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临床试验/NCT04256187
NCT04256187已完成不适用

Pros and Cons of Botulinum Injection Treatment in Cerebral Palsy: A Qualitative Study Examining the Caregiver's Perspectives

Marmara University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年11月1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
21
试验地点
1
主要终点
Experience of Botulinum toxin treatment

研究概览

简要总结

The aim of this study is to quantitatively record the opinions regarding the pros and cons of this treatment of the caregivers of children with cerebral palsy who had botulinum toxin applied in investigators' clinic.

详细描述

Spasticity is defined as an increase in physiological resistance of the muscles associated with a lack of supraspinal inhibition against passive strain. It is a common and prohibitive problem associated with an increase in tendon reflex and tension reflex associated with upper motor neuron dysfunction. One of the most common problems in patients with CP.

Methods used in the treatment of spasticity; medical therapy, physical therapy, intrathecal baclofen pump, botulinum toxin injection, and orthopedic correction operations. However, botulinum toxin type-A (BTX-A) injections, which are applied to the muscles especially for localized spasticity, have become an effective adjuvant option that increases the effectiveness of classical methods and diversifies the treatment options.

BTX-A, which is basically a chemodenervation method; It is a treatment method that blocks the transmission of signal in the neuromuscular junction by preventing the release of acetylcholine vesicles into the presynaptic space. In spastic muscles, relaxation can be achieved by correct injection. Botulinum toxin type A has been shown to be an effective and safe treatment for children to reduce spasticity.

In Turkish society, there is no study evaluating the caregivers' experiences and opinions about botox treatments of patients with the diagnosis of cerebral palsy and limited studies in the literature are from countries with different sociodemographic features such as the United States and the United Kingdom. Although these patients have been receiving this treatment in investigators' center for years, there is no study in the literature that evaluates the plus and minus aspects of caregivers' experiences in this regard.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be the caregiver of a patient under 18 years old with cerebral palsy
  • No attempt has been made to reduce spasticity such as botulinum toxin injection in the last 3 months.

排除标准

  • Not knowing Turkish
  • Refusing to participate in the study.

结局指标

主要结局

Experience of Botulinum toxin treatment

时间窗: Day 0

Qualitative interview performed at one occasion where the caregivers describes the experience about the their childrens' botulinum toxin treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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