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临床试验/NCT01367327
NCT01367327已完成不适用

Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2009年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Gross Motor Function Measure

研究概览

简要总结

The purpose of study is to investigate the effects of PSE Music with a "home-based" loaded STS exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia.

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 SD, aged 5 to 13 year-old, and 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 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
  • •have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders

研究组 & 干预措施

Exercise with music

Experimental

Loaded sit-to-stand exercise with music for 6 weeks

干预措施: Loaded sit-to-stand exercise (Behavioral)

Exercise with music

Experimental

Loaded sit-to-stand exercise with music for 6 weeks

干预措施: Synchronized music (Behavioral)

Exercise without music

Active Comparator

Loaded sit-to-stand exercise without music for 6 weeks

干预措施: Loaded sit-to-stand exercise (Behavioral)

结局指标

主要结局

Gross Motor Function Measure

时间窗: 12 weeks

次要结局

  • Intrinsic Motivation Inventory-Chinese Version(12 weeks)
  • Exercise Adherence and Volume(12 weeks)
  • Motor Control Variables of the STS Movement(12 weeks)
  • Pediatric Evaluation of Disability Inventory(12 weeks)
  • One-repetition maximum of loaded sit-to-stand test(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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