Infants With or at Risk/Concern for Developmental Delay
Conditions
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.
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.
Interventions
OTHEROtteroo
Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single subject research design case series
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 66 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alberta Infant Motor Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Otteroo: Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Otteroo Adjunct | — |
|---|---|---|
| Age, Continuous | 403 days STANDARD_DEVIATION 353 | — |
| Alberta Infant Motor Scale | 11 overall percentile score (range 0-100) | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 4 Participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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.
Time frame: weeks 0 and 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Otteroo Adjunct | Change in Alberta Infant Motor Scale | 5 change in percentile |