Electrical Stimulation for Improving Balance in Diabetes

NCT02337218 | Completed Results FDA Device

• 1 other identifier: 062012-035
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• Balance Test (BalanSense Device)

  Postural control changes will be measured using the BalanSense device in subjects assigned to use the active Electrical Stimulation (intervention group) and subjects assigned to non-functional stimulator (sham group). Balance will be assessed for both groups at baseline and at each follow-up visit, weeks 2, 4, 6 and 8. Static balance and postural compensatory strategy will be assessed using the body worn sensor technology. Measurements taken with eyes closed and eyes open.

  8 weeks

• Peripheral Neuropathy Measured by Vibration Perception Threshold (VPT) Testing

  We will evaluate Vibration Perception Threshold (VPT) Testing to evaluate large fiber neuropathy in the feet.

  8 weeks

• Gait Test (LegSys System)

  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 at weeks 2, 4, 6 and 8.

  8 weeks

Study Arms (2)

SENSUS Pain Management System

ACTIVE COMPARATOR

Electrical stimulation device worn on the leg delivering a dose of 50 volts.

Device: SENSUS Pain Management System

SENSUS Pain Management System - Sham

SHAM COMPARATOR

Electrical stimulation device worn on the leg and programmed to deliver no stimulation.

Device: SENSUS Pain Management System

Interventions

SENSUS Pain Management System DEVICE

An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.

SENSUS Pain Management System; SENSUS Pain Management System - Sham

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women (non pregnant) 18 years old or above
• Diagnosed for Diabetes Mellitus (type 2)\* and ADA criteria Diabetes
• Evidence of peripheral neuropathy on neurologic examination
• Identified by our clinical staff examination and based on the criteria explained in -ADA statement
• Agreed to participate in this study and comply with instruction

You may not qualify if:

• Amputation and active ulcers or infection
• Cognitive deficits
• MMSE score of 24 or lower
• Unable to stand for more than 5 minutes (including symptomatic orthostatic hypotension or pain)
• Any clinically significant orthopedic, muscular, or peripheral vascular disorders that affect balance
• Alcohol or substance abuse within 6 months or major psychiatric disorder

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (6)

• Wrobel JS, Najafi B. Diabetic foot biomechanics and gait dysfunction. J Diabetes Sci Technol. 2010 Jul 1;4(4):833-45. doi: 10.1177/193229681000400411.

  PMID: 20663446 BACKGROUND

• Thakral G, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA. Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy. J Diabetes Sci Technol. 2013 Sep 1;7(5):1202-9. doi: 10.1177/193229681300700510.

  PMID: 24124947 BACKGROUND

• Najafi B, Crews RT, Wrobel JS. A novel plantar stimulation technology for improving protective sensation and postural control in patients with diabetic peripheral neuropathy: a double-blinded, randomized study. Gerontology. 2013;59(5):473-80. doi: 10.1159/000352072. Epub 2013 Jul 16.

  PMID: 23860103 BACKGROUND

• Aminian K, Najafi B, Bula C, Leyvraz PF, Robert P. Spatio-temporal parameters of gait measured by an ambulatory system using miniature gyroscopes. J Biomech. 2002 May;35(5):689-99. doi: 10.1016/s0021-9290(02)00008-8.

  PMID: 11955509 BACKGROUND

• Najafi B, Aminian K, Loew F, Blanc Y, Robert PA. Measurement of stand-sit and sit-stand transitions using a miniature gyroscope and its application in fall risk evaluation in the elderly. IEEE Trans Biomed Eng. 2002 Aug;49(8):843-51. doi: 10.1109/TBME.2002.800763.

  PMID: 12148823 BACKGROUND

• Najafi B, Horn D, Marclay S, Crews RT, Wu S, Wrobel JS. Assessing postural control and postural control strategy in diabetes patients using innovative and wearable technology. J Diabetes Sci Technol. 2010 Jul 1;4(4):780-91. doi: 10.1177/193229681000400403.

  PMID: 20663438 RESULT

Results Point of Contact

• Title: Lawrence Lavery, DPM, MPH
• Organization: UT Southwestern Medical Center at Dallas

Larry.Lavery@UTSouthwestern.edu

214-645-0544

Study Officials

• Lawrence A Lavery, DPM, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: January 13, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 14, 2020
• Results First Posted: August 14, 2020

Record last verified: 2020-07

Locations

US (1)