Clinical trial NCT07022093: Effects of Custom-Designed 3D-Printed and CAD-CAM Insoles on Individuals With Flexible Flatfoot
Official title: Investigation of the Effects of Custom-Designed 3D-Printed and CAD-CAM-Produced Insoles in Individuals With Flexible Pes Planus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pes Planus
Keywords: pes planus
3D insoles
custom made insoles
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2025-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are allocated to two parallel groups for intervention and control, evaluated over the same study duration.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Foot Function Index (FFI) Score
timeFrame: Baseline and 8 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Lokman Hekim Üniversitesi
name: Nilgün Bek, PhD
role: STUDY_DIRECTOR
References:
citation: Daryabor A, Kobayashi T, Saeedi H, Lyons SM, Maeda N, Naimi SS. Effect of 3D printed insoles for people with flatfeet: A systematic review. Assist Technol. 2023 Mar 4;35(2):169-179. doi: 10.1080/10400435.2022.2105438. Epub 2022 Aug 24.
citation: Yarwindran, M., Sa'aban, N. A., Ibrahim, M., & Periyasamy, R. (2016). Thermoplastic elastomer infill pattern impact on mechanical properties 3D printed customized orthotic insole. ARPN J. Eng. Appl. Sci, 11(7).