Investigation of the Effects of Custom-Designed 3D-Printed and CAD-CAM-Produced Insoles in Individuals With Flexible Pes Planus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Foot Function Index (FFI) Score
研究概览
简要总结
This study aims to investigate the effects of custom-designed insoles produced using Computer Numerical Control (CNC) and 3D printers on plantar pressure distribution analysis, foot posture, plantar force distribution, foot pain, and satisfaction in patients diagnosed with pes planus.
详细描述
This randomized controlled trial evaluates the impact of custom-designed insoles, created using Computer Numerical Control (CNC) and 3D printing technologies, on plantar pressure distribution, foot posture, pain, and user satisfaction in individuals with flexible pes planus. The study targets adults aged 18-55, with specific clinical and postural inclusion criteria, and excludes individuals with biomechanical or neurological confounders.
Participants are randomly assigned to one of two intervention groups using a simple randomization method: one receiving CNC-produced insoles and the other 3D-printed insoles. Assessments are conducted before and after 8 weeks of insole use, employing standardized tools such as the Foot Posture Index, subtalar angle measurement, plantar pressure analysis, and satisfaction/function questionnaires. The primary aim is to explore comparative biomechanical and subjective outcomes to inform best practices in orthotic design and application.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged between 18 and 55 years
- •Diagnosed with flexible pes planus (flat feet)
- •No prior use of custom orthotic insoles within the past 6 months
- •Able to walk independently without assistive devices
- •Voluntarily agree to participate and provide informed consent
排除标准
- •History of lower limb or foot surgery
- •Presence of neurological, rheumatologic, or musculoskeletal disorders affecting gait
- •Presence of severe foot deformities (e.g., rigid pes planus, cavus foot)
- •Use of medications that affect muscle or joint function
- •Pregnancy
结局指标
主要结局
Change in Foot Function Index (FFI) Score
时间窗: Baseline and 8 weeks after intervention
This measure assesses changes in foot pain, disability, and activity limitation using the Foot Function Index (FFI). Participants complete the FFI questionnaire before and after the intervention period. The score ranges from 0 to 100, with higher scores indicating worse foot function.
次要结局
未报告次要终点
研究者
GÖZDE KESİKBAŞ
Orthotic Prosthetist
Lokman Hekim Üniversitesi