Effects of Repeated Botulinum Toxin Injections in Lower Extremity Muscles on Muscle Morphology and Functionality in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Muscle morphology
研究概览
简要总结
One of the disorders observed in children with cerebral palsy (CP) is abnormal muscle tone, and the most common tone problem is spasticity. Botulinum toxin A (BoNT-A) injections are frequently used to reduce spasticity in CP rehabilitation. BoNT-A injections can be administered as a single dose, and some patients require repeated injections. The aim of this study was to examine the effects of repeated BoNT-A applications applied to the gastrocnemius muscle of children with CP on muscle morphology and functionality.
详细描述
The study will be planned to include 50 children with CP. The children will be divided into two groups.Children who had been injected once or twice before were included in one group; children who received 3 or more injections were included in the other group.Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle) was evaluated by ultrasonography, muscle stiffness was evaluated by shear wave ultrasound elastography, and muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist. Functionality of children with CP was evaluated with gross motor function measure (GMFM), time up go test, squat test and vertical jumping tests by an experienced pediatric physiotherapist.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years
- •Children who had previously been injected with BoNT-A into the gastrocnemius muscle
排除标准
- •Children with dyskinetic, ataxic, and hypotonic type CP
- •Children with a history of any surgical operation or botulinum toxin injection treatment in the previous 6 months
结局指标
主要结局
Muscle morphology
时间窗: Through study completion, an average of 1 year
Gastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist.
Functionality 1
时间窗: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was Gross Motor Funtion Mesaurement (GMFM) by an experienced pediatric physiotherapist.
Functionality 4
时间窗: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was vertical jumping test by an experienced pediatric physiotherapist.
Functionality 3
时间窗: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was squat test by an experienced pediatric physiotherapist.
Muscle stiffness
时间窗: Through study completion, an average of 1 year
Muscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist.
Muscle vascularization
时间窗: Through study completion, an average of 1 year
Muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist.
Functionality 2
时间窗: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was time up go test by an experienced pediatric physiotherapist.
次要结局
未报告次要终点
研究者
Kamile Uzun Akkaya
Principal Investigator
Gazi University