Custom CAD/CAM Insoles for Plantar Pressure Improvement in Foot Deformities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Custom CAD/CAM Insoles.
- Who it may be relevant to
- Registry conditions: Foot Deformities, Orthotic Device, 3D Printing, CAD. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Custom CAD/CAM Insoles on Plantar Pressure Distribution in Individuals With Foot Deformities: A Randomized Controlled Trial
Overview
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.
Detailed description
This randomized controlled trial will evaluate the impact of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with clinically diagnosed foot deformities. Thirty eligible participants, aged 18-65 years, will be randomly assigned to one of two groups:
Intervention Group: Participants will receive custom-designed CAD/CAM insoles based on 3D plantar scans and pedobarographic analysis.
Control Group: Participants will not receive insole intervention during the eight-week study period.
Baseline assessments will include demographic data, anthropometric foot measurements, and pedobarographic analysis using the As200 Gait Scan System. The intervention group will be instructed to use the custom insoles daily for eight consecutive weeks, while the control group will maintain their usual footwear without insoles.
After eight weeks, all participants will undergo the same measurement procedures. Primary outcome measures will include maximum and mean plantar pressures, contact area, and center of pressure displacement. Secondary outcomes will include step length, step time, walking speed, and regional pressure distribution across foot segments.
Data analysis will be conducted using repeated-measures statistical models to evaluate time × group effects, with significance set at p \< 0.05. The study will be conducted at the Kale Prosthetics and Orthotics Center between September and November 2025, following approval from the Fenerbahçe University Non-Interventional Clinical Research Ethics Committee.
Interventions
- Device Custom CAD/CAM Insoles
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.
Primary outcome measures
- Maximum Plantar Pressure [Time frame: Baseline and 8 weeks after intervention.]
- Mean Plantar Pressure [Time frame: Baseline and 8 weeks after intervention.]
- Plantar Contact Area [Time frame: Baseline and 8 weeks after intervention.]
- Center of Pressure (COP) Displacement [Time frame: Baseline and 8 weeks after intervention.]
Secondary outcome measures (4)
- Step Length [Time frame: Baseline and 8 weeks after intervention]
- Step Time [Time frame: Baseline and 8 weeks after intervention]
- Walking Speed [Time frame: Baseline and 8 weeks after intervention.]
- Regional Pressure Distribution [Time frame: Baseline and 8 weeks after intervention.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07136649 · assoc.prof.basarozturk