Custom CAD/CAM Insoles for Plantar Pressure Improvement in Foot Deformities
NCT ID: NCT07136649
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-09-01
2025-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Custom CAD/CAM Insole Group
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.
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.
Control Group (No Insole Intervention)
Participants in this group will not receive any insole intervention during the eight-week study period and will continue using their usual footwear.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Fenerbahce University
OTHER
Responsible Party
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Başar Öztürk
Associate Professor, Department of Physiotherapy and Rehabilitation (English), Faculty of Health Sciences, Fenerbahçe University
Central Contacts
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Other Identifiers
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assoc.prof.basarozturk
Identifier Type: -
Identifier Source: org_study_id
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