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Comparison of Two Different Insole Types in Painful Flexible Flatfoot

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ClinicalTrials.gov Identifier: NCT02706327
Recruitment Status : Completed
First Posted : March 11, 2016
Results First Posted : July 14, 2017
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Hacettepe University
Information provided by (Responsible Party):
Yasin YURT, Eastern Mediterranean University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Flatfoot
Interventions Device: CAD/CAM Insole
Device: Semi-custom Insole
Other: Control
Enrollment 67
Recruitment Details This study was conducted between January 2014 and January 2016 at an outpatient clinic. Eligible participants were randomly assigned into three groups using simple randomization procedures.
Pre-assignment Details  
Arm/Group Title CAD/CAM Semi-custom Control
Hide Arm/Group Description

8-week follow-up with computer-aided design/computer aided manufacturing (CAD/CAM) insole and home based exercise program

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.

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

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.

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

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

Period Title: Overall Study
Started 22 22 23
Completed 21 21 21
Not Completed 1 1 2
Reason Not Completed
Lost to Follow-up             1             1             2
Arm/Group Title CAD/CAM Semi-custom Control Total
Hide Arm/Group Description

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

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.

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

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.

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

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

Total of all reporting groups
Overall Number of Baseline Participants 22 22 23 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 23 participants 67 participants
21.73  (2.89) 23.05  (5.53) 21.09  (1.95) 21.94  (3.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 23 participants 67 participants
Female
13
  59.1%
12
  54.5%
14
  60.9%
39
  58.2%
Male
9
  40.9%
10
  45.5%
9
  39.1%
28
  41.8%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 22 participants 22 participants 23 participants 67 participants
23.03  (3.48) 24.11  (4.15) 23.32  (3.28) 23.48  (3.62)
Foot Posture Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 22 participants 22 participants 23 participants 67 participants
7.50  (1.73) 8.59  (1.76) 8.48  (2.04) 8.19  (1.89)
[1]
Measure Description:

This index measures posture (normal, pronated or supinated) of foot. Minimum-maximum values are -12 and +12 for the scale that 0 to +5 means normal foot posture, +6 to +9 means pronated foot, +10 and more means highly pronated and -1 to -4 means supinated foot, -5 to -12 means highly supinated.

Subjects with +6 and more were participated in this study.

Calcaneal valgus angle  
Mean (Standard Deviation)
Unit of measure:  Degree
Number Analyzed 22 participants 22 participants 23 participants 67 participants
6.36  (1.64) 6.68  (1.67) 6.22  (1.67) 6.42  (1.65)
International Physical Activity Questionnaire Short Form  
Mean (Standard Deviation)
Unit of measure:  Kcal/week
Number Analyzed 22 participants 22 participants 23 participants 67 participants
3438.81  (3543.30) 4731.27  (5392.45) 2824.54  (2221.46) 3688.98  (3389.92)
1.Primary Outcome
Title Change in Pain Intensity Measured by 100 mm Visual Analog Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAD/CAM Semi-custom Control
Hide Arm/Group Description:

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

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.

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

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.

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

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

Overall Number of Participants Analyzed 22 22 23
Mean (Standard Deviation)
Unit of Measure: milimiters
-31.40  (18.50) -34.54  (14.24) -12.08  (11.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAD/CAM, Semi-custom, Control
Comments Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not. A post-hoc test was used with Bonferroni correction.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A post-hoc test was used with Bonferroni correction and adjusted p-value was 0.016.
Method Kruskal-Wallis
Comments Effect sizes (Cohen’s d) were calculated for significant differences.
2.Secondary Outcome
Title Change in Quality of Life Assessed With Short Form-36 Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CAD/CAM Semi-custom Control
Hide Arm/Group Description:

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

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.

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

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.

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

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

Overall Number of Participants Analyzed 22 22 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.76  (11.04) 6.68  (6.24) 2.12  (4.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAD/CAM, Semi-custom, Control
Comments Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.547
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Balance Was Assessed With a Dynamic Platform
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
Arm/Group Title CAD/CAM Semi-custom Control
Hide Arm/Group Description:

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

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.

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

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.

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

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

Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.16  (0.77) -0.29  (0.85) -0.12  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAD/CAM, Semi-custom, Control
Comments Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Six-minute Walk Physiological Cost Index Was Calculated
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
Arm/Group Title CAD/CAM Semi-custom Control
Hide Arm/Group Description:

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

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.

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

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.

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

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

Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: beat/meter
0.017  (0.12) 0.007  (0.09) 0.029  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAD/CAM, Semi-custom, Control
Comments Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.842
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Vertical Jump Height Was Measured With a Special Mat
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
Arm/Group Title CAD/CAM Semi-custom Control
Hide Arm/Group Description:

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

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.

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

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.

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

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

Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: percentage of distance
0.35  (0.85) 0.19  (0.95) 0.87  (1.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAD/CAM, Semi-custom, Control
Comments Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame Through 8-week follow up period.
Adverse Event Reporting Description Deteriorating of foot pain was defined as a potential adverse event of insole and measured by using (0-100 mm) visual analog scale, that higher means worse, at the time subject was reported the event.
 
Arm/Group Title CAD/CAM Semi-custom Control
Hide Arm/Group Description

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

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.

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

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.

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

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

All-Cause Mortality
CAD/CAM Semi-custom Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CAD/CAM Semi-custom Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)      0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CAD/CAM Semi-custom Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)      1/23 (4.35%)    
Musculoskeletal and connective tissue disorders       
Increase in foot pain during follow up period. * [1]  0/22 (0.00%)  0 0/22 (0.00%)  0 1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Subjects were asked to report if their foot pain got worse at any time.
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yasin YURT
Organization: Eastern Mediterranean University
Phone: +905338724271
EMail: fzt.yasinyurt@gmail.com
Layout table for additonal information
Responsible Party: Yasin YURT, Eastern Mediterranean University
ClinicalTrials.gov Identifier: NCT02706327     History of Changes
Other Study ID Numbers: GO 14/18-31
First Submitted: March 3, 2016
First Posted: March 11, 2016
Results First Submitted: January 25, 2017
Results First Posted: July 14, 2017
Last Update Posted: November 1, 2017