Electrical Stimulation for Improving Balance in Diabetes

Detailed Summary

This is a double-blind randomized clinical trial. Both patients and the podiatrist that will evaluate and monitor study patients will be blinded to electrical stimulation application. The manufacturer of the units will be asked to not inform which patient received which unit. Each unit will be coded with a unique identification number, and the manufacturer units revealed their status, placebo or electric stimulation, only at the end of data collection for the last patient. Subsequently, the investigators could match the status of the identification numbers with the corresponding units to start analyzing the data. Patients that receive an activated electrical stimulation unit will receive a standard dose of 50 volts as described above. The investigator will enroll a cohort of 80 diabetes (type II) patients with peripheral neuropathy (see section 6 for sample size justification). The diagnosis of diabetes mellitus will be based on World Health Organization criteria.(World-Health-Organization 1999). The inclusion and exclusion criteria are described in table III. The clinical assessments are described in table IV. The investigator will discuss the study design, duration, and its risks with potential subjects asked to participate. The participant will be provided with a consent form to read at their leisure. The investigator will be available to answer questions or provide more explanation as requested by potential participants and their family.

Study Details

Timeline

Interventions