Electrical Stimulation for Improving Balance in Diabetes

There will be a total of five study visits required for each patient. There will be one scheduled visit for baseline evaluation and four additional visits at 2 weeks, 4 weeks, 6 weeks during treatment and 8 weeks (2 weeks post stopping the treatment). The baseline visit will involve completion of a standardized intake form, which will include pertinent demographics such as age, height, weight, education level, occupation, and comorbidities of the study patient (see Table IV). Several clinical assessments will be performed at baseline as well as at each study visit to evaluate severity of neuropathy and skin perfusion as described in the table IV.

Clinical Assessments Baseline Medical History: This will include: duration and type of diabetes, type of diabetes medication (insulin, oral, combination therapy, diet), previous history of foot ulcers, previous history of falls, amputation (toe, foot), lower extremity bypass, lower extremity angioplasty, Coronary artery bypass surgery, cardiac angioplasty, arthritis, liver disease, osteoporosis, malignancy, and bone tumors. The Kaplan co‐morbidity index will be used to record disease severity. The New York Heart Association criteria will be used to classify congestive heart failure, and the National Kidney Foundation Disease Outcomes Quality Initiative Clinical Practice Guidelines for chronic kidney disease to stage kidney disease. Research staff will document all prescription and over‐the‐counter medications. Research staff will measure height and weight to determine body mass index (BMI).

Baseline Social Factors: Marital status, years of education, type of work, tobacco history (pack years, current smoker, current use of chewing tobacco, previous smoker, no tobacco history), drug history (current, previous history, no drug history), education, occupation, and alcohol history will be assessed.

Screening Test for frailty assessment: Fried Frailty Criteria: Weight loss >10 pounds in preceding year; Grip strength; Low levels of physical activity; 15 foot walk time; Exhaustion[13] Screening for cognitive problem: MMSE score [15] Foot questionnaire and foot exam

Baseline & each 2‐ week follow‐up (week 2, week 4, week 6, and week 8):

Peripheral Neuropathy: Research staff will evaluate Vibration Perception Threshold (VPT) Testing to evaluate large fiber neuropathy Semmes‐Weinstein monofilaments, and the Modified Neuropathy Disability Score. (Armstrong and Lawrence 1998) will be done. Research staff will assess light touch and pressure sensation at nine sites on each foot using 4, 10, 26, and 60 Semmes‐Weinstein gram monofilaments. (Diamond, Mueller et al. 1989) The Modified Neuropathy Disability Score is a scored clinical examination that includes Achilles deep tendon reflex, pressure, vibration sensation and temperature sensation in both feet.

Pain: Visual Analogue Scale Gait test: 8 sensors will be attached to the legs and lower back using comfortable straps and will be asked to walk 20 meters on a flat surface, two times. A third 20 meter walk will be performed with an additional distractive cognitive task (counting -1). The 4th test will be fast walking. Walking performance (e.g., speed, cadence, and stability) and spatio-temporal parameters of gait (e.g., velocity, stride time, gait inter-cycle variability, double support, and gait initiation) will be measured.

Balance test: The BalanSensTM kinematic sensor will be attached to the legs and lower back and will be used to measure the variation of subject's center of mass measured by the Romberg protocol including double stance, semi-tandem, and full-tandem tests. Patients will be asked to stand straight, feet together, hands crossed for 30 seconds, 20 seconds, and 15 seconds respectively for double stance test, semi-tendem, and full tandem tests with eyes open and closed.

Baseline and 6 weeks follow-up Activity Monitoring: Spontaneous daily physical activity will be monitored in home environment for 2 days using PAMSysTM Removal log: participants will be asked to note the time off, time on, and reason for removal if the PAMSysTM is removed during the 2 day collection period.

Quality of life questionnaire: SF12 Other assessment Fall log: participant will receive a log and agree to call the study overseer in the event of a fall during the 4 weeks study period.

Other patient information: if it was available patients record including medical history, neurological exam results, and physical examination may be gathered from patient record after authorization of the subject (see form T504a). In addition, subject photograph or video during experiment may be taken after subject's authorization.