Botulinum Toxin A Does Not Improve Cast Treatment for Idiopathic Toe-walking- a Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Percentage of toe-walking
研究概览
简要总结
The purpose of this study is to determine whether botulinum toxin A (BTX) adds a favourable effect to treatment of idiopathic toe-walking with below knee walking casts. The specific hypothesis to be tested is that a combination of BTX and casting is more effective than casting treatment alone in reducing toe-walking in 5-15 year old children. Evaluation methods include 3-D gait analysis, parents' perception of toe-walking frequency, passive joint range of motion measurements, and strength of ankle dorsal extension.
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
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with idiopathic toe-walking
- •5-15 years of age
排除标准
- •Previous treatment for idiopathic toe-walking, such as, Achilles tendon surgery, casting, orthotics, and BTX treatment.
- •Flexion contracture beyond -10 degrees in the ankle
研究组 & 干预措施
Group 2
Children treated with four weeks of below knee walking casts and botulinum toxin A injections
干预措施: Botulinum toxin A (Drug)
Group 1
Children treated with four weeks of below knee walking casts.
干预措施: Botulinum toxin A (Drug)
结局指标
主要结局
Percentage of toe-walking
时间窗: baseline, 3month, 12 month
次要结局
- Joint range of movement(Baseline, 3 month, 12 month)
- Classification of idiopathic toe-walking(Baseline, 3 month, 12 month)
- Gait analysis parameters(Baseline, 3 month, 12 month)
研究者
Pahr Engstrom
Principal Investigator
Karolinska Institutet