The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

T

Taipei Medical University

Status

Not yet enrolling

Conditions

Flatfoot, Flexible

Treatments

Device: arch insole and sham insole

Study type

Interventional

Funder types

Other

Identifiers

NCT05533762
N202106064

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

3 to 10 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 2 patient groups

arch insole
Active Comparator group
Description:
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.
Treatment:
Device: arch insole and sham insole
sham insole
Sham Comparator group
Description:
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.
Treatment:
Device: arch insole and sham insole

Trial contacts and locations

0

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Central trial contact

YenTing LIU

Data sourced from clinicaltrials.gov

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