Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by Repeated Botulinum Toxin-A
2018年11月29日 更新者：Nigar Dursun、Kocaeli University
Long Term Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by an Integrated Approach of Repeated Botulinum Toxin-A Injections
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
503
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kocaeli、火鸡、41050
- Kocaeli University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
All children diagnosis of cerebral palsy with respect to Rosenbaum criteria having 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
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Children who did not receive repeated injections
- Children who did not receive an intensive therapy protocol
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：追溯
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Gross Motor Functional Classification System (GMFCS)
大体时间：10 years
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Motor development
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10 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Modified Ashworth Scale (MAS)
大体时间：Before and 4-6 weeks after each injection
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Assessment of tone
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Before and 4-6 weeks after each injection
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Angle of catch (XV3) of Modified Tardieu Scale (MTS)
大体时间：Before and 4-6 weeks after each injection
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Assessment of spasticity
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Before and 4-6 weeks after each injection
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Observational Gait Scale (OGS)
大体时间：Before and 4-6 weeks after each injection
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OGS is a measurement tool for analysis of gait consisting of seven gait parameters with a total score of 20.
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Before and 4-6 weeks after each injection
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月20日
初级完成 (实际的)
2018年10月10日
研究完成 (实际的)
2018年11月9日
研究注册日期
首次提交
2017年11月14日
首先提交符合 QC 标准的
2017年11月14日
首次发布 (实际的)
2017年11月17日
研究记录更新
最后更新发布 (实际的)
2018年11月30日
上次提交的符合 QC 标准的更新
2018年11月29日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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