Effect of Botulinum Toxin Type A Associated With Physical Therapy on the Functional Capacity of Children With Spastic Cerebral Palsy: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Severity of muscle hypertonia
研究概览
简要总结
Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A) associated with physical therapy on the functional capacity of children with spastic cerebral palsy (CP). Material and methods: Twenty-four children with spastic CP were concealed and randomly assigned to the Experimental Group (EG) consisting of 12 patients treated with BoNT-A and physical therapy and Control with 12 patients treated only with physical therapy. All participants were assessed through motor and functional scales (GMFM-88, Ashworth, Berg Balance Scale, TUG test and Pediatric Evaluation of Disability Inventory) at three different times: before and after 30 days of treatment as well as 3 months after the end of treatment.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Evaluator 1: triage, random draw of treatments to be performed; Evaluator 2: BoNT-A application; Evaluator 3: assessment data collection; Evaluator 4: physical therapy treatment. Evaluator 3 was blinded in relation to the groups.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of spastic Cerebral Palsy
- •Clinical diagnosis of Dynamic equine feet
排除标准
- •Use of phenol in the last 12 months
- •Neurological blocks in the last 6 months
- •Clinical diagnosis of structured orthopedic deformities with surgical indications
研究组 & 干预措施
Experimental group (EG)
The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).
干预措施: Botulinum toxin type A (Drug)
Experimental group (EG)
The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).
干预措施: Physical Therapy (Other)
Control group (CG)
GC was treated with physiotherapy (stretching, balancing training, functional walking training).
干预措施: Physical Therapy (Other)
结局指标
主要结局
Severity of muscle hypertonia
时间窗: 3 months
The classification of hypertonia was performed by Modified Ashworth Scale
Functional balance
时间窗: 3 months
Functional balance was assessed using the Berg Balance Scale (BBS).
次要结局
- Functional mobility(3 months)
- Functional performance(3 months)
研究者
Fabiano Politti
Principal Investigator
University of Nove de Julho