Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Merrill-Palmer-Revised
研究概览
简要总结
The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development.
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
- •Must be between 14- and 30-months of age
- •Must have clinical diagnosis of a motor impairment that prevents functional independent mobility
- •Must have adequate vision and hearing to use power mobility device safely
- •Must have cognitive abilities 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
研究组 & 干预措施
Power mobility
Intervention included provision of power wheelchair and power mobility training program. Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.
干预措施: Power mobility (Other)
Control
Children in the control group will not receive any additional intervention, but will continue to receive the early intervention or other services they were receiving prior to enrollment in this study.
结局指标
主要结局
Merrill-Palmer-Revised
时间窗: Entry, 6-months, and 12-months
Pediatric Evaluation of Disability Inventory
时间窗: Entry, 6-months, 12-months
次要结局
- Child Health Status(Entry)
- Two-position object permanence test(Entry, 6 months, 12 months)
- Nonspeech Test(Entry, 6 month, 12 months)
- Home Observation Measure of the Environment(Entry, 6 months, 12 months)
- Parenting Stress Inventory(Entry, 6 months, 12 months)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Entry, 6 months, 12 months)
- Hollingshead Scale(Entry)