NCT Number: NCT02706327
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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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Eastern Mediterranean University
Other
Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot
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