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临床试验/NCT06407960
NCT06407960已完成不适用

The Clinical Study of the Reliability and Validity of the Foot Function Index in the Application of Pediatric and Adolescent Flatfoot, and Its Correlation With Dynamic Plantar Pressure

Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
97
试验地点
1
主要终点
The FFI questionnaire

研究概览

简要总结

Using dynamic plantar pressure data during walking, combined with the FFI scores of adolescents, aids doctors and rehabilitation therapists in conducting more accurate, objective, and scientific evaluations of the functional parameters of the foot for appropriate rehabilitation treatment. Clinical studies on flat feet mainly focus on imaging diagnosis, gait characteristics, orthopedic insole studies, and different surgical treatment schemes related to flat foot injuries. However, few studies have analyzed the dynamic plantar pressure characteristics of flat feet to guide clinical interventions, as well as the correlation between the subjective perception of FFI and objective biomechanical parameter characteristics to analyze the validity of FFI and elucidate the physiological characteristics of foot diseases.

Specific purpose of this study Therefore, the purpose of our study was to clarify the reliability and validity of the application of the FFI in flatfoot and the correlation between the FFI and dynamic plantar pressure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 7-18 years old. Arch development begins to stabilize around age 7 [19]; therefore, preschool children under 7 were excluded. Ability to maintain a static standing posture unassisted; bilateral flexible flatfoot (where the heel is valgus and the arch collapses on both sides); no congenital malformation or injury of the lower limbs; normal body mass index (BMI); no previous surgery or corrective treatment for flatfoot problems; and no obvious abnormal gait and posture.

排除标准

  • Preschool children under 7 years of age are excluded. ① Foot fracture or surgical history in the past six months; ② There are muscular nervous system diseases and syndrome affecting gait and posture, such as knee valgus, knee varus, legs unequal length or scoliosis; ③BMI≥28 kg/m².

结局指标

主要结局

The FFI questionnaire

时间窗: The first week

The FFI comprises 23 questions divided into 3 subdomains to evaluate the impact of foot pathology: pain (9 questions), disability (9 questions), and activity restrictions (5 questions). In combination with the visual analog scale, each question was assigned a score of 0-10 (0 for no pain or difficulty and 10 for maximum pain or difficulty).

次要结局

  • Plantar stress test(The first week)

研究者

发起方
Shanghai University of Traditional Chinese Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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