NCT01367340Unknown不适用
Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Gross Motor Function Measure
研究概览
简要总结
The purpose of this study is to investigate the effects of a 6-month physical activity intervention program on mobility and participation after the termination of a 6-week functional strengthening program for school-age children with spastic diplegia cerebral palsy. The primary outcomes are gross motor function, participation, and physical activity behavior.
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
- 5 Years 至 13 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with spastic diplegia, aged 6 to 12 year-old, and Gross Motor Function Classification System (GMFCS) level between I to III
- •able to stand up from a chair independently and maintain standing for more than 2 seconds without falling
- •able to answer questionnaire designed for school-age children
- •able to follow verbal instructions
排除标准
- •have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months
- •have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious LE joint contractures, uncontrolled epilepsy, or cardiopulmonary problems
- •hearing loss or using hearing aid
研究组 & 干预措施
Exercise and physical activity
Experimental
干预措施: Loaded sit-to-stand resistance exercise (Behavioral)
Exercise and physical activity
Experimental
干预措施: Physical activity intervention (Behavioral)
Exercise only
Active Comparator
干预措施: Loaded sit-to-stand resistance exercise (Behavioral)
结局指标
主要结局
Gross Motor Function Measure
时间窗: 1.5 months
次要结局
- One-repetition maximum of loaded sit-to-stand(1.5 months)
- Gait speed(Week 0, 6, 12, 18, 24, 36, 42, 48, 72)
- 1-minute walk test(1.5 months)
- School Function Assessment(3 months)
- Pediatric Evaluation of Disability Inventory(1.5 months)
- Physical activity status by International Physical Activity Questionnaire and accelerometer(3 months)
研究者
研究点 (1)
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