- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407960
The Clinical Study of Foot Function Index in Adolescent Flatfoot
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
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Shanhai
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Shanghai, Shanhai, China, 200000
- Shanghai University of Traditional Chinese Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The FFI questionnaire
Time Frame: 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).
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The first week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plantar stress test
Time Frame: 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.
|
The first week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical consultation
Time Frame: The first week
|
we measured radiography images of the Meary and pitch angles using the picture archiving and communication system (PACS) of the hospital imaging platform to determine flatfoot severity.
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The first week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SH9H-2022-T125-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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