Flatfoot
Conditions
Keywords
orthotic insoles, pain, quality of life, athletic performance
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.
Interventions
DEVICECAD/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.
DEVICESemi-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.
OTHERControl
15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
Sponsors
Hacettepe University
Eastern Mediterranean University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by 100 mm Visual Analog Scale | Baseline and week 8 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Assessed With Short Form-36 Scale | Baseline and week 8 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Balance Was Assessed With a Dynamic Platform | In the same session after 8 weeks | 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. |
| Six-minute Walk Physiological Cost Index Was Calculated | In the same session after 8 weeks | 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. |
| Vertical Jump Height Was Measured With a Special Mat | In the same session after 8 weeks | 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. |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| CAD/CAM 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. | 22 |
| Semi-custom 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. | 22 |
| Control 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. | 23 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | CAD/CAM | Semi-custom | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 21.73 years STANDARD_DEVIATION 2.89 | 23.05 years STANDARD_DEVIATION 5.53 | 21.09 years STANDARD_DEVIATION 1.95 | 21.94 years STANDARD_DEVIATION 3.78 |
| Body Mass Index | 23.03 kg/m2 STANDARD_DEVIATION 3.48 | 24.11 kg/m2 STANDARD_DEVIATION 4.15 | 23.32 kg/m2 STANDARD_DEVIATION 3.28 | 23.48 kg/m2 STANDARD_DEVIATION 3.62 |
| Calcaneal valgus angle | 6.36 degree STANDARD_DEVIATION 1.64 | 6.68 degree STANDARD_DEVIATION 1.67 | 6.22 degree STANDARD_DEVIATION 1.67 | 6.42 degree STANDARD_DEVIATION 1.65 |
| Foot Posture Index | 7.50 units on a scale STANDARD_DEVIATION 1.73 | 8.59 units on a scale STANDARD_DEVIATION 1.76 | 8.48 units on a scale STANDARD_DEVIATION 2.04 | 8.19 units on a scale STANDARD_DEVIATION 1.89 |
| International Physical Activity Questionnaire Short Form | 3438.81 kcal/week STANDARD_DEVIATION 3543.3 | 4731.27 kcal/week STANDARD_DEVIATION 5392.45 | 2824.54 kcal/week STANDARD_DEVIATION 2221.46 | 3688.98 kcal/week STANDARD_DEVIATION 3389.92 |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 14 Participants | 39 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 9 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 1 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 23 |
Outcome results
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.
Time frame: Baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD/CAM | Change in Pain Intensity Measured by 100 mm Visual Analog Scale | -31.40 milimiters | Standard Deviation 18.5 |
| Semi-custom | Change in Pain Intensity Measured by 100 mm Visual Analog Scale | -34.54 milimiters | Standard Deviation 14.24 |
| Control | Change in Pain Intensity Measured by 100 mm Visual Analog Scale | -12.08 milimiters | Standard Deviation 11.82 |
Comparison: 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.p-value: <0.001Kruskal-Wallis
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.
Time frame: Baseline and week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD/CAM | Change in Quality of Life Assessed With Short Form-36 Scale | 7.76 units on a scale | Standard Deviation 11.04 |
| Semi-custom | Change in Quality of Life Assessed With Short Form-36 Scale | 6.68 units on a scale | Standard Deviation 6.24 |
| Control | Change in Quality of Life Assessed With Short Form-36 Scale | 2.12 units on a scale | Standard Deviation 4.75 |
Comparison: 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.p-value: 0.547Kruskal-Wallis
Other Pre-specified
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.
Time frame: In the same session after 8 weeks
Population: Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD/CAM | Balance Was Assessed With a Dynamic Platform | -0.16 units on a scale | Standard Deviation 0.77 |
| Semi-custom | Balance Was Assessed With a Dynamic Platform | -0.29 units on a scale | Standard Deviation 0.85 |
| Control | Balance Was Assessed With a Dynamic Platform | -0.12 units on a scale | Standard Deviation 1.08 |
Comparison: 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.p-value: 0.895Kruskal-Wallis
Other Pre-specified
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.
Time frame: In the same session after 8 weeks
Population: Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD/CAM | Six-minute Walk Physiological Cost Index Was Calculated | 0.017 beat/meter | Standard Deviation 0.12 |
| Semi-custom | Six-minute Walk Physiological Cost Index Was Calculated | 0.007 beat/meter | Standard Deviation 0.09 |
| Control | Six-minute Walk Physiological Cost Index Was Calculated | 0.029 beat/meter | Standard Deviation 0.16 |
Comparison: 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.p-value: 0.842Kruskal-Wallis
Other Pre-specified
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.
Time frame: In the same session after 8 weeks
Population: Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAD/CAM | Vertical Jump Height Was Measured With a Special Mat | 0.35 percentage of distance | Standard Deviation 0.85 |
| Semi-custom | Vertical Jump Height Was Measured With a Special Mat | 0.19 percentage of distance | Standard Deviation 0.95 |
| Control | Vertical Jump Height Was Measured With a Special Mat | 0.87 percentage of distance | Standard Deviation 1.38 |
Comparison: 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.p-value: 0.848Kruskal-Wallis