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COMPLETED
NCT06563492
NA

The Effect of Insoles in Plantar Fasciitis

Sponsor: Medipol University

View on ClinicalTrials.gov

Summary

This randomized active-comparator clinical trial compared changes over 12 weeks between customized computer numerical control (CNC)-milled ethylene-vinyl acetate (EVA) and fused deposition modelling (FDM) 3D-printed thermoplastic polyurethane (TPU) insoles with plantar fasciitis. The primary outcome was bilateral gastrocnemius medialis and lateralis muscle activation recorded using surface electromyography during a standardized 10-meter walking task. Secondary outcomes included static plantar loading, pain, foot-related function, and user satisfaction. Because both groups received custom-made insoles as active interventions, the trial was designed to compare the two orthosis types rather than to determine the absolute efficacy of insoles.

Official title: Effects of Custom Made EVA and 3D-Printed TPU Insoles on Gastrocnemius Muscle Activation and Static Pedobarographic Parameters in Plantar Fasciitis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2024-12-16

Completion Date

2026-07-21

Last Updated

2026-08-31

Healthy Volunteers

No

Interventions

DEVICE

Custom-Made CNC-Milled EVA Insole

A custom-made insole was individually manufactured from ethylene-vinyl acetate (EVA) using computer numerical control (CNC) milling. Participants used the assigned insole for 12 weeks.

DEVICE

Custom-Made FDM 3D-Printed TPU Insole

A custom-made insole was individually manufactured from thermoplastic polyurethane (TPU) using fused deposition modelling (FDM) three-dimensional printing. Participants used the assigned insole for 12 weeks.

Locations (1)

Istanbul Medipol University, Prosthetics and Orthotics Center (POMER)

Beykoz, Istanbul, Turkey (Türkiye)