Comparison of Two Different Insole Types in Painful Flexible Flatfoot
Primary Purpose
Flatfoot
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAD/CAM Insole
Semi-custom Insole
Control
Sponsored by
About this trial
This is an interventional treatment trial for Flatfoot focused on measuring orthotic insoles, pain, quality of life, athletic performance
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CAD/CAM
Semi-custom
Control
Arm Description
8-week follow-up with CAD/CAM insole and home based exercise program
8-week follow-up with semi-custom insole and home based exercise program
8-week follow-up with placebo insole and home based exercise program
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02706327
First Posted
March 3, 2016
Last Updated
October 1, 2017
Sponsor
Eastern Mediterranean University
Collaborators
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT02706327
Brief Title
Comparison of Two Different Insole Types in Painful Flexible Flatfoot
Official Title
Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University
Collaborators
Hacettepe University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flatfoot
Keywords
orthotic insoles, pain, quality of life, athletic performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAD/CAM
Arm Type
Experimental
Arm Description
8-week follow-up with CAD/CAM insole and home based exercise program
Arm Title
Semi-custom
Arm Type
Experimental
Arm Description
8-week follow-up with semi-custom insole and home based exercise program
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
8-week follow-up with placebo insole and home based exercise program
Intervention Type
Device
Intervention Name(s)
CAD/CAM Insole
Intervention Description
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
Intervention Name(s)
Semi-custom Insole
Intervention Description
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
Other
Intervention Name(s)
Control
Intervention Description
15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
Primary Outcome Measure Information:
Title
Change in Pain Intensity Measured by 100 mm Visual Analog Scale
Description
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.
Time Frame
Baseline and week 8
Secondary Outcome Measure Information:
Title
Change in Quality of Life Assessed With Short Form-36 Scale
Description
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.
Time Frame
Baseline and week 8
Other Pre-specified Outcome Measures:
Title
Balance Was Assessed With a Dynamic Platform
Description
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.
Time Frame
In the same session after 8 weeks
Title
Six-minute Walk Physiological Cost Index Was Calculated
Description
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.
Time Frame
In the same session after 8 weeks
Title
Vertical Jump Height Was Measured With a Special Mat
Description
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.
Time Frame
In the same session after 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasin Yurt, Dr.
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Two Different Insole Types in Painful Flexible Flatfoot
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