An interventional study of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus, sponsored by Kutahya Health Sciences University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Treatment
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.
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.
171 studies on the registry are indexed under Flatfoot; 42 are open to participants now.
This study's planned enrollment of 54 is above the median of 37 across 124 interventional studies indexed under Flatfoot.
Browse Flatfoot studies →Kutahya Health Sciences University is the lead sponsor of 216 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
All participants in this group will receive custom 3D printed insoles and perform a short foot exercise program.
Other: Custom 3D Printed Insoles and Short Foot Exercises
The intervention consists of a combined biomechanical and active rehabilitation approach for individuals with pes planus: 1. Custom 3D Printed Insoles: The participants' feet will be 3D scanned, and custom insoles will be manufactured using 3D printing technology. Participants will be recommended to use these personalized insoles during their daily activities for a total of 8 weeks. 2. Short Foot Exercises (SFE): Participants will perform a short foot exercise (foot core / intrinsic muscle) program aimed at increasing intrinsic foot muscle activation. The exercise protocol will be performed daily for 8 weeks, with each repetition held for five seconds.
Foot Posture Index-6 (FPI-6)
Assesses foot posture across 6 criteria. Total scores range from -12 (highly supinated) to +12 (highly pronated).
Time frame: Baseline and 8 Weeks
Navicular Drop Test (NDT)
Assesses medial longitudinal arch height difference (in mm) between seated (non-weight bearing) and standing (weight bearing) positions. Higher values indicate increased pronation.
Time frame: Baseline and 8 Weeks
Modified Star Excursion Balance Test (MSEBT)
Evaluates dynamic balance by measuring the maximum reach distance (in cm) in three directions: anterior, posteromedial, and posterolateral.
Time frame: Baseline and 8 Weeks
Spatiotemporal Gait and Plantar Pressure Parameters
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).
Time frame: Baseline and 8 Weeks
Numeric Pain Rating Scale (NPRS)
Assesses pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline and 8 Weeks
36-Item Short Form Health Survey (SF-36)
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.
Time frame: Baseline and 8 Weeks
6-Minute Walk Test (6MWT) and Modified Borg Scale
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).
Time frame: Baseline and 8 Weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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