Treatment of Idiopathic Clubfoot Utilizing Botulinum Toxin A: A New Treatment for Correction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The rate of successful clubfoot correction from a single Botox injection. This coincides with entrance into Boots and Bars. This was measured 8 weeks following injection.
研究概览
简要总结
The purpose of this study was to determine the efficacy of adding Botox injection to serial manipulations and castings in patients with clubfoot. The study hypothesis was that the use of Botox in the setting of serial manipulations and castings is an effective treatment for clubfoot.
详细描述
All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children presenting with idiopathic clubfoot/feet at BC Children's Hospital
- •Children ranging in age from 1 day to 2 years old at initial treatment Children who have had previous intervention for their clubfoot (methods including surgery, Ponseti method, Kite method, physical therapy method) and had a clubfoot recurrence requiring re-intervention
排除标准
- 未提供
结局指标
主要结局
The rate of successful clubfoot correction from a single Botox injection. This coincides with entrance into Boots and Bars. This was measured 8 weeks following injection.
时间窗: 8 weeks
次要结局
- 1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit)(See protocol)
- Secondary outcomes of the study as outlined in protocol (include time of measurement)(See protocol)
- Secondary Outcomes: Patient outcomes collected at every patient visit including:(See protocol)
- 2. Heel Bisector Scores (collected at every visit)(See protocol)
- 3. Pedobarographs (every 6 months from 18 months to 5 years)(See protocol)
- Gait Analysis (every 2 years from 5 years of age until skeletal maturity)(See protocol)
研究者
Christine Alvarez
Principle Investigator
University of British Columbia