N L Becker1, T Obens, J Weisser, S Flick. 1. Facharztpraxis für Orthopädie, Sportmedizin, Chirotherapie, Akupunktur sowie Institut für angewandte Biomechanik, Wilhelmstr. 134, 72074, Tübingen, Deutschland, norbert.becker@uni-tuebingen.de.
Abstract
BACKGROUND: From an orthopedic point of view, wearing conventional ready to wear shoes negatively affects the front transverse arch of the human foot by forcing it into an unnatural inverted position. OBJECTIVES: The aim of the present orthopedic application study was to conduct a standardized assessment of the biomechanical effect of a newly developed, longitudinally flexible and cross stable spring steel insole by means of pedobarographic measurements and by means of a supplementary questioning of the participants. MATERIAL AND METHODS: In order to do this a total of 33 healthy adult participants were recruited in summer 2013. The randomized, blinded and controlled main study compared the cross stable insole made from spring steel with a flat, ordinary control insole made from ethylene vinyl acetate by means of pedobarographic in-shoe measurements at the forefoot. Additionally, the subjectively perceived effect of the steel insole with respect to comfort, restricted mobility and pain was assessed in a randomized, blinded and controlled ancillary study, using a cross-over design. RESULTS: Both the plantar peak pressure and the plantar force-time integral were significantly higher with the spring steel insole, especially in the central forefoot. In the subsequent test phase lasting several weeks during which the participants were asked to wear the spring steel insole, they rarely complained about problems and in particular did not report negative effects regarding comfort, restricted mobility and pain compared to the ordinary control insoles. CONCLUSION: The present study was conducted according to high methodological standards and proved for the first time that the tested spring steel insoles have a positive effect on the human forefoot. The cross stability increases the pressure in the median ball area, prevents the unnatural inverted position of the forefoot and thus creating an effect which is comparable to walking barefoot. As the participants did not judge this orthopedic effect of the cross stability as being uncomfortable, such an insole could be used a millionfold as a primary prevention in conventional shoes.
RCT Entities:
BACKGROUND: From an orthopedic point of view, wearing conventional ready to wear shoes negatively affects the front transverse arch of the human foot by forcing it into an unnatural inverted position. OBJECTIVES: The aim of the present orthopedic application study was to conduct a standardized assessment of the biomechanical effect of a newly developed, longitudinally flexible and cross stable spring steel insole by means of pedobarographic measurements and by means of a supplementary questioning of the participants. MATERIAL AND METHODS: In order to do this a total of 33 healthy adult participants were recruited in summer 2013. The randomized, blinded and controlled main study compared the cross stable insole made from spring steel with a flat, ordinary control insole made from ethylene vinyl acetate by means of pedobarographic in-shoe measurements at the forefoot. Additionally, the subjectively perceived effect of the steel insole with respect to comfort, restricted mobility and pain was assessed in a randomized, blinded and controlled ancillary study, using a cross-over design. RESULTS: Both the plantar peak pressure and the plantar force-time integral were significantly higher with the spring steel insole, especially in the central forefoot. In the subsequent test phase lasting several weeks during which the participants were asked to wear the spring steel insole, they rarely complained about problems and in particular did not report negative effects regarding comfort, restricted mobility and pain compared to the ordinary control insoles. CONCLUSION: The present study was conducted according to high methodological standards and proved for the first time that the tested spring steel insoles have a positive effect on the human forefoot. The cross stability increases the pressure in the median ball area, prevents the unnatural inverted position of the forefoot and thus creating an effect which is comparable to walking barefoot. As the participants did not judge this orthopedic effect of the cross stability as being uncomfortable, such an insole could be used a millionfold as a primary prevention in conventional shoes.