A Randomized Controlled Trial on Integrated Management of Pronation Deformity of Children With Cerebral Palsy Treated by Botulinum Toxin-A
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Mean change from baseline Modified Ashworth Scale (MAS)
研究概览
简要总结
Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .
详细描述
Spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. Pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. There is very limited information about how to treat this deformity in the current literature.
In this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having pronation deformity.
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
- Single (Investigator)
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
- 否
入选标准
- •Diagnosis of cerebral palsy
- •MAS score of pronator muscles at least 2
- •Gross Motor Functional Classification Scale level of I-IV
- •Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles
排除标准
- •Severe cognitive or behavioural problems
- •Less than 40 degrees of available passive range of motion in pronation
- •Severe dystonia in the affected upper limb
- •Received orthopedic surgery to affected upper limb
研究组 & 干预措施
Experimental Group
Patients treated by Botulinum toxin A and twister and specific home exercise program
干预措施: Home exercise program (Other)
Experimental Group
Patients treated by Botulinum toxin A and twister and specific home exercise program
干预措施: Botulinum toxin type A (Drug)
Experimental Group
Patients treated by Botulinum toxin A and twister and specific home exercise program
干预措施: Upper extremity orthoses (Other)
Conventional Therapy Group
Patients treated by Botulinum toxin A and specific home exercise program
干预措施: Botulinum toxin type A (Drug)
Conventional Therapy Group
Patients treated by Botulinum toxin A and specific home exercise program
干预措施: Home exercise program (Other)
结局指标
主要结局
Mean change from baseline Modified Ashworth Scale (MAS)
时间窗: Week 12
Tone measurement
次要结局
- Mean change from baseline passive range of supination(Week 12)
- Mean change from baseline angle of catch (XV3) Tardieu scale(Week 12)
- Mean change from baseline active range of supination(Week 12)
研究者
Nigar Dursun
Professor
Kocaeli University