Custom CAD/CAM Insoles for Plantar Pressure Improvement in Foot Deformities

NCT07136649 | Not Yet Recruiting

• 1 other identifier: assoc.prof.basarozturk
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial will investigate the effects of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with foot deformities, such as pes planus, pes cavus, and hallux valgus. A total of 30 participants will be randomly assigned to either the intervention group, receiving custom CAD/CAM insoles, or the control group, receiving no insole intervention. Plantar pressure measurements will be performed using the As200 Gait Scan Pedobarography System at baseline and after eight weeks. Static and dynamic plantar pressure variables, contact area, and center of pressure displacement will be assessed, along with gait parameters including step length, step time, and walking speed. The results of this study may contribute to the development of effective conservative treatment strategies to improve foot biomechanics and reduce pressure-related complications in individuals with foot deformities.

Conditions

Foot Deformities; Orthotic Device; 3D Printing; CAD

Keywords

Custom CAD/CAM Insoles; Pes Planus; Pes Planovalgus; Pes Cavus; Pedobarography; Plantar Pressure; 3D Printing; Orthotics

Outcome Measures

Primary Outcomes (4)

• Maximum Plantar Pressure

  Maximum plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.

  Baseline and 8 weeks after intervention.

• Mean Plantar Pressure

  Mean plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.

  Baseline and 8 weeks after intervention.

• Plantar Contact Area

  Plantar contact area (cm²) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.

  Baseline and 8 weeks after intervention.

• Center of Pressure (COP) Displacement

  Center of pressure (COP) displacement (mm) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.

  Baseline and 8 weeks after intervention.

Secondary Outcomes (4)

• Step Length

  Baseline and 8 weeks after intervention

• Step Time

  Baseline and 8 weeks after intervention

• Walking Speed

  Baseline and 8 weeks after intervention.

• Regional Pressure Distribution

  Baseline and 8 weeks after intervention.

Other Outcomes (3)

• Arch Height

  Baseline and 8 weeks after intervention.

• Navicular Drop

  Baseline and 8 weeks after intervention.

• Hallux Valgus Angle

  Baseline and 8 weeks after intervention.

Study Arms (2)

Custom CAD/CAM Insole Group

EXPERIMENTAL

Participants in this group will receive custom CAD/CAM insoles designed based on 3D plantar scans and pedobarographic analysis. The insoles will be fitted into their regular footwear and used daily for eight consecutive weeks.

Device: Custom CAD/CAM Insoles

Control Group (No Insole Intervention)

NO INTERVENTION

Participants in this group will not receive any insole intervention during the eight-week study period and will continue using their usual footwear.

Interventions

Custom CAD/CAM Insoles DEVICE

Custom insoles will be designed using 3D plantar scanning and pedobarographic analysis, produced with CAD/CAM technology. The insoles will be fitted into participants' regular footwear and worn daily for eight consecutive weeks. The design aims to optimize plantar pressure distribution and improve foot biomechanics in individuals with foot deformities.

Custom CAD/CAM Insole Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• Clinically diagnosed with a foot deformity (e.g., pes planus, pes cavus, hallux valgus)
• Able to use custom insoles for at least six months
• Able to stand and walk for pedobarographic measurements
• Willing to participate and provide informed consent

You may not qualify if:

• Presence of neurological or systemic diseases affecting foot function (e.g., diabetic neuropathy)
• History of lower extremity surgery in the last six months
• Severe musculoskeletal conditions impairing sensorimotor function
• Any condition preventing compliance with insole use
• Contraindications for participating in gait or pressure measurements

Sponsors & Collaborators

• Fenerbahce University: lead

MeSH Terms

Conditions

Foot Deformities; Flatfoot; Clubfoot; Talipes Cavus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

BAŞAR ÖZTÜRK, Assoc. Prof.

CONTACT

+905370150630; basar.ozturk@fbu.edu.tr

Baha Naci, PhD

CONTACT

+905364664390; baha.naci@fbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to group allocation to prevent measurement bias during data collection and analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Physiotherapy and Rehabilitation (English), Faculty of Health Sciences, Fenerbahçe University

Model Details: Participants will be randomly assigned to either the intervention group, receiving custom CAD/CAM insoles, or the control group, receiving no insole intervention, with both groups assessed at baseline and after eight weeks.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share