Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
The Effect of Custom 3D Printed Insoles and Short Foot Exercises on Foot Posture, Balance, and Gait Parameters in Individuals With Pes Planus
The primary purpose of this study is to evaluate the effects of combining custom 3D-printed medial arch-supported insoles with short foot exercises on foot posture, balance, and gait parameters in individuals with pes planus (flat feet). Furthermore, the study will investigate the impact of this combined intervention on secondary outcomes, including pain levels, health-related quality of life, and functional exercise capacity measured by the 6-Minute Walk Test.
研究概览
详细说明
Participants will be recruited through personal networks and social media platforms using a snowball sampling method. Potential candidates will be screened for pes planus in accordance with established literature protocols, utilizing the Foot Posture Index-6 (FPI-6) and the Navicular Drop Test.
Eligible individuals who meet the criteria for pes planus will undergo 3D foot scanning. Based on the obtained data, customized medial arch-supported insoles will be manufactured using 3D printing technology. Participants will be instructed to use these custom insoles in their daily lives for a total of 8 weeks. Concurrently, they will be assigned a daily short foot exercise (intrinsic muscle training) program. Each exercise repetition will involve a 5-second hold, and the entire protocol will be maintained for 8 weeks.
All clinical, functional, and biomechanical evaluations-including foot posture, dynamic balance, comprehensive gait and plantar pressure analysis (via the Zebris system), pain intensity, quality of life, and functional walking capacity-will be conducted at two time points: at baseline and at the end of the 8-week intervention period.
For statistical analysis, depending on the normality of data distribution, either a paired t-test or a Wilcoxon signed-rank test will be used to evaluate within-group changes between baseline and week 8. To determine the magnitude of the intervention effect, Cohen's d effect sizes for dependent measures will be calculated and reported alongside 95% confidence intervals.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ayse Kocak Sezgin, Phd
- 电话号码：+90 5072243706
- 邮箱：ayse.kocaksezgin@ksbu.edu.tr
研究联系人备份
- 姓名：Emrah Afsar, Phd
- 电话号码：5062527008
- 邮箱：emrah.afsar@ksbu.edu.tr
学习地点
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Kütahya、土耳其（türkiye）
- 招聘中
- Kutahya Health Science University
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接触：
- Emrah Afsar, Phd
- 电话号码：5062527008
- 邮箱：emrah.afsar@ksbu.edu.tr
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首席研究员：
- Emrah Afsar, Phd
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副研究员：
- Zeynep Sena Namaz, MSc
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged between 18 and 35 years.
- Presence of pes planus, defined as a Navicular Drop test value > 10 mm and a Foot Posture Index-6 (FPI-6) score between +6 and +12.
- Willingness to volunteer for the study and provide written informed consent.
Exclusion Criteria:
- Presence of rigid pes planus.
- Hallux valgus.
- Hallux rigidus.
- Calcaneal spur (heel spur).
- History of any neurological, cardiovascular, or systemic diseases.
- History of any orthopedic disease affecting the lower extremities.
- History of lower extremity surgery.
- Body Mass Index (BMI) ≥ 30 kg/m².
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Insole and Exercise Group
All participants in this group will receive custom 3D printed insoles and perform a short foot exercise program. |
The intervention consists of a combined biomechanical and active rehabilitation approach for individuals with pes planus:
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Foot Posture Index-6 (FPI-6)
大体时间：Baseline and 8 Weeks
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Assesses foot posture across 6 criteria. Total scores range from -12 (highly supinated) to +12 (highly pronated). |
Baseline and 8 Weeks
|
|
Navicular Drop Test (NDT)
大体时间：Baseline and 8 Weeks
|
Assesses medial longitudinal arch height difference (in mm) between seated (non-weight bearing) and standing (weight bearing) positions. Higher values indicate increased pronation. |
Baseline and 8 Weeks
|
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Modified Star Excursion Balance Test (MSEBT)
大体时间：Baseline and 8 Weeks
|
Evaluates dynamic balance by measuring the maximum reach distance (in cm) in three directions: anterior, posteromedial, and posterolateral. |
Baseline and 8 Weeks
|
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Spatiotemporal Gait and Plantar Pressure Parameters
大体时间：Baseline and 8 Weeks
|
Evaluated using the Zebris system. Includes gait speed (m/s), cadence (steps/min), stride length (cm), stance percentage (%), and plantar pressure parameters (e.g., peak pressure, contact area). |
Baseline and 8 Weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
大体时间：Baseline and 8 Weeks
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Assesses pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). |
Baseline and 8 Weeks
|
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36-Item Short Form Health Survey (SF-36)
大体时间：Baseline and 8 Weeks
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Assesses health-related quality of life across 8 domains. Subscale scores are transformed to a 0 to 100 scale, where higher scores indicate better health status. |
Baseline and 8 Weeks
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6-Minute Walk Test (6MWT) and Modified Borg Scale
大体时间：Baseline and 8 Weeks
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Evaluates functional capacity by measuring the total distance walked in 6 minutes (in meters). Perceived exertion is assessed before and after the test using the Modified Borg Scale (0-10 scale; higher scores indicate greater exertion). |
Baseline and 8 Weeks
|
合作者和调查者
调查人员
- 首席研究员：Emrah Afsar, Phd、Kutahya Health Science University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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