Clinical Effectiveness of the Modified WalkFlex DB Splint in Children With Congenital Talipes Equinovarus (CTEV): A Prospective Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pirani Score
研究概览
简要总结
This pilot study aims to evaluate the effectiveness of the Modified WalkFlex DB Splint in the maintenance phase of Congenital Talipes Equinovarus (CTEV) treatment following successful correction through the Ponseti method. The traditional Denis Browne splint, though widely used, often limits patient mobility and can result in poor compliance. In response to these limitations, the Modified WalkFlex DB Splint was designed to offer increased flexibility at the knee and hip joints, allowing for improved function and easier ambulation while maintaining foot correction.
详细描述
This is a prospective observational study including 12-15 children aged between 3 months to 3 years who have completed the casting phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 3 months to 3 years diagnosed with idiopathic congenital talipes equinovarus (CTEV)
- •who have completed the correction phase using the Ponseti method and are starting the bracing phase.
- •Informed consent from parents or guardians and willingness to attend follow-ups at 1 and 3 months is required
排除标准
- •Children with non-idiopathic clubfoot (e.g., syndromic or neuromuscular)
- •other congenital limb deformities
- •or poor compliance with treatment and follow-up will be excluded
结局指标
主要结局
Pirani Score
时间窗: 12 Months
Used to assess the severity of clubfoot deformity. It consists of six clinical signs divided into midfoot and hindfoot scores. Each sign is scored as 0 (normal), 0.5 (moderate), or 1 (severe). The total score ranges from 0 (normal foot) to 6 (severe deformity).
Relapse Assessment Checklist (Clinical Observation)
时间窗: 12 Months
Observation-based checklist used at 1-month and 3-month follow-ups to check for signs of relapse such as equinus, varus, adductus, or cavus. Relapse is defined as the recurrence of one or more of these deformities after initial correction.
Parental/Guardian Feedback Questionnaire (Custom/Adapted)
时间窗: 12 Months
A structured feedback form to assess splint tolerance, ease of use, and parental satisfaction. Responses are collected using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree) on questions regarding comfort, usability, and perceived effectiveness of the splint.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University