跳至主要内容
临床试验/NCT01367340
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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年8月1日最近更新:
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

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验