Custom CAD/CAM Insoles for Plantar Pressure Improvement in Foot Deformities
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFenerbahce University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Custom CAD/CAM Insoles
DeviceCustom 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Custom CAD/CAM Insole GroupExperimental treatment 1 intervention
Group B: Control Group (No Insole Intervention)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Maximum Plantar Pressure
Maximum plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Time frame
Baseline and 8 weeks after intervention.2
Mean Plantar Pressure
Mean plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Time frame
Baseline and 8 weeks after intervention.3
Plantar Contact Area
Plantar contact area (cm²) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Time frame
Baseline and 8 weeks after intervention.4
Center of Pressure (COP) Displacement
Center of pressure (COP) displacement (mm) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Time frame
Baseline and 8 weeks after intervention.Secondary outcomes
1
Step Length
Step length (cm) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Time frame
Baseline and 8 weeks after intervention2
Step Time
Step time (ms) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Time frame
Baseline and 8 weeks after intervention3
Walking Speed
Walking speed (m/s) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Time frame
Baseline and 8 weeks after intervention.4
Regional Pressure Distribution
Plantar pressure distribution by foot regions (kPa) assessed using the As200 Gait Scan Pedobarography System.
Time frame
Baseline and 8 weeks after intervention.Other outcomes
1
Arch Height
Arch height (cm) measured using a digital caliper and measuring tape.
Time frame
Baseline and 8 weeks after intervention.2
Navicular Drop
Navicular drop (mm) measured using a digital caliper and measuring tape.
Time frame
Baseline and 8 weeks after intervention.3
Hallux Valgus Angle
Hallux valgus angle (degrees) measured using a goniometer.
Time frame
Baseline and 8 weeks after intervention.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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