Exploring Otteroo Use In Early Intervention: A Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Alberta Infant Motor Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Weeks 至 66 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pre-locomotor (able to locomote independently less than 4 feet)
- •a healthcare provider or caregiver has identified concerns about potential developmental delay
排除标准
- •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
结局指标
主要结局
Change in Alberta Infant Motor Scale
时间窗: 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.
次要结局
未报告次要终点
研究者
Beth A. Smith
Assistant Professor
University of Southern California