The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Flatfoot, Flexible
• Intervention / Treatment: Device: arch insole and sham insole

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YenTing LIU; Phone Number: 1612 +886-229307930; Email: 95175@w.tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: arch 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.	Device: arch insole and sham insole; children wear insoles on feet
Sham Comparator: 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.	Device: arch insole and sham insole; children wear insoles on feet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Reach Test(FRT) from pre to post-intervention.	The Functional Reach Test (FRT) is a quick screen for determining balance capacity.	up to 10 minutes
Pediatric Berg Balance Scale	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.	up to 30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Study Chair: YenTing LIU, Master, Wang Fang Hospital, Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: N202106064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No