The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

NCT ID: NCT05533762

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-12-31

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.

Conditions

Flatfoot, Flexible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

arch insole and sham insole

Intervention Type: DEVICE

children wear insoles on feet

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.

Group Type: SHAM_COMPARATOR

arch insole and sham insole

Intervention Type: DEVICE

children wear insoles on feet

Interventions

arch insole and sham insole

children wear insoles on feet

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YenTing LIU, Master

Role: STUDY_CHAIR

Wang Fang Hospital, Taipei Medical University

Central Contacts

YenTing LIU

Role: CONTACT

95175@w.tmu.edu.tw

+886-229307930 ext. 1612

Other Identifiers

N202106064

Identifier Type: -

Identifier Source: org_study_id