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临床试验/NCT07338162
NCT07338162已完成不适用

Is Serial Casting a Valid Option for Management of Lower Limb Deformities in Patient With Spastic Cerebral Palsy (Equinus - Equinovarus)?

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月1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
40
试验地点
1
主要终点
Evaluation of ankle range of motion

研究概览

简要总结

This study aimed to evaluate the effectiveness of serial casting as a modality of management of lower limb deformities in patients with spastic cerebral palsy (equinous - equinovarus).

详细描述

Cerebral Palsy (CP) is classified as a group of postural and motor disorders caused by a non-progressive lesion to the developing brain, acquired before the age of two. Among the different types of CP, spastic CP is the most common form consisting of approximately 85.8% of diagnoses.

Current clinical management of spasticity and contracture in the lower limb includes conservative approaches such as the use of physiotherapy, orthoses, casting and splinting. Other commonly used invasive strategies for spasticity and contracture management include neurotoxin injections such as botulinum toxin A (BTX-A) and intrathecal baclofen, as well as surgery such as selective dorsal rhizotomy (SDR) and various corrective orthopaedic operations including tendon lengthening procedures and single-event multilevel surgeries (SEMLS).

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
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients from 3 to 12 years old.
  • Both sex.
  • Spastic cerebral palsy patients with true equinous.
  • Modified Ashworth Scale score of 2 or 3 in the plantar flexor muscle complex.
  • Gross Motor Functional Classification System Level I, II & III.

排除标准

  • Patients with bony joint limitation.
  • Previous surgeries (tendon lengthening).
  • Patients received Botulinum toxin A injections in the last six months.
  • Patients with apparent equinus as a compensation for knee or hip flexion while dorsiflexion range is preserved at the lower extremity.

研究组 & 干预措施

Group A

Active Comparator

Children with spastic cerebral palsy who is subjected to a selected physical therapy program once a day/3 times a week for three successive weeks mainly consisted of stretching and strengthening exercises, weight bearing, balance, proprioception, and ambulation training.

干预措施: Physical therapy program (Other)

Group B

Experimental

Children with spastic cerebral palsy who is additionally subjected to three consecutive casts applied for five days each and will be removed in the last two days in each week to conduct the same selected physical therapy program.

干预措施: Three consecutive casts + Physical therapy program (Other)

结局指标

主要结局

Evaluation of ankle range of motion

时间窗: 3 months after the procedure

Ankle range of motion was assessed.

次要结局

  • Tone of the calf muscle(3 months after the procedure)
  • Detection of ankle kinematics during gait(3 months after the procedure)
  • Incidence of true equinous in patients with spastic cerebral palsy(3 months after the procedure)
  • Modified Ashworth Scale (MAS) score(3 months after the procedure)

研究者

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

Ahmed Mohamed Abdou Mohamed Dawood

Orthopaedic Surgery specialist at Al-Helal Hospital, Egypt.

Cairo University

研究点 (1)

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