N/A
N=28
Electrical Stimulation for Improving Balance in Diabetes
Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT02337218 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Balance Test (BalanSense Device) — 1.54; 1.72; 1.76; 1.94 degrees^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SENSUS Pain Management System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Balance Test (BalanSense Device) |
1.54; 1.72; 1.76; 1.94; 2.94; 2.79 | — |
| PRIMARY Peripheral Neuropathy Measured by Vibration Perception Threshold (VPT) Testing |
41; 40 | — |
| PRIMARY Gait Test (LegSys System) |
0.87; 0.82; 1.26; 1.35 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02337218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.