Ireland
--:--IST
Recruiting Not applicable

Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus

NCT07895602 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-10-26
Last updated
2026-11-05

Condition(s) studied

Pes Planus

Investigational drug(s) / intervention(s)

Custom 3D Printed Insoles and Short Foot Exercises

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
35 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Foot Posture Index-6 (FPI-6) — Baseline and 8 Weeks
    Assesses foot posture across 6 criteria. Total scores range from -12 (highly supinated) to +12 (highly pronated).
  • Navicular Drop Test (NDT) — 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.
  • Modified Star Excursion Balance Test (MSEBT) — Baseline and 8 Weeks
    Evaluates dynamic balance by measuring the maximum reach distance (in cm) in three directions: anterior, posteromedial, and posterolateral.
  • Spatiotemporal Gait and Plantar Pressure Parameters — 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).

Trial sites (1)

FacilityCityRegionStatus
Kutahya Health Science University Kütahya Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07895602 on ClinicalTrials.gov ↗ ← All trials in Turkey