Translation, Cross-cultural Adaptation, and Validation of the Foot Posture Index (FPI-6) in Spain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Intra-rater and Inter-rater Reliability of the Spanish FPI-6
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 89 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
General Population (Children and Adults)
This group includes participants of all ages, including children (from 5 years old) and adults. The study aims to evaluate the psychometric properties of the Spanish version of the Foot Posture Index (FPI-6) across a diverse age range to ensure its validity and reliability in the general Spanish-speaking population
干预措施: Spanish version of the Foot Posture Index (FPI-6) (Other)
结局指标
主要结局
Intra-rater and Inter-rater Reliability of the Spanish FPI-6
时间窗: Baseline and 7-14 days later
Consistency of the Foot Posture Index (FPI-6) scores evaluated through the Intraclass Correlation Coefficient (ICC). Intra-rater reliability will be assessed by one examiner repeating the test after 1-2 weeks. Inter-rater reliability will be assessed by two examiners evaluating each subject with a one-hour interval.
Internal Consistency of the Spanish FPI-6
时间窗: At Baseline (Day 1)
Measured using Cronbach's alpha to ensure that all six items of the FPI-6 contribute coherently to the total score. A value \> 0.70 is expected.
次要结局
- Criterion Validity(At Baseline (Day 1))
研究者
Paloma López Ros
Assistant Professor, PhD
Universidad Miguel Hernandez de Elche