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| Name | Class |
|---|---|
| Hacettepe University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD/CAM | Experimental | 8-week follow-up with CAD/CAM insole and home based exercise program |
|
| Semi-custom | Experimental | 8-week follow-up with semi-custom insole and home based exercise program |
|
| Control | Placebo Comparator | 8-week follow-up with placebo insole and home based exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD/CAM Insole | Device | 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. |
| 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 |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasin Yurt, Dr. | Eastern Mediterranean University | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CAD/CAM | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | milimiters | Baseline and week 8 |
|
Through 8-week follow up period.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in foot pain during follow up period. | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yasin YURT | Eastern Mediterranean University | +905338724271 | fzt.yasinyurt@gmail.com |
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| ID | Term |
|---|---|
| D005413 | Flatfoot |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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|
| Semi-custom Insole | Device | 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. |
|
| Control | Other | 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole. |
|
| Baseline and week 8 |
| 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 |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Foot Posture Index | 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. | Mean | Standard Deviation | units on a scale |
|
| Calcaneal valgus angle | Mean | Standard Deviation | degree |
|
| International Physical Activity Questionnaire Short Form | Mean | Standard Deviation | kcal/week |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 8 |
|
|
|
|
| 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. | Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes. | Posted | Mean | Standard Deviation | units on a scale | In the same session after 8 weeks |
|
|
|
|
| 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. | Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes. | Posted | Mean | Standard Deviation | beat/meter | In the same session after 8 weeks |
|
|
|
|
| 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. | Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes. | Posted | Mean | Standard Deviation | percentage of distance | In the same session after 8 weeks |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. | 0 | 22 | 0 | 22 |
| EG002 | 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. | 0 | 23 | 1 | 23 |
|
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| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |