Меню
Набор скоро начнётся NCT07136649

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

Без фазы С лечением Foot Deformities Orthotic Device 3D Printing CAD

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Custom CAD/CAM Insoles.
Кому может быть актуально
Состояния в реестре: Foot Deformities, Orthotic Device, 3D Printing, CAD. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effects of Custom CAD/CAM Insoles on Plantar Pressure Distribution in Individuals With Foot Deformities: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • Maximum Plantar Pressure [Срок оценки: Baseline and 8 weeks after intervention.]
  • Mean Plantar Pressure [Срок оценки: Baseline and 8 weeks after intervention.]
  • Plantar Contact Area [Срок оценки: Baseline and 8 weeks after intervention.]
  • Center of Pressure (COP) Displacement [Срок оценки: Baseline and 8 weeks after intervention.]
Вторичные конечные точки (4)
  • Step Length [Срок оценки: Baseline and 8 weeks after intervention]
  • Step Time [Срок оценки: Baseline and 8 weeks after intervention]
  • Walking Speed [Срок оценки: Baseline and 8 weeks after intervention.]
  • Regional Pressure Distribution [Срок оценки: Baseline and 8 weeks after intervention.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07136649 · assoc.prof.basarozturk

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