ISRCTN69541857已完成未知
Effect of botulinum toxin A injections and specific intensive rehabilitation therapy in children with hemiparetic cerebral palsy on upper limb functions and skills
Ipsen Biopharm Ltd (UK)0 个研究点目标入组 60 人开始时间: 2008年3月31日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 2.5 - 12 years, either sex
- •2. Cerebral palsy
- •3. Hagberg diagnosis: spastic hemiparesis or extreme asymmetric diplegia
- •4. Hand function impairment Zancolli grade I with evident problems in thumb extension and supination, Zancolli grade IIA and IIB
- •5. Mentally able to comprehend and perform tasks
- •6. Children and their parents should be able to cope with the intensive rehabilitation therapy programme and the measurement sessions
- •7. Children and the parents/caregivers should comprehend and speak Dutch
- •8. Children and their parents indicate the necessity for improvement of the children's abilities
排除标准
- •1. Severe structural contractures of the muscles at the extremity to be treated:
- •1.1. Passive elbow extension maximum 160 degrees or less
- •1.2. Supination maximum 30 degrees or less from neutral position
- •1.3. Wrist dorsal flexion maximum 20 degrees or less in children aged 2.5 - 6 years, or 45 degrees or less in age group 7 - 12 years
- •2. Severe impairment of hand function: no active hand function is expected after treatment (Zancolli III)
- •3. Hand surgery or phenolisation or btA injections in the arm less than nine months ago
- •4. Contraindication for botulinum toxin (muscular diseases such as myasthenia gravis, tetanus vaccination less than three months before the injection, use of aminoglycoside antibiotics or spectinomycine and known hypersensitivity for human albumin)
- •5. Contraindication for anaesthesia
- •6. Children who cannot bear touching the affected arm and hand
研究者
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