Comparison of Two Different Insole Types in Painful Flexible Flatfoot

Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot

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.

Study Overview

• Status: Completed
• Conditions: Flatfoot
• Intervention / Treatment: Device: CAD/CAM Insole; Device: Semi-custom Insole; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAD/CAM; 8-week follow-up with CAD/CAM insole and home based exercise program	Device: 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.
Experimental: Semi-custom; 8-week follow-up with semi-custom insole and home based exercise program	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.
Placebo Comparator: Control; 8-week follow-up with placebo insole and home based exercise program	Other: Control; 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life Assessed With Short Form-36 Scale	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.	Baseline and week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance Was Assessed With a Dynamic Platform	Dynamic platform was the equipment used in balance assessment. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. The software calculates balance value between 0 and 5 that lower value means better balance score. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, negative changes mean better balance score with insole.	In the same session after 8 weeks
Six-minute Walk Physiological Cost Index Was Calculated	Physiological cost index was calculated by taking heart rate with finger oximeter and walking distance after a six-minute walk test. The result is calculated by dividing one minute heart rate (beat) to walking distance (meter). Lower values mean better physiological cost. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, negative changes mean better score with insole.	In the same session after 8 weeks
Vertical Jump Height Was Measured With a Special Mat	Sensor mat was used in vertical jump measurement. The result is the distance (cm) that was jumped vertically and it is normalized by dividing the distance to length of subject in order to get percentage of jump distance. Higher values mean better vertical jump performance. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, positive changes mean better score with insole.	In the same session after 8 weeks

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Collaborators: Hacettepe University
• Investigators: Principal Investigator: Yasin Yurt, Dr., Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 1, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: pain; quality of life; orthotic insoles; athletic performance
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: GO 14/18-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided