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NCT02337218 · ClinicalTrials.gov registry record · NA
Electrical Stimulation for Improving Balance in Diabetes
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT02337218: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT02337218 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02337218, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE SENSUS Pain Management System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-11 |
| Est. Completion | 2017-03 |
| Phase | NA |
What the finished NCT02337218 record still lists
NCT02337218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which SENSUS Pain Management System is the first listed.
NCT02337218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02337218 about?
NCT02337218 is a clinical study titled "Electrical Stimulation for Improving Balance in Diabetes". 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...
What is the current status of trial NCT02337218?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2014-11. Estimated completion is 2017-03.
What interventions are being tested in trial NCT02337218?
The interventions under investigation include: SENSUS Pain Management System (DEVICE).
Who is sponsoring clinical trial NCT02337218?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02337218's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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