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临床试验/NCT06218316
NCT06218316Enrolling By Invitation不适用

Combined Effect of Repetitive Transcranial Magnetic Stimulation and Botulinum Injection on Spasticity and Motor Functions of Children With Diplegic Cerebral Palsy

MTI University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年10月15日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Botox for spasticity in lower limbs in cerebral palsy children

干预措施: botulinum toxin A (Drug)

Botox for spasticity

Experimental

Botox for spasticity in lower limbs in cerebral palsy children

干预措施: Rehabilitation Training Protocol (Other)

transcranial magnetic stimulation for spasticity

Experimental

transcranial magnetic stimulation for spasticity in cerebral palsy children

干预措施: Transcranial Magnetic Stimulation (Device)

transcranial magnetic stimulation for spasticity

Experimental

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

Experimental

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana Nabil Hussein Mohamed

lecturer of pediatric physical therapy

MTI University

研究点 (1)

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