Customized Orthosis for Children With Clubfoot Following Ponseti Casting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Assessing Treatment Factors that Impact Brace Compliance with Parental Questionnaires
研究概览
简要总结
This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mitchell shoe during bracing, following Ponseti casting. The investigators hypothesize that following Ponseti casting, the implementation of customized AFOs with Ponseti bracing will improve patient compliance and functional outcomes as well as lead to fewer relapses in comparison to the standard bracing with Mitchell shoes.
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
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 12 months old (no age minimum)
- •no neuromuscular disease involved
- •treated by Ponseti casting
- •idiopathic bilateral or unilateral clubfoot
- •no other congenital foot deformity
- •no previous open surgeries to treat the deformity
排除标准
- •patients with prior surgical treatment
- •not treated by Ponseti casting
- •an underlying syndrome
- •neurological disorder
结局指标
主要结局
Assessing Treatment Factors that Impact Brace Compliance with Parental Questionnaires
时间窗: 24 weeks (from start of bracing treatment)
Assessing reasons for poor compliance with parental questionnaires. The questionnaires ask questions about casting, occurrences of skin lesions, history of treatments, bracing information, reasons for not using brace, and brace slippage
Time Spent in Brace to Assess Brace Compliance
时间窗: 24 weeks (from start of bracing treatment)
Measured with sensor placed in Mitchell shoe
Assessment of Functional Outcomes of Bracing Treatment Using Dimeglio Scores
时间窗: Collected when visit where cast is applied, visit when cast is removed, then at 2 weeks, 12 weeks, 24 weeks of bracing
Assessed using changes in Dimeglio Scores. The Dimeglio scoring system uses a 20-point system (20 being the most severe and \<5 as benign) by assessing four parameters. The severity of the deformity is then assigned a grade of I-IV with IV being the most severe. (A score of \<5 is given a grade of I, =5\<10 is grade II, =10\<15 is grade III, and =15\<20 is grade IV)
次要结局
- Assessing Demographic Factors that Impact Brace Compliance with Parental Questionnaire(24 weeks (from start of bracing treatment))
研究者
Scott Van Valin
Assistant Professor
Medical College of Wisconsin