The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

NCT05533762 | Unknown

• 1 other identifier: N202106064
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Flatfoot, Flexible

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Center of pressure (CoP) from pre to post-intervention.

  up to 30 minutes

Study Arms (2)

arch insole

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.

Device: arch insole and sham insole

sham insole

SHAM COMPARATOR

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

Interventions

arch insole and sham insole DEVICE

children wear insoles on feet

arch insole; sham insole

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children presenting symptomatic flexible flatfoot only

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• YenTing LIU, Master

  Wang Fang Hospital, Taipei Medical University

  STUDY CHAIR

Central Study Contacts

YenTing LIU

CONTACT

+886-229307930; 95175@w.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: September 9, 2022
• Study Start: September 15, 2022
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share