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临床试验/NCT04997044
NCT04997044已完成不适用

A Randomized Controlled Study Investigating the Effect of Designed Physical Training After Selective Dorsal Rhizotomy on Motor Function of Ambulant Children With Spastic Diplegia

Cairo University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Functional Balance

研究概览

简要总结

The management of cerebral palsy is complex and requires a multidisciplinary approach. Selective dorsal rhizotomy is a neurosurgical technique that aims to reduce spasticity in the lower limbs and improve motor function.

详细描述

the current study is designed to assess the effectiveness of Selective dorsal rhizotomy on motor function in ambulant children with spastic diplegia. therefore, A convenient sample of ambulant children with spastic diplegia will be allocated to two groups of equal numbers (control and experimental)

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •CP, spastic diplegia
  • •4-8 years of age
  • •The ability to walk with or without assistive devices typically on Level II-III on Gross Motor Function Classification System
  • •At least six months after the last Botulinum toxin A injection in the lower extremities
  • •Average intelligent quotient according to medical records for active participation
  • •Good trunk control with good antigravity strength of lower extremity on clinical examination.
  • •Exclusionary criteria
  • •Ankle clonus; exaggerated deep tendon reflex in the legs
  • •Babinski sign
  • •Structural non-reducible deformities or musculoskeletal surgery in the lower extremities in the past 12 months
  • •Moderate to severe signs of dystonia, athetosis or ataxia.

排除标准

  • 未提供

研究组 & 干预措施

control group

Other

control group

干预措施: Concomitant physical rehabilitation (Other)

control group

Other

control group

干预措施: Standard Orthotic Management (Other)

Experimental group

Experimental

selective dorsal rhizotomy group

干预措施: Concomitant physical rehabilitation (Other)

Experimental group

Experimental

selective dorsal rhizotomy group

干预措施: Standard Orthotic Management (Other)

Experimental group

Experimental

selective dorsal rhizotomy group

干预措施: selective dorsal rhizotomy (Other)

结局指标

主要结局

Functional Balance

时间窗: after 6 months and after 1 year (follow-up)

The pediatric balance scale was used to assess the child's functional performance with total score is 56 and higher score representing a better performance.

Gross motor function

时间窗: after 6 months and after 1 year (follow-up)

The gross motor function measure-88 is used to evaluate the motor function with total score is 100 and higher scores representing a better performance.

次要结局

  • Functional capacity(after 6 months and after 1 year (follow-up))
  • Selective voluntary motor control(after 6 months and after 1 year (follow-up))
  • Energy cost of walking(after 6 months and after 1 year (follow-up))

研究者

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

Amira Mahmoud Abd-elmonem

Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Cairo University

研究点 (1)

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