Comparison of Two Different Insole Types in Painful Flexible Flatfoot

Eastern Mediterranean University

Status: Completed

Conditions: Flatfoot

Treatments: Other: Control; Device: CAD/CAM Insole; Device: Semi-custom Insole

Study type: Interventional

Funder types: Other

Identifiers

NCT02706327

GO 14/18-31

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 3 patient groups, including a placebo group

CAD/CAM

Experimental group

Description:

8-week follow-up with CAD/CAM insole and home based exercise program

Treatment:

Device: CAD/CAM Insole

Semi-custom

Experimental group

Description:

8-week follow-up with semi-custom insole and home based exercise program

Treatment:

Device: Semi-custom Insole

Control

Placebo Comparator group

Description:

8-week follow-up with placebo insole and home based exercise program

Treatment:

Other: Control