Comparison of Two Different Insole Types in Painful Flexible Flatfoot

Not Applicable

Completed

• Conditions: Flatfoot
• Interventions: Device: CAD/CAM Insole; Device: Semi-custom Insole; Other: Control

• Registration Number: NCT02706327
• Lead Sponsor: Eastern Mediterranean University

Brief Summary

The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Results First Submitted: 2017-01-25
• Results First Submitted QC: 2017-06-18
• Results First Posted: 2017-07-14
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-01
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer),
• minimum of + 6 points on the foot posture index,

Exclusion Criteria

• treatment of the foot for at least six months,
• leg length discrepancy of more than 1 cm,
• history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD/CAM	CAD/CAM Insole	8-week follow-up with CAD/CAM insole and home based exercise program
Semi-custom	Semi-custom Insole	8-week follow-up with semi-custom insole and home based exercise program
Control	Control	8-week follow-up with placebo insole and home based exercise program

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity Measured by 100 mm Visual Analog Scale	Baseline and week 8	The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels.; Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week.; Changes were calculated as the difference between 8-week follow-up and baseline results.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life Assessed With Short Form-36 Scale	Baseline and week 8	The scale scores the health related quality of life with 0 and 100, minimum and maximum levels.; Each question is scored between 0-100 and the total score is found by dividing to number of question.; Higher score or positive change mean better quality of life in the scale. We used physical health part of it.; Changes were calculated as the difference between 8-week follow-up and baseline results.