Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in 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
- 40
- 试验地点
- 1
- 主要终点
- Assisting Hand Assesment
研究概览
简要总结
Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.
In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.
详细描述
Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.
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
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of unilateral cerebral palsy
- •able to activate wrist and finger extensors
- •being scheduled for BoNT-A treatment for upper limb
排除标准
- •significant loss of wrist and or fingers
- •history of orthopedic surgery to plegic upper limb
研究组 & 干预措施
İntensive Therapy Group
Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT
干预措施: Botulinum toxin type A (Drug)
İntensive Therapy Group
Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT
干预措施: transcranial direct current stimulation (Device)
İntensive Therapy Group
Children who received Botulinum toxin type A to plegic upper limb would be treated by transcranial direct current stimulation and a hybrid training model of CIMT and BIT
干预措施: hybrid training model of CIMT and BIT (Other)
Control Group
Children who received Botulinum toxin type A to plegic upper limb would continue their usual care
干预措施: Botulinum toxin type A (Drug)
Control Group
Children who received Botulinum toxin type A to plegic upper limb would continue their usual care
干预措施: usual care (Other)
结局指标
主要结局
Assisting Hand Assesment
时间窗: 6 weeks
Bilateral Hand Function Evaluation Instrument
次要结局
- Jebsen Taylor Hand Function Test(6 weeks)
研究者
Nigar Dursun
Professor, MD
Kocaeli University