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

27 июля 2026 г. обновлено: Regionshospital Nordjylland

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

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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

10

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Mads K Hilligsøe, Doctor
  • Номер телефона: +4542210433
  • Электронная почта: m.hilligsoee@rn.dk

Места учебы

  • Дания
      • Frederikshavn, Дания, 9900
        • Sportsmedicinsk Center, Frederikshavn Sygehus
        • Контакт:
          • Mads K Hilligsøe, Doctor
          • Номер телефона: +4542210433
          • Электронная почта: m.hilligsoee@rn.dk

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Фундаментальная наука
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Foot Posture Conditions

Participants will undergo standardized weight-bearing cone beam CT scans under three foot posture conditions: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a standardized neutral running shoe. Each condition will be assessed with the knees fully extended and at 20 degrees of knee flexion.

The foot orthosis will be selected for each participant to correct the rearfoot toward neutral alignment. If needed, an additional forefoot wedge may be used to achieve neutral alignment. The same orthotic correction will be maintained across the relevant scan conditions.
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. The selected orthotic configuration, including any forefoot wedge, will be kept unchanged during the relevant scan conditions. The intervention will be tested both barefoot and inside a standardized neutral running shoe.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Lateral Patellar Tilt
Временное ограничение: 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
Lateral patellar tilt will be measured in degrees on standardized weight-bearing cone beam CT images. The measure describes the sideways tilt of the kneecap in relation to the thigh bone. It is defined as the angle between the transverse axis of the patella and the posterior condylar axis of the femur. Measurements will be performed for each foot posture condition: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a neutral running shoe. Measurements will be assessed at both 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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
Временное ограничение: 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
Bisect offset will be measured as a percentage on standardized weight-bearing cone beam CT images. The measure describes the sideways position of the kneecap in relation to the groove of the thigh bone. It is defined as the percentage of lateral displacement of the midpoint of the patella from the midpoint of the trochlear groove. Higher percentages indicate greater lateral displacement of the kneecap. Measurements will be performed for each foot posture condition: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a neutral running shoe. Measurements will be assessed at both 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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 показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Tibial Tuberosity-Trochlear Groove Distance
Временное ограничение: 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
Tibial tuberosity-trochlear groove distance will be measured on standardized weight-bearing cone beam CT images and reported in millimeters. The measure describes the side-to-side distance between the tibial tuberosity, where the patellar tendon attaches on the shin bone, and the center of the trochlear groove of the thigh bone, where the kneecap moves. Measurements will be performed for each foot posture condition: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a neutral running shoe. Measurements will be assessed at both 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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
Временное ограничение: 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
Transmalleolar rotation will be measured in degrees on standardized weight-bearing cone beam CT images. The measure describes the rotation of the ankle axis in relation to the long axis of the foot. The ankle axis is defined as a line through the medial and lateral malleoli. The foot axis is defined by an adjusted sagittal foot reference plane derived from calcaneal and metatarsal head landmarks on cone beam CT. Transmalleolar rotation is calculated as the angle between the malleolar line and this foot axis. Positive values indicate external rotation relative to the foot axis, and negative values indicate internal rotation. Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion.
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
Временное ограничение: 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
Tibial rotation will be measured in degrees on standardized weight-bearing cone beam CT images. The measure describes the rotation of the shin bone in relation to the long axis of the foot. It is defined as the angle between a line tangent to the posterior surface of the proximal tibia and the foot axial rotation reference. The foot axial rotation reference is an adjusted sagittal foot plane derived from calcaneal and metatarsal head landmarks on cone beam CT. Positive values indicate external rotation relative to the foot axis, and negative values indicate internal rotation. Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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
