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临床试验/NCT05312125
NCT05312125已完成不适用

Comparison of the Effectiveness of Different Physiotherapy and Rehabilitation Programs After Onabotulinum Toxin-A Injection and Serial Casting in Children With Cerebral Palsy

Gazi University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Muscle strenght

研究概览

简要总结

The effects of different physiotherapy programs on children with cerebral palsy who have been received botulinum toxin injection and serial casting application will be determined.

详细描述

CP children who underwent botulinum toxin injection to medial gastrocnemius muscle and serial casting application in last two months will be included in the study. The effects of traditional physiotherapy and downhill backward treadmill training plus to traditional physiotherapy on muscle morphology, activity, walking, quality of life and selectivity will be determined.

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
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with cerebral palsy (CP) (hemiplegic-diplegic)
  • To have undergone botulinum toxin and serial casting interventions in the last 2 months
  • to be between 5-10 years old
  • Being at the level of I-II-III (ambulatory or assisted ambulatory) according to Gross Motor Function Classification System
  • To have the mental competence to understand and apply assessments and exercises

排除标准

  • Having undergone surgery involving the lower extremity in the last 6 months
  • Refusing to participate in the study
  • Having other accompanying neurometabolic or orthopedic disorders

结局指标

主要结局

Muscle strenght

时间窗: After six weeks intervention

Will be measured by manual muscle tester

Muscle morphology

时间窗: After six weeks intervention

Muscle thickness, cross sectional area, fiber length, pennation angle will be recorded by ultrasonographic measurements

Vascularization

时间窗: After six weeks intervention

Muscle vascularization will be recorded by Suberb Microvascular Imaging (SMI) method via ultrasonographic measurements

Range of motion

时间窗: After six weeks intervention

Will be measured with goniometer

Modified Tardieu Scale

时间窗: After six weeks intervention

Lower extremity spasticity will be mesured with this scale. Higher scores mean more intensive spasticity

Edinburgh visual gait analysis

时间窗: After six weeks intervention

Gait will be recorded as video and this video will be scored

次要结局

  • Lower extremity selective control measurement(After six weeks intervention)
  • Child Health Questionnare (Parent form)(After six weeks intervention)
  • Children Functional Independence Measurement Scale(After six weeks intervention)
  • Demographic data(After six weeks intervention)

研究者

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

pelin atalan

Physiotherapist, MSc

Gazi University

研究点 (2)

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