researcher will assess and quantify motor 
development by administering the Alberta Infant Motor Scale, a standardized, norm-
referenced observational scale of motor development (5). The researchers will assess 
and quantify overall development using the Ages and Stages Questionnaire, 

a standardized, norm-referenced caregiver-report scale of development (6). This is 
standard of care.  
   
At the second visit, after a 4-week baseline period (week 4), the researcher will measure 
the participant’s weight and administer the Alberta Infant Motor Scale and the Ages and 
Stages 
Questionnaire. 
This 
is 
standard 
of 
care. 
The 
researcher 
will provide an Otteroo floatie to the family, along with an activity log to track it use. 
Caregivers will report date of use, duration of use, activities performed, and child’s 
response. The researcher will refer the family to the Otteroo website for some ideas of 
potential activities, as well as discuss and determine potential activities with the family. 
The researcher and family will use the Canadian Occupational Performance Measure (7), 
a standardized method for setting an individual goal, to set a goal relating 
to Otteroo use. The researcher will document therapy services received, and briefly 
describe the amount and type of any therapy received. This is for research purposes.  
  
After 4 weeks of Otteroo use (week 8), the researcher will collect the Alberta Infant Motor 
Scale, the Ages and Stages Questionnaire (all standard of care), and the Canadian 
Occupational Performance Measure (research purposes). The researcher will collect the 
activity 
log (research 
purposes). The 
researcher 
will 
document therapy 
services received, and briefly describe the amount and type of any therapy 
received (research purposes). The family will answer survey questions about their 
experience with Otteroo (research purposes). The family will keep the Otteroo floatie.  
  
After 4 weeks of reversal/retention period (week 12), the researcher will administer the 
Alberta Infant Motor Scale and the Ages and Stages Questionnaire. This is standard of 
care.  
  
Data Analysis. We will calculate descriptive statistics (mean, range, coefficient of 
variation) for all measures and describe the participants over time. The Alberta Infant 
Motor Scale is the primary outcome. We will relate the participant’s performance at each 
time point to norm-referenced results for their age. We will compare rate of change of 
Alberta Infant Motor Scale between weeks 0 and 4, 4 and 8, and 8 and 12. The 
Canadian Occupational Performance Measure is a secondary outcome measure, and we 
will report whether or not goals are met between weeks 4 and 8.  
  
Potential risks  
The infant or young child may become distressed during data collection or Otteroo use. 
The caregiver may stop any activity at any time and soothe the infant or child.  
  
There is a small risk that the Otteroo will deflate while the child is using it (due to leaks or 
seams breaking), and being in water carries risk of drowning. The caregiver must directly 
supervise and be within arm’s reach of the child while he or she uses the floatie. If it starts 
to deflate, the caregiver has been instructed in the consent form to stop using it and re-
inflate it before resuming use. If it deflates again, we will replace it.  
  
Protections  

Loss of confidentiality will be minimized by identifying all research data with the 
participant's study identification number, and allowing only those authorized to have 
access to the data. REDCap, a university supported, secure data collection and storage 
site will be used for collecting and storing the participant's randomly generated study 
identification code number and identifying information and health information. All other 
files will be identified by code numbers only, not by name or by any other information 
which might identify the parent or participant. All data will be on secured, password 
protected, backed up USC servers at all times.    
  
References  
  
1. 
Thelen E, Fisher DM. Newborn stepping: An explanation for a“ disappearing” reflex. 
Developmental Psychology. 1982;18(5):760.   
2. 
Kamm K, Thelen E, Jensen JL. A dynamical systems approach to motor 
development. Phys Ther. 1990 Dec;70(12):763–75.   
3. 
McManus BM, Kotelchuck M. The Effect of Aquatic Therapy on Functional Mobility 
of Infants and Toddlers in Early Intervention. Pediatric Physical Therapy. 
2007;19(4):275–82.   
4. 
Vignochi CM, Teixeira PP, Nader SS. Effect of aquatic physical therapy on pain 
and state of sleep and wakefulness among stable preterm newborns in neonatal 
intensive care units. Rev Bras Fisioter. 2010 May;14(3):214–20.   
5. 
Piper MC, Darrah J. Motor Assessment of the Developing Infant. Philadelphia, PA: 
WB Saunders; 1994.   
6. 
Squires J, Twombly E, Bricker DD, Potter L. Ages and Stages Questionnaires 
User's Guide. Brookes Publishing Company; 2009. 1 p.   
7. 
Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian 
Occupational Performance Measure: a research and clinical literature review. Can 
J Occup Ther. 2004 Oct;71(4):210–22.