About this trial
The goal of this intervention study is to determine if a new electronic stimulation device, similar to a TENS can improve balance and make walking easier in older individuals with reduced balance function. The main question aims to answer the following:
Can using the device improve walking speed in older individuals?
Participants will be asked to perform a number of tasks while wearing the device:
Walk for 6 minutes
* Stand in place while having balance measured (eyes open and closed) * Stand on a foam block while having balance measured (eyes open and closed) * Sit in a chair that will tilt +/- 20 degrees while wearing goggles that take videos of the participants eyes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
impaired proprioception
significant eye problems
neuromuscular disease
seizure
Trial design
Crossover
Treatments tested in this trial
Subperceptual Stimulus
DeviceFor each test participants will be stimulated using a subperceptual electric signal that is optimized to improve their gait.
Sham Comparator
DeviceDuring intervention trial, sham comparator will consist of same stimulation device but no actual electrical stimulation will be provided by device during intervention trial.
Treatment groups
Trial outcomes
Primary outcomes
Gait velocity
Gait will be measured with a set of motion sensors (Xsens MTw Awinda motion sensors). These wearable inertial monitors measure rotational rate, acceleration, magnetic field strength, and temperature. The sensors are about the size of a watch and attach with Velcro bands. The sensors are wirelessly synchronized with each other and the software, eliminating interconnecting cables and minimizing risk of falling. Gait measures will include gait velocity, gait variability, gait synchronization.
Secondary outcomes
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Previous work has demonstrated that posturography provides significant information on vestibular function in the elderly. The mCTSIB will be performed as outlined in the Neurocom geriatric balance assessment to provide an effective initial screening tool. This test involves the subjects standing quietly on a force plate while center of mass and sway are measured with eyes open and closed. To create some instability, subjects will stand quietly on a foam block placed on the force plate with eyes open and then closed. Subjects with poor vestibular function should demonstrate significantly greater sway on tests in which their eyes are closed.
Ocular Torsion
OCR is a reflexive torsional eye movement response to a head tilt that has been attributed to the otoliths. It has been demonstrated that OCR is reduced in patients who lack otolithic inputs. Eye movements during OCR tests will be recorded with a videography system that uses the polar cross-correlation technique to measure ocular counter roll using gray scale information of iris patterns obtained from circular sampling paths at fixed radii from the pupil center. To assess otolithic function, binocular counter roll will be recorded with head upright, and then during passive tilting in a chair to the right and left. During the clinical OCR testing portion, the participant will be roll tilted \~30 degrees (whole body) and the eye is measured in roll for both position and velocity.
Video Head Impulse Testing (vHIT)
Subject will be fitted with lightweight goggles on which a small camera is mounted. The subject is asked to look at a target while the experimenter gives abrupt horizonal head rotations through a small angle to both the left and the right. The head movement speed is measured by the sensor in the goggles, and the image of the eye is captured by the high-speed camera and processed by very fast software to yield eye velocity. This is a standard clinical vestibular test.
Instrumental Timed Up and Go Test (TUG)
Subject will first sit with back against the chair and arms on the armrests. When instructed "Go", the subject will stand up, walk to a marker that is 3 meters away from the chair with their own comfortable and usual speed, and walk back, then sit back down to the chair. Time is taken from the "Go" command until the subject sit back down. This is a standard clinical test for mobility and functional ability with lower times indicate better mobility and lower fall risk.
Sponsors and contacts
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Massachusetts Eye and Ear Infirmary
Lead sponsor
University of Western Sydney
Collaborator
National Institute on Aging (NIA)
Collaborator
Johns Hopkins University
Collaborator