Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot

Официальное название

Does Correction of Pronated Foot Posture Alter Patellofemoral Alignment? A Weight-Bearing Cone Beam CT Proof-of-Concept Study in Individuals With Flexible Flatfoot

Обзор

This study will look at whether correcting a flat foot position with foot orthoses, also called shoe inserts, can change the position of the kneecap during standing. Some people with flexible flatfoot have a foot position that may affect how the lower leg and knee are aligned. This may influence the way the kneecap sits or tilts in relation to the thigh bone. Foot orthoses are often used for knee and foot problems, but it is not clear whether they directly change kneecap position when a person is standing and bearing weight. The study will include adults with flexible flatfoot. Each participant will have low-dose, three-dimensional weight-bearing cone beam CT scans while standing in different foot positions: their natural foot position, with foot orthoses, and with foot orthoses inside a neutral running shoe. Scans will be performed with the knees straight and slightly bent. The main hypothesis is that correcting a pronated flat foot position with foot orthoses will reduce sideways tilt and outward shift of the kneecap compared with the participant's natural foot position. The study will also examine whether changes in foot position are accompanied by changes in lower-limb rotation. This study does not test whether foot orthoses reduce pain. Instead, it is designed to understand the immediate mechanical effect of foot correction on kneecap position.

Вмешательства

• Устройство Foot Orthoses
  Standardized prefabricated foot orthoses will be used to correct a pronated foot posture toward neutral rearfoot alignment during weight-bearing. Three orthosis configurations will be available, differing in medial arch height and degree of lateral calcaneal tilt. For each participant, the orthosis that best achieves neutral rearfoot alignment will be selected. If forefoot varus prevents neutral rearfoot alignment, an additional medial forefoot wedge may be applied under the first metatarsal. T

Первичные конечные точки

• Change in Lateral Patellar Tilt [Срок оценки: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
• Change in Bisect Offset [Срок оценки: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]

Вторичные конечные точки (5)

• Change in Tibial Tuberosity-Trochlear Groove Distance [Срок оценки: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
• Change in Transmalleolar Rotation Across Foot Posture Conditions [Срок оценки: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
• Change in Tibial Rotation Across Foot Posture Conditions [Срок оценки: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
• Change in Femoral Rotation Across Foot Posture Conditions [Срок оценки: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]
• Change in Patellar Rotation Across Foot Posture Conditions [Срок оценки: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion]

Критерии участия

Критерии включения

• Age 18-35 years
• Pronated foot posture, defined as a Foot Posture Index (FPI) score of ≥ +6, including a calcaneal frontal plane position sub-score of +2. 25,26

○ A trained examiner will assess FPI; inclusion is based on the right foot.

• Flexible flatfoot deformity, defined as restoration of the medial longitudinal arch during lift of the first toe.

Критерии исключения

• Knee pain during standing or at 20° knee flexion
• Clinical signs of tibiofemoral instability
• Previous knee or foot surgery
• History of patellar dislocation
• Neuromuscular disease
• Pregnancy
• Inability to perform full weight bearing during scans

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Дания · 1 центр

• Sportsmedicinsk Center, Frederikshavn Sygehus — Frederikshavn

Идентификаторы

NCT: NCT07678840 · N-20260014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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