Временное ограничение: 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
Femoral rotation will be measured in degrees on standardized weight-bearing cone beam CT images. The measure describes the rotation of the thigh bone in relation to the long axis of the foot. It is defined as the angle between a line tangent to the posterior femoral condyles and the foot axial rotation reference. The foot axial rotation reference is an adjusted sagittal foot plane derived from calcaneal and metatarsal head landmarks on cone beam CT. Positive values indicate external rotation relative to the foot axis, and negative values indicate internal rotation. Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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
Временное ограничение: 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
Patellar rotation will be measured in degrees on standardized weight-bearing cone beam CT images. The measure describes the rotation of the kneecap in relation to the long axis of the foot. It is defined as the angle between the transverse axis of the patella and the foot axial rotation reference. The foot axial rotation reference is an adjusted sagittal foot plane derived from calcaneal and metatarsal head landmarks on cone beam CT. Positive values indicate external rotation relative to the foot axis, and negative values indicate internal rotation. Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Navicular Plantar Position Across Foot Posture Conditions
Временное ограничение: 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
Navicular plantar position will be measured in millimeters on standardized weight-bearing cone beam CT images. The measure describes the vertical position of the navicular bone, which is a bone on the inner side of the midfoot and an indicator of medial arch position. It is defined as the perpendicular distance between the lowest point of the navicular bone and the tripod-adjusted axial foot plane. This reference plane is based on the plantar support points of the foot. Greater values indicate that the navicular bone is positioned farther from the plantar reference plane. Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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 Navicular Medial Displacement Across Foot Posture Conditions
Временное ограничение: 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.
Navicular medial displacement will be measured in millimeters on standardized weight-bearing cone beam CT images. The measure describes the side-to-side position of the navicular bone, which is a bone on the inner side of the midfoot and an indicator of foot pronation and medial arch position. It is defined as the perpendicular distance from the most medial point of the navicular bone to the adjusted sagittal foot reference plane. This reference plane is derived from calcaneal and metatarsal head landmarks on cone beam CT and approximates the long axis of the foot. Greater values indicate that the navicular bone is positioned farther medially relative to the foot reference plane. Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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 Foot Axial Rotation Across Foot Posture Conditions
Временное ограничение: 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
Foot axial rotation will be measured in degrees on standardized weight-bearing cone beam CT images. The measure describes the toe-in or toe-out orientation of the foot. It is defined as the angle between the adjusted sagittal foot reference plane and the global sagittal plane. The adjusted sagittal foot reference plane is derived from calcaneal and metatarsal head landmarks and approximates the long axis of the foot. Positive values indicate external rotation, or toe-out, and negative values indicate internal rotation, or toe-in. Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion. Change will be reported as the within-participant difference between foot posture conditions.
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
Baseline Femoral Anteversion
Временное ограничение: Baseline, during the first weight-bearing cone beam CT scan
Femoral anteversion will be measured in degrees on the baseline weight-bearing cone beam CT scan. The measure describes the forward rotation of the femoral neck in relation to the distal femur. It is defined as the angle between the femoral neck axis and the posterior condylar axis of the distal femur. The femoral neck axis is defined as a line connecting the center of the femoral head and the center of the femoral neck. The posterior condylar axis is defined as a line tangential to the most posterior aspects of the medial and lateral femoral condyles. Positive values indicate increased femoral anteversion. This measure will be used to describe baseline femoral morphology and to account for anatomical variation that may influence lower-limb rotational alignment.
Baseline, during the first weight-bearing cone beam CT scan
Baseline Foot Posture Index
Временное ограничение: Baseline, during the screening assessment before the imaging visit
