Suspended

The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

What is being tested

arch insole and sham insole

Device

Who is being recruted

Congenital Abnormalities+8

+ Talipes

+ Flatfoot

From 3 to 10 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: September 2022

See protocol details

Summary

Principal SponsorTaipei Medical University WanFang Hospital

Study ContactYenTing LIU

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2022

Actual date on which the first participant was enrolled.

Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight. Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain. In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.

Official TitleThe Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

NCT05533762

Principal SponsorTaipei Medical University WanFang Hospital

Study ContactYenTing LIU

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 10 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesTalipesFlatfootFoot DeformitiesFoot Deformities, AcquiredFoot Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLimb Deformities, CongenitalLower Extremity Deformities, Congenital

Criteria

1 inclusion criteria required to participate

Children presenting symptomatic flexible flatfoot only

1 exclusion criteria prevent from participating

Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Half of the subjects are randomly assigned to assess balance capacity with arch insole first. Three day wash out, the subjects are assess balance capacity with sham insole.

Group II

Sham

Half of the subjects are randomly assigned to assess balance capacity with sham insole first. Three day wash out, the subjects are assess balance capacity with arch insole.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers