The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

Not Applicable

• Conditions: Flatfoot, Flexible
• Interventions: Device: arch insole and sham insole

• Registration Number: NCT05533762
• Lead Sponsor: Taipei Medical University WanFang Hospital

Brief Summary

Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Study First Posted: 2022-09-09
• Last Update Posted: 2022-09-09
• Study Start: 2022-09-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Children presenting symptomatic flexible flatfoot only

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sham insole	arch insole and sham insole	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.
arch insole	arch insole and sham insole	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.

Primary Outcome Measures

Name	Time	Method
Change in Functional Reach Test(FRT) from pre to post-intervention.	up to 10 minutes	The Functional Reach Test (FRT) is a quick screen for determining balance capacity.
Pediatric Berg Balance Scale	up to 30 minutes	Pediatric Berg Balance Scale was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.; Maximum score is 56 ,and minimum values is 0. Score 54-56 means a better outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Center of pressure (CoP) from pre to post-intervention.	up to 30 minutes	The center of pressure (CoP) measures derived from the foot pressure mat and force plate of RSSCAN system.