Comparison of Two Different Insole Types in Painful Flexible Flatfoot

NCT02706327 | Completed Results

• 1 other identifier: GO 14/18-31
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Flatfoot

Keywords

orthotic insoles; pain; quality of life; athletic performance

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Measured by 100 mm Visual Analog Scale

  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.

  Baseline and week 8

Secondary Outcomes (1)

• Change in Quality of Life Assessed With Short Form-36 Scale

  Baseline and week 8

Other Outcomes (3)

• Balance Was Assessed With a Dynamic Platform

  In the same session after 8 weeks

• Six-minute Walk Physiological Cost Index Was Calculated

  In the same session after 8 weeks

• Vertical Jump Height Was Measured With a Special Mat

  In the same session after 8 weeks

Study Arms (3)

CAD/CAM

EXPERIMENTAL

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

Device: CAD/CAM Insole

Semi-custom

EXPERIMENTAL

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

Device: Semi-custom Insole

Control

PLACEBO COMPARATOR

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

Other: Control

Interventions

CAD/CAM Insole 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.

CAD/CAM

Semi-custom Insole 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.

Semi-custom

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead
• Hacettepe University: collaborator

MeSH Terms

Conditions

Flatfoot; Pain

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The young average age of our study population could limit the generalizability of our results and the two-month follow-up interval was sufficient to see the benefit of insoles but may not be long enough to determine whether the benefit will last.

Results Point of Contact

• Title: Yasin YURT
• Organization: Eastern Mediterranean University

fzt.yasinyurt@gmail.com

+905338724271

Study Officials

• Yasin Yurt, Dr.

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 11, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 1, 2017
• Results First Posted: July 14, 2017

Record last verified: 2017-10