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临床试验/NCT03344952
NCT03344952已完成不适用

Long Term Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by an Integrated Approach of Repeated Botulinum Toxin-A Injections

Kocaeli University1 个研究点 分布在 1 个国家目标入组 503 人开始时间: 2017年11月20日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
503
试验地点
1
主要终点
Gross Motor Functional Classification System (GMFCS)

研究概览

简要总结

The aim of this retrospective, monocenter, observational study is to evaluate the changes in GMFCS levels of children with cerebral palsy (CP) who received repeated Botulinum Toxin-A (BoNT-A) injections in the lower limb(s) with an integrated treatment approach in Kocaeli University Department of PMR and Izmit Rehabilitation Center.

详细描述

It is generally agreed that children with CP reach their gross motor potential by the age of 3.5-5 and a child or young person over the age of 5 years will not improve their GMFCS level. BoNT-A is an important treatment in children with CP because it is safe in young children and allows combined treatment. The reduction in muscle tone by this selective treatment provides an opportunity to allow and optimize the effects of other treatments including orthoses, casting, conventional therapies and activity based functional trainings. For this reason, BoNT-A injections are always combined with other therapies in Kocaeli University Department of PMR and Izmit Rehabilitation Center. Adjunctive treatments in this department consists of serial casting, orthotics, physical therapy, occupational therapy, cognitive rehabilitation, special educational programs, non invasive brain stimulation with transcranial direct current, neurofeedback, biofeedback, electrical stimulation and other physical therapy modalities, activity based models including functional ambulatory training, constraint induced therapy, bilateral therapy, hippotherapy, music therapy by singing or playing percussive instruments or moving and dancing to music, and robotic rehabilitation. Individualized intensive combined treatment plan was applied by an appropriate neurorehab team to each patient within the department as a half day or full day program usually for 3 weeks starting 1 week or 10 days after BONT-A injections. In thıs retrospective, monocenter, observational study a software database program will be developed and all the present data about the demographic and clinic properties of the patients, all information about BoNT-A injections including safety and applied adjunctive treatments will be entered and reviewed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All children with a diagnosis of cerebral palsy with respect to Rosenbaum criteria
  • Children who received at least 2 repeated BoNT-A injections to lower limb(s) as well as an integrated treatment approach (an intensive therapy protocol consisted of a half day or entire day program in Kocaeli University Department of PMR and Izmit Rehabilitation Center) within the last 10 years

排除标准

  • Children who did not receive repeated injections
  • Children who did not receive an intensive therapy protocol

结局指标

主要结局

Gross Motor Functional Classification System (GMFCS)

时间窗: 10 years

Motor development

次要结局

  • Angle of catch (XV3) of Modified Tardieu Scale (MTS)(Before and 4-6 weeks after each injection)
  • Modified Ashworth Scale (MAS)(Before and 4-6 weeks after each injection)
  • Observational Gait Scale (OGS)(Before and 4-6 weeks after each injection)

研究者

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

Nigar Dursun

Professor, MD

Kocaeli University

研究点 (1)

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