NCT01357954已完成不适用
The Efficacy of Targeted Training on the Postural Control and Gross Motor Function 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
- 28
- 试验地点
- 2
- 主要终点
- Change from baseline in Gross Motor Function Measure at 6 months
研究概览
简要总结
The project aims to test the effectiveness and explore the possibility of performing a novel therapeutic approach, targeting to increase strength and coordination around the trunk, giving a more active and functional seating and head control in those children with cerebral palsy (CP) who are wheelchair users. The project will also try to determine the muscle physiological effect of treatment using indirect measures of strength in the spinal musculature.
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
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of CP made by a neuro-pediatric physician experienced in assessment and diagnosis of CP
- •GMFCS level III, IV and V,
- •the child cannot walk without assistance,
- •age 2-15 year,
- •no joint deformity or contracture around the "Targeted" joint
- •not a candidate for surgery or other medical treatment that affects motor skills while participating in the project
- •trunk control problems.
排除标准
- •uncontrolled epilepsy
- •surgery within 12 months of the study start
- •Botulinum toxin within 2 months of study start
- •Lack of personnel resources to treat the child at their school/kindergarten
结局指标
主要结局
Change from baseline in Gross Motor Function Measure at 6 months
时间窗: Baseline, 6 months
次要结局
- Change from baseline in seated sway at 6 months(Baseline, 6 months)
- Degree of achievement of a goal set at baseline using a modified Goal Attainment Scale (GAS)(12 months)
- Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 12 months(Baseline, 12 months)
- Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 6 months(Baseline, 6 months)
- Change from baseline in Gross Motor Function Measure at 12 months(Baseline, 12 months)
- Change from baseline in Pediatric Evaluation of Disability Inventory (PEDI)at 6 months(Baseline, 6 months)
- Change from baseline in seated sway at 12 months(Baseline, 12 months)
- Change from baseline in thickness of the erector spinae muscles measured with ultrasound at 12 months(Baseline, 12 months)
研究者
Derek Curtis
Research Physiotherapist, Hvidovre University Hospital.
Hvidovre University Hospital
研究点 (2)
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