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Comparison of Two Different Insole Types in Painful Flexible Flatfoot

NCT ID: NCT02706327

Last Updated: 2017-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Flatfoot

Keywords

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orthotic insoles pain quality of life athletic performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CAD/CAM

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

Group Type EXPERIMENTAL

CAD/CAM Insole

Intervention Type DEVICE

A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.

Semi-custom

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

Group Type EXPERIMENTAL

Semi-custom Insole

Intervention Type DEVICE

Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.

Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.

Interventions

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CAD/CAM Insole

A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.

Intervention Type DEVICE

Semi-custom Insole

Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.

Intervention Type DEVICE

Control

15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role collaborator

Eastern Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

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Yasin YURT

Assist. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasin Yurt, Dr.

Role: PRINCIPAL_INVESTIGATOR

Eastern Mediterranean University

Other Identifiers

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GO 14/18-31

Identifier Type: -

Identifier Source: org_study_id