Comparison of Two Different Insole Types in Painful Flexible Flatfoot

Flatfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706327
• Other study ID #: GO 14/18-31
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: October 1, 2017
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2017
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flatfoot

Intervention

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.
• 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.

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Mediterranean University	Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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