Effect of a Semirigid Foot Insole in Flexible Pes Planus
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: Foot Insole.
- Кому может быть актуально
- Состояния в реестре: Flexible Flatfoot or Pes Planus. Базовые параметры: 18 лет — 35 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
- Египет
- 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
Immediate Effect of a Semirigid Foot Insole on Radiological Foot Angles in Flexible Pes Planus
Обзор
The goal of this clinical trial is to investigate the effect of a semirigid foot insole on radiological angle correction in people with asymptomatic flexible flat feet. The X-ray will be performed while standing barefoot one time and the other while standing on the insole from 2 views.
Подробное описание
This study will be conducted on 30 male and female subjects with flexible pes planus. Clinical diagnosis for flexible pes planus will be made through the navicular drop test (NDT) and the Foot Posture Index (FPI). The study included asymptomatic people with flexible pes planus. If the pain is greater than 3 out of 10 on the numeric pain rating scale in the last 3 months, aged 18-35, and BMI max 29.9 kg/cm². The subjects will be excluded if they have osteoarthritis of the joints of the foot (excluded by x-ray), foot deformities (e.g., hallux valgus), old fractures of the foot, previous injuries to the ankle, or previous surgeries to the lower limb. Calcaneal Spur, Foot and Ankle Ligament Tear, Systemic diseases such as rheumatoid arthritis (gouty arthritis, an autoimmune disease) and neurological diseases. The X-ray is the gold standard for assessment of adult-acquired flat foot deformity. Two views are used: anteroposterior (AP) and lateral views. A ruler and protractor will be used for manual measurements of X-ray foot. The subject will stand barefoot, and a weight-bearing X-ray will be taken from lateral and AP views once, without an insole, and another photo will be taken with an insole. The subject will stand barefoot, and a weight-bearing X-ray will be taken from lateral and AP views once, without an insole, and another photo will be taken with an insole.
The angles will be measured:
The gathered angles aim to evaluate the alignment of the foot's three arches. In the lateral view, the following angles will be measured and evaluated with without the insole: the lateral talo-1st metatarsal angle, the calcaneal inclination angle, the angle of Hibbs, the calcaneal-5th metatarsal angle, and the navicular height.
In the AP view, the following angles will be measured and evaluated with without the insole: The lateral talo-1st metatarsal angle, Talo-2nd metatarsal angle, The talocalcaneal angle, Talonavicular coverage angle and First-fifth metatarsal angle
Вмешательства
- Другое Foot Insole
Designed Semirigid foot insole
Первичные конечные точки
- Radiological foot angles [Срок оценки: Immediately after the insole insertion. The radiology will be taken one time barefoot and second time with the insole insertion, and the researcher will measure the foot angles pre- and post-insole to measure the correction.]
Критерии участия
Критерии включения
- Asymptomatic people with flexible pes planus. If the pain is greater than 3 out of 10 on the visual analog scale in the last 3 months, the patient is considered to have symptomatic flat feet (Mahdiyar et al., 2021).
- Aged 18-35.
- BMI max 29.9 kg/cm².
Критерии исключения
- Osteoarthritis of the joints of the foot (excluded by x-ray).
- Foot Deformities (e.g. Hallux Valgus)
- Old fractures of the foot.
- Previous injuries to the ankle.
- Previous surgeries to the lower limb. 6. Calcaneal Spur. 7. Foot and ankle ligaments tear.
8- Systemic diseases such as rheumatoid arthritis. (Gouty arthritis, autoimmune disease) 9. Neurological diseases.
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
- Лечение
Центры проведения
Египет · 1 центр
- October 6 University Hospital — Giza
Идентификаторы
NCT: NCT07389343 · Fatma-PhD