Background: Neurodegenerative diseases like diabetes can significantly impair patients' postural balance and gait. These negative alterations in balance and gait coupled with peripheral neuropathy (PN) can dramatically reduce patients' ability to perform activities of daily living and also put them on high fall-risk. The purpose of this study is to treat balance deficit due to diabetes and PN using a home wearable technology based on plantar electrical stimulation. Methods: An innovative and low-cost therapeutic electrical stimulation (ES) device initially designed for pain management (SENSUS, NEUROMetrix Inc, MA, USA) was customized to deliver electrical stimulation to plantar regions of interest, Figure 1. Since neuropathy patients lack plantar sensations, the intensity of stimulation was set based on perception on senate skin. The therapy session was performed at home for 2 hours a day per week on each foot (at night before sleep and morning). The effect of ES was quantified by measuring changes in sway of ankle, hip and center of mass (CoM) and gait changes using body-worn sensors (LegSySTM, Biosensics LLC, MA, USA). Results: Five patients were recruited so far (Age 53.8±5.7, BMI=30±5 Kg/m2) with average vibration perception threshold score of 26.2±5.3V. Preliminary data analysis included baseline measurements on 5 patients and follow up on 3 after a period of one week. On average we observed a reduction of 23% (1.39±0.67deg to 1.07±0.78deg), 25% (1.08±0.85deg to 0.82±0.4deg) and 22% (0.25±0.16cm2 to 0.19±0.08 cm2) in ankle, hip and body sway during eyes open assessment. For gait we observed reduction in gait velocity (11%), increase in CoM sway (9.4%) and increase in double support (17.5%) during steady state gait. Interestingly, there was 34% decrease in gait unsteadiness during steady state gait. There was no changes in knee range of motion and stride length. Conclusion: The preliminary results from this study have demonstrated that plantar electrical stimulation may be beneficial for patients with diabetic peripheral neuropathy in improving postural stability. Immediate improvements in balance are more prominent than gait. The reductions in gait unsteadiness are promising; it seems that patients are walking more cautious post therapy. Follow up measurements after continued use of device for months will reveal significant changes in gait and balance.


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