Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pediatric Evaluation of Disability Inventory
研究概览
简要总结
Self-produced locomotion often is limited in children with cerebral palsy and other conditions that cause severe motor impairments. As a result, these children may be at risk for secondary impairments in spatial cognition, communication, social development, and other domains influenced by independent mobility. To compensate, power mobility has increasingly been advocated for young children with severe motor impairments. The study hypotheses were:
- Children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility.
- Parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.
详细描述
More extensive description is not desired.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 to 30 months
- •Motor impairment that prevents functional independent mobility
- •Vision and hearing adequate to use a power mobility device safely.
- •Cognitive abilities assessed to be at least equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted.
排除标准
- 未提供
结局指标
主要结局
Pediatric Evaluation of Disability Inventory
时间窗: Baseline and 12 months
Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.
Battelle Developmental Inventory (BDI)
时间窗: Baseline and 12 months
Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.
Early Coping Inventory
时间窗: Baseline and 12 months
We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.
次要结局
未报告次要终点
研究者
Irene McEwen
Principal Investigator
University of Oklahoma