Effects of Custom-Designed 3D-Printed and CAD-CAM Insoles on Individuals With Flexible Flatfoot

NCT07022093 | Completed

• 1 other identifier: 2024211
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pes Planus

Keywords

pes planus; 3D insoles; custom made insoles

Outcome Measures

Primary Outcomes (1)

• Change in Foot Function Index (FFI) Score

  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.

  Baseline and 8 weeks after intervention

Study Arms (2)

Custom insoles manufactured using CNC technology

ACTIVE COMPARATOR

Customised insoles will be produced using CNC technology and delivered based on the analyses of 20 patients with pes planus.

Device: Custom made insoles

Custom insoles produced using 3D technology

ACTIVE COMPARATOR

Custom insoles produced using 3D technology will be delivered to 20 patients with pes planus.

Device: Custom made insoles

Interventions

Custom made insoles DEVICE

For the production of insoles using the CAD-CAM method; In the production of insoles, medial longitudinal arch support will be added so that the subtalar joints are in a neutral position, and additionally, transverse arch support between 3.5-5 mm, lateral longitudinal arch support between 4-6 mm, and finger-under supports to assist with palmar grip will be designed in three dimensions using the EasyCad modelling interface. Using a Vulcan Computer Numerical Control (CNC) milling machine, the insoles will be machined from Ethylene Vinyl Acetate (EVA) material placed in blocks. After this process, the insoles will be adjusted on the milling machine to fit the patient's shoes.For the production of insoles using the 3D printing method, the Elegoo Neptune 4 Max 3D printer will be used. Using TPU material, medial longitudinal arch support will be added, along with transverse arch support between 3.5-5 mm, lateral longitudinal arch support between 4-6 mm, and finger support to aid palmar grip.

Also known as: Insoles

Custom insoles manufactured using CNC technology; Custom insoles produced using 3D technology

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GÖZDE KESİKBAŞ: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35882078 BACKGROUND

• 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).

  BACKGROUND

MeSH Terms

Conditions

Flatfoot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Nilgün Bek, PhD

  Lokman Hekim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthotic Prosthetist

Model Details: Participants are allocated to two parallel groups for intervention and control, evaluated over the same study duration.

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: June 15, 2025
• Study Start: October 9, 2024
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

TU (1)