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Набор скоро начнётся NCT07590297

Translation, Cross-cultural Adaptation, and Validation of the FPI-6 in Spain

— Наблюдательное Foot Deformities Flatfoot

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: Spanish version of the Foot Posture Index (FPI-6), Spanish version of the Foot Posture Index (FPI-6).
Кому может быть актуально
Состояния в реестре: Foot Deformities, Flatfoot. Базовые параметры: 6 лет — 89 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 →

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Официальное название

Translation, Cross-cultural Adaptation, and Validation of the Foot Posture Index (FPI-6) in Spain

Обзор

The objective of this study is to translate, cross-culturally adapt, and validate the Spanish version of the Foot Posture Index (FPI-6). This clinical tool is widely used to evaluate standing foot posture through six visual criteria. The study aims to provide Spanish-speaking clinicians and researchers with a reliable and valid instrument to assess foot posture in the Spanish population, ensuring that the psychometric properties of the original scale are preserved

Подробное описание

This study follows a prospective, observational design and will be carried out in two phases:

Phase 1: Translation and Cross-Cultural Adaptation. Following international standards (forward-backward translation method), the original English FPI-6 will be translated into Spanish by two independent translators. A synthesis version will be created, followed by a back-translation into English to ensure conceptual equivalence. A pilot test will be conducted to ensure the clarity of the items.

Phase 2: Validation and Psychometric Evaluation. The Spanish version of the FPI-6 will be administered to a sample of participants. To evaluate reliability, intra-rater and inter-rater reliability will be calculated using the Intraclass Correlation Coefficient (ICC). Internal consistency will be assessed using Cronbach's alpha. Construct validity will be analyzed by comparing FPI-6 scores with other validated clinical measures of foot posture

Вмешательства

  • Другое Spanish version of the Foot Posture Index (FPI-6)
    The assessment consists of the clinical application of the Spanish version of the Foot Posture Index (FPI-6). This is a non-invasive observational method where the investigator evaluates six specific criteria of the foot while the participant stands in a relaxed position. The six criteria include: talar head palpation, supra and infra-malleolar curvature, calcaneal frontal plane position, prominence in the region of the talonavicular joint, congruence of the internal longitudinal arch, and abduc
  • Другое Spanish version of the Foot Posture Index (FPI-6)
    Clinical assessment of standing foot posture using the Spanish translation of the Foot Posture Index (FPI-6). This tool evaluates six criteria: talar head palpation, supra and infra-malleolar curvature, calcaneal frontal plane position, prominence in the region of the talonavicular joint, congruence of the internal longitudinal arch, and abduction/adduction of the forefoot on the rearfoot. Each item is scored on a scale from -2 to +2. The tool will be applied to a sample of children (from 5 year

Первичные конечные точки

  • Intra-rater and Inter-rater Reliability of the Spanish FPI-6 [Срок оценки: Baseline and 7-14 days later]
  • Internal Consistency of the Spanish FPI-6 [Срок оценки: At Baseline (Day 1)]
Вторичные конечные точки (1)
  • Criterion Validity [Срок оценки: At Baseline (Day 1)]

Критерии участия

Критерии включения

  • Participants aged between 6 and 89 years
  • Ability to understand and sign the informed consent form. In the case of minors, written informed consent from parents or legal guardians and child's assent (where applicable) are required
  • Ability to maintain a relaxed standing position unassisted for the duration of the clinical assessment

Критерии исключения

  • History of major surgery or significant trauma in the lower limbs or feet.
  • Presence of open wounds or active skin infections on the feet at the time of the examination.
  • Neurological or musculoskeletal conditions that severely affect balance or standing posture.
  • Cognitive impairment that prevents the participant from following simple clinical instructions

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available. PMID 11124735
  • Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21. PMID 16182419
  • Redmond AC, Crane YZ, Menz HB. Normative values for the Foot Posture Index. J Foot Ankle Res. 2008 Jul 31;1(1):6. doi: 10.1186/1757-1146-1-6. PMID 18822155

Идентификаторы

NCT: NCT07590297 · DCC.PLR.260209

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