Trial Outcomes & Findings for Electrical Stimulation for Improving Balance in Diabetes (NCT NCT02337218)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	SENSUS Pain Management System Electrical stimulation device worn on the leg delivering a dose of 50 volts. SENSUS Pain Management System: 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 - Sham Electrical stimulation device worn on the leg and programmed to deliver no stimulation. SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.
Overall Study STARTED	17	11
Overall Study COMPLETED	17	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SENSUS Pain Management System n=17 Participants Electrical stimulation device worn on the leg delivering a dose of 50 volts. SENSUS Pain Management System: 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 - Sham n=11 Participants Electrical stimulation device worn on the leg and programmed to deliver no stimulation. SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.	Total n=28 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 11 • n=17 Participants	64 years STANDARD_DEVIATION 10 • n=11 Participants	60 years STANDARD_DEVIATION 11 • n=28 Participants
Sex: Female, Male Female	5 Participants n=17 Participants	2 Participants n=11 Participants	7 Participants n=28 Participants
Sex: Female, Male Male	12 Participants n=17 Participants	9 Participants n=11 Participants	21 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Qatar	17 participants n=17 Participants	11 participants n=11 Participants	28 participants n=28 Participants

PRIMARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	SENSUS Pain Management System n=17 Participants Electrical stimulation device worn on the leg delivering a dose of 50 volts. SENSUS Pain Management System: 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 - Sham n=11 Participants Electrical stimulation device worn on the leg and programmed to deliver no stimulation. SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.
Balance Test (BalanSense Device) Ankle sway - eyes open	1.54 degrees^2 Standard Deviation 0.71	1.72 degrees^2 Standard Deviation 1.4
Balance Test (BalanSense Device) Hip sway - eyes open	1.76 degrees^2 Standard Deviation 0.93	1.94 degrees^2 Standard Deviation 1.45
Balance Test (BalanSense Device) Ankle sway - eyes closed	2.94 degrees^2 Standard Deviation 1.94	2.79 degrees^2 Standard Deviation 1.72
Balance Test (BalanSense Device) Hip sway - eyes closed	3.23 degrees^2 Standard Deviation 2.13	3.17 degrees^2 Standard Deviation 0.97

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Outcome measures
Measure	SENSUS Pain Management System n=17 Participants Electrical stimulation device worn on the leg delivering a dose of 50 volts. SENSUS Pain Management System: 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 - Sham n=11 Participants Electrical stimulation device worn on the leg and programmed to deliver no stimulation. SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.
Peripheral Neuropathy Measured by Vibration Perception Threshold (VPT) Testing	41 volts Standard Deviation 7	40 volts Standard Deviation 10

PRIMARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	SENSUS Pain Management System n=17 Participants Electrical stimulation device worn on the leg delivering a dose of 50 volts. SENSUS Pain Management System: 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 - Sham n=11 Participants Electrical stimulation device worn on the leg and programmed to deliver no stimulation. SENSUS Pain Management System: An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.
Gait Test (LegSys System) Stride velocity	0.87 meters per second Standard Deviation 0.22	0.82 meters per second Standard Deviation 0.21
Gait Test (LegSys System) Stride time	1.26 meters per second Standard Deviation 0.14	1.35 meters per second Standard Deviation 0.25

Adverse Events

SENSUS Pain Management System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SENSUS Pain Management System - Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lawrence Lavery, DPM, MPH

UT Southwestern Medical Center at Dallas

Phone: 214-645-0544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place