Electrical Stimulation for Improving Balance in Diabetes
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): SENSUS Pain Management System
Intervention type(s): Device
Intervention description(s): An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment