Combined Effect of Repetitive Transcranial Magnetic Stimulation and Botulinum Injection on Spasticity and Motor Functions of Children With Diplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- modified aswthor scale
研究概览
简要总结
This trial will enroll 75 children with spastic diplegic cerebral palsy both matched in age, sex, degree of disability and cognitive functions with the same exclusion criteria undergoing the same physical therapy. All enrolled children will undergo routine physical therapy program and will be divided into three groups (n = 25 per group) according treatment methods. Group A: children will be given local injections of botulinum toxin type ,Group B: children will be given repetitive transcranial magnetic stimulation on the affected side; Group C: children will be given local injections of botulinum toxin type A combined with repetitive transcranial magnetic stimulation , the three groups will take physical therapy (PT) of 45 minutes duration 4 days a week for 3 months .The grade of spasticity will be assessed by using Modified Ashworth scale and M/H ratio by using EMG. The grade of motor function will assessed by using Gross Motor Function Classification System (GMFCS).
详细描述
This trial will enrol 75 children with spastic diaplegic cerebral palsy with both sex, degree of disability and cognitive functions with the same exclusion criteria and the same physical therapy program. All enrolled children will undergo routine physical therapy program and will be divided into three groups (n = 25 per group) according treatment methods. Group A: children will be given local injections of botulinum toxin type ,Group B: children will be given repetitive transcranial magnetic stimulation on the affected side; Group C: children will be given local injections of botulinum toxin type A combined with repetitive transcranial magnetic stimulation , the three groups will take physical therapy (PT) of 45 minutes duration 4 days a week for 3 months.
They will diagnosed based on history taking including perinatal, developmental, and family history, general and neurological examination. The included children with clinical diagnosis of moderate spastic diplegic cerebral palsy with a MAS (1, 1+, 2) and GMFCS (II, III, IV) will participated in this study. On the contrary, children with dyskinetic CP, mental retardation, previous ankle or knee surgery, uncontrolled epileptic seizure or contracture will excluded
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
- None
入排标准
- 年龄范围
- 4 Years 至 4 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •were diagnosed based on history taking including perinatal, developmental, and family history, general and neurological examination.
- •The included children with clinical diagnosis of moderate spastic dialogic cerebral palsy with a MAS (1, 1+, 2) and GMFCS (II, III, IV) were participated in this study
排除标准
- •Children who's contraindicated to rTMS treatment have metal implants such as internal pacemakers and intracranial scaffolds, and/or a history of epilepsy.
- •Children who's Contraindicated for BTX-A treatment: hypersensitivity and local infection at the injection site.
- •Children which have received a local injection of BTX-A within 3 months.
- •Children with dyskinetic CP,
- •Mental retardation,
- •previous, seizure or contracture were excluded.
研究组 & 干预措施
Botox for spasticity
Botox for spasticity in lower limbs in cerebral palsy children
干预措施: botulinum toxin A (Drug)
Botox for spasticity
Botox for spasticity in lower limbs in cerebral palsy children
干预措施: Rehabilitation Training Protocol (Other)
transcranial magnetic stimulation for spasticity
transcranial magnetic stimulation for spasticity in cerebral palsy children
干预措施: Transcranial Magnetic Stimulation (Device)
transcranial magnetic stimulation for spasticity
transcranial magnetic stimulation for spasticity in cerebral palsy children
干预措施: Rehabilitation Training Protocol (Other)
Botox combined with transcranial magnetic stimulation for spasticity
Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children
干预措施: botulinum toxin A (Drug)
Botox combined with transcranial magnetic stimulation for spasticity
Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children
干预措施: Transcranial Magnetic Stimulation (Device)
Botox combined with transcranial magnetic stimulation for spasticity
Botox combined with transcranial magnetic stimulation for spasticity in cerebral palsy children
干预措施: Rehabilitation Training Protocol (Other)
结局指标
主要结局
modified aswthor scale
时间窗: 3 months
Modified Ashworth Scale (MAS): The MAS measures the resistance and spasticity in the joint during passive movement. The resistance is scored from 0 to 5 (0 the least severe to 5 the most severe
次要结局
- Gross Motor Function Classification System(3 months)
研究者
Rana Nabil Hussein Mohamed
lecturer of pediatric physical therapy
MTI University
