NCT01815814已完成不适用
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in Gross Motor Function Measure Score
研究概览
简要总结
The investigators hypothesize that children with spastic cerebral palsy will show greater improvements in gross motor function, associated developmental skills and growth after the 3 months of myofascial structural integration treatment, a form of deep massage, than they showed after a 3- or 6-month pre-treatment waiting period.
The investigators further hypothesize that children with spastic CP will maintain their gains in gross motor function for ≥ 3 months after completion of MSI treatment.
详细描述
- The investigators will talk to you by telephone to determine if your child is eligible for the study.
- The study lasts for a total of 12 months with the massage treatment period lasting 12 weeks.
- The study entails a total of 10 sessions of Myofascial Structural Integration therapy over the 12-week period. Each session will last one hour.
- The child will have an evaluation of motor functions and development on enrollment and at three-month intervals for a total of 5 evaluations.
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
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 1 up to, but not including, 7 years of age
- •Children having the diagnosis of spastic cerebral palsy
- •Children who have spasticity in one or both upper or lower limbs
- •Children who are classified as either Gross Motor Function Classification System (GMFCS) level 2, 3 or 4 or Manual Ability Classification System (MACS) level 2, 3, 4 or 5
排除标准
- •Children with active seizure disorders
- •Children taking more than one medication to control their seizures
- •Children with severe health problems that could be exacerbated by the treatment (such as severe chronic lung disease)
- •Children who have undergone surgical treatments or botulinum injections within 6 months of entering the study
- •Children who have planned surgical interventions during the studies time course
- •Children with sensory, cognitive or language deficits which would affect their ability to understand directions necessary for assessment.
结局指标
主要结局
Change in Gross Motor Function Measure Score
时间窗: at Enrollment and every 3 months thereafter for up to 12 months
次要结局
- Change in GAITRite Mat Measures(at Enrollment and every 3 months thereafter for up to 12 months)
研究者
Heidi M. Feldman
Ballinger-Swindells Professor of Developmental and Behavioral Pediatrics
Stanford University
研究点 (2)
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