Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral palsy_AFO-Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- gait profile score (GPS)
研究概览
简要总结
Cerebral palsy (CP) in children and adolescents is frequently accompanied by gait abnormalities. Ankle-foot orthoses (AFO) have been suggested to improve the gait pattern. Compared to conventional AFO, modular AFO offer the opportunity to tune its response to the patient's gait characteristics and/or functional maturity. However, the evidence level is still small and AFO tuning is not yet established in clinical routine. The study will investigate individual tuning of custom-built ankle-foot-orthoses (AFO) using gait analyses
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order: To determine the order, the 4 conditions will be noted on a piece of paper and randomly picked from an envelope.
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in outpatient treatment from the University Children's Hospital Basel (UKBB)
- •Informed Consent provided as documented by signature
- •Confirmed diagnosis of cerebral palsy
- •Confirmed diagnosis of spastic equinus and/ or drop foot,
- •Gait pathologies treated with conventional AFO
- •Gross Motor Function Classification System (GMFCS) level I or II
排除标准
- •Other neuromuscular diseases
- •Previous surgical treatment to improve gait pathologies
- •Injections of Botulinum toxin 6 month prior to study inclusion
- •Inability or unwillingness to follow the procedures of the gait analysis
结局指标
主要结局
gait profile score (GPS)
时间窗: at end of study, an average of 1 month
overall score calculated from all kinematic parameters (joint rotation angles) of the affected leg and expressed as the deviation from the normal gait cycle in degrees. The mean GPS was anticipated to be 9° with standard deviation of 1.4° \[2\]. A good (r = 0.5) correlation of GPS for the within-subjects comparison was assumed. The non-inferiority margin was set at the minimally clinically important difference of 1.6°.
次要结局
- spatio-temporal parameter(at end of study, an average of 1 month)
- Movement analysis profile (MAP)(at end of study, an average of 1 month)