Clinical Trial: The Analysis and Applications of Dynamic Impression Insole
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Dynamic Impression Insoles on Plantar Pressure and Pain in Persons With Metatarsal Pain
Brief Summary: The aim of the study was to investigate the effectiveness of dynamic impression insoles on plantar pressure and pain reduction. A dynamic impression insole was made by sequential padding with Plastazote and P-cell under daily walking compression. The pain levels and plantar pressure with the use of dynamic impression insole were assessed and compared with 7-mm Ethylene Vinyl Acetate (EVA) control, 9-mm uncompressed Plastazote and custom molded insoles. Plantar pressure was measured by a Pedar-X mobile system, and pain level was assessed using a Visual Analog Scales.
Detailed Summary: Toe deformities may cause prominence of the metatarsal heads (MTH) and distal displacement of fat-pad cushion beneath the MTH, resulting in the metatarsal pain. Foot pain frequently leads to limitation of activities of daily life and deterioration of life quality. Foot orthoses have been commonly used in clinical practice to reduce plantar pressure and subsequent pain. However, the therapeutic efficacies of custom molded insoles with a metatarsal support vary widely with their designs and materials. We designed a simple and effective method that a dynamic impression insole was made by sequential padding of foams with different compressibility under successive dynamic impression in daily walking. A piece of metatarsal pad and arch support made of EVA was attached to the bottom of impressed insole just proximal to the first, second, and third MTH according to the foot impression. Fifty participants with metatarsal pain were recruited from the podiatry outpatient clinic of Taipei Veteran General Hospital. The plantar pressure measurements were carried out under a comfortable and stable walking speed preferred by the participants one month after the dynamic impression and custom molded insoles were well fabricated. All pressure data were processed with the Novel-Win Multimask analysis software. The purposes of this study were to investigate the biomechanics of dynamic impression insole in plantar pressure and pain reduction.
Sponsor: Taipei Veterans General Hospital, Taiwan
Current Primary Outcome: Change from baseline in peak plantar pressure value with different insoles [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change from baseline in pain levels using Visual Analog Scales [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Taipei Veterans General Hospital, Taiwan
Dates:
Date Received: October 19, 2011
Date Started: April 2011
Date Completion:
Last Updated: June 24, 2012
Last Verified: June 2012
