The Clinical Study of Foot Function Index in Adolescent Flatfoot

Completed

• Conditions: Foot Function Index, Flat Foot, Dynamic Plantar Pressure, Reliability, Validity

• Registration Number: NCT06407960
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-02-01
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The FFI questionnaire	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).

Secondary Outcome Measures

Name	Time	Method
Plantar stress test	The first week	Plantar pressure data were detected and acquired exclusively from the patients. The main outcome measures included contact area, peak pressure, and peak force.

Trial Locations

Locations (1)

Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanhai, China