Development and clinical evaluation of a new dual purpose insole used for ulcer prevention and balance-enhancement in neuropathic individuals with diabetes
 
Neuropathy (nerve damage) commonly affects the feet of people with diabetes and can lead to foot and balance problems and falls. Insoles are commonly provided to protect diabetic feet from foot ulceration. This project aims to improve and extend the usefulness of insoles by designing and testing a new dual purpose insole to protect feet and enhance balance.
 
The first phase of the program is complete. People with diabetes who wear insoles were asked to recall the thoughts and feelings behind the footwear choices they make. Then people with diabetes who wear insoles and have recently fallen shared their views and experiences, to explore the perceived impact of footwear on balance. 
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We are about to begin recruitment for the second phase of this research program. The aim of our current study is to find out if the type of insoles and footwear worn by people with diabetes and neuropathy makes a difference to how steady people are when standing still and stepping up a step. High-tech laboratory based equipment will be used to study balance. 
 
The study findings will help inform the development of a new insole. Finally an exploratory study will compare new and traditional insoles to see which is best at improving the balance of people with diabetes.
 
This research is funded through a NIHR CAT Clinical Lectureship awarded to Dr Joanne Paton. The study design maximises clinical impact by transferring new knowledge directly to clinical practice. Each fall and related injury prevented could save a person from long term disability, increased dependence on others, loss of earnings, premature institutionalisation, social isolation and reduced quality.
 
 
Paton J, Roberts A, Bruce G, Marsden J. Does footwear affect balance? the views and experiences of people with diabetes who have fallen. 2013. Journal of the American Podiatric Medical Association. 103, 508-515
 
 
 

 
Understanding patients’ specific needs and concerns relating to footwear and insole design is recognized as fundamental to improving adherence. We conducted a patient-centered study to explore the experiences and views of people with diabetes and neuropathy who have recently fallen. Our goals were to understand participants’ perception regarding benefit of insoles and footwear for avoiding falls and to identify the balance enhancement features of insoles and footwear of relevance to people with diabetes and neuropathy.
 
Method: Sixteen eligible individuals were interviewed.
 
Results: Although the majority of participants did not believe that the footwear in which they fell contributed to their fall, most revealed how footwear choice influenced their balance confidence to undertake daily tasks. Most found their therapeutic footwear “difficult” to walk in, “heavy,” or “slippery bottomed.”
 
Conclusion: We suggest design recommendations for enhanced balance including a close fit with tight fastening, a lightweight and substantial tread, and a firm molded sole/insole.
 
 
 
 
Paton J, Thomason K, Trimble K, Metcalfe J, Marsden J. 2013. The effect of a forefoot offloading postoperative shoe on posture, balance, muscle activity and plantar pressure; a preliminary study. Journal of the American Podiatric Medical Association. 103, 1, 36-42.
 
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This related study was funded by the Orthopaedic Research Fund Derriford Hospital Plymouth. We investigated whether the forefoot off-loading postoperative shoe often issued to patients with diabetic foot ulceration, alters balance.
 
Methods: Laboratory measures of balance were compared in 14 healthy participants wearing either an off-loading shoe or a control shoe. The measurements were repeated with participants wearing a raise on the opposite side to balance out the difference in heel height.
 
Results: Compared with the control shoe, wearing the off-loading shoe moved body weight backward and altered muscle activity in the lower leg, apparently to maintain balance. These changes decreased when the shoe raise was worn on the opposite side.
 
Conclusions: Patients with diabetes and neuropathy can have weaker lower leg muscles than healthy subjects and therefore may not be able to adjust muscle activity to maintain balance. We suggest that patients with diabetes and neuropathy may find wearing an off-loading shoe with a shoe raise on the opposite side safer than an off-loading shoe on its own.