Foot Posture Index will be assessed at baseline by a trained examiner during standing. The measure describes the participant's static foot posture, including the degree of pronation or supination. The Foot Posture Index is a clinical scoring tool with six items, each scored from -2 to +2, giving a total score from -12 to +12. Lower scores indicate a more supinated foot posture, and higher scores indicate a more pronated foot posture. In this study, baseline pronated foot posture is defined as a Foot Posture Index score of +6 or higher, including a calcaneal frontal-plane position sub-score of +2. Inclusion is based on the right foot.
Baseline, during the screening assessment before the imaging visit
Baseline Calcaneal Frontal-Plane Angle
Временное ограничение: Baseline, during standing assessment before foot posture correction
Calcaneal frontal-plane angle will be measured in degrees at baseline during standing. The measure describes the frontal-plane position of the heel bone in relation to the lower leg and reflects the degree of rearfoot valgus or varus. It is defined as the angle between a posterior calcaneal bisection line and a vertical tibial reference line. The posterior calcaneal bisection line is established using markers on the proximal and distal thirds of the posterior calcaneus. The tibial reference line is defined by the vertical midline of the distal third of the tibia. If used in the dataset coding, positive values will indicate calcaneal valgus and negative values will indicate calcaneal varus.
Baseline, during standing assessment before foot posture correction
Age
Временное ограничение: At inclusion
At inclusion
BMI
Временное ограничение: At inclusion
At inclusion
Sex
Временное ограничение: At inclusion
At inclusion
Perceived Comfort of the Selected Foot Orthosis Assessed by a 10-Point Numeric Rating Scale
Временное ограничение: Immediately after completion of the imaging protocol during the imaging visit
Perceived comfort of the selected foot orthosis will be assessed immediately after completion of the imaging protocol using a 10-point numeric rating scale. Participants will be asked to rate how comfortable the selected foot orthosis felt during the scan conditions. The scale ranges from 1 to 10, where 1 indicates "not comfortable at all" and 10 indicates "maximally comfortable." Higher scores indicate greater perceived comfort of the orthosis.
Immediately after completion of the imaging protocol during the imaging visit
Baseline Patellar Height Assessed by Patellar Articular Overlap
Временное ограничение: Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
Patellar height will be assessed at baseline using patellar articular overlap on weight-bearing cone beam CT images. Patellar articular overlap describes the proportion of the kneecap joint surface that overlaps with, or is positioned within, the trochlear groove of the thigh bone. It will be expressed as a percentage. Higher percentages indicate greater overlap between the patellar articular surface and the trochlear groove, while lower percentages indicate less overlap. This measure will be used to describe baseline patellofemoral morphology and alignment.
Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
Baseline Lateral Trochlear Inclination
Временное ограничение: Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
Lateral trochlear inclination will be measured in degrees on the baseline weight-bearing cone beam CT scan. The measure describes the slope of the outer part of the trochlear groove, which is the groove of the thigh bone where the kneecap moves. It is defined as the angle of the lateral trochlear facet in relation to the posterior condylar line of the femur. This measure will be used to describe baseline trochlear morphology and patellofemoral anatomy.
Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
Baseline Sulcus Angle
Временное ограничение: Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
Sulcus angle will be measured in degrees on the baseline weight-bearing cone beam CT scan. The measure describes the shape and depth of the trochlear groove, which is the groove of the thigh bone where the kneecap moves. It is defined as the angle formed by three points: the highest point of the medial trochlear facet, the deepest point of the trochlear groove, and the highest point of the lateral trochlear facet. A larger sulcus angle generally indicates a flatter or shallower trochlear groove, while a smaller angle indicates a deeper groove. This measure will be used to describe baseline trochlear morphology and patellofemoral anatomy.
Baseline, during the first weight-bearing cone beam CT scan before foot posture correction

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Regionshospital Nordjylland

Соавторы

Bispebjerg Hospital
Frederiksberg University Hospital

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июля 2026 г.

Первичное завершение (Оцененный)

1 декабря 2026 г.

Завершение исследования (Оцененный)

1 декабря 2026 г.

Даты регистрации исследования

Первый отправленный

25 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

25 июня 2026 г.

Первый опубликованный (Действительный)

1 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • N-20260014

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Individual participant data will not be shared publicly. The study includes a small sample and weight-bearing cone beam CT imaging data, which may carry a risk of participant re-identification even after pseudonymization. Study data will be stored on secure, access-controlled servers in accordance with GDPR and regional data protection requirements. Results will be reported only in aggregate form.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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