Noisy Galvanic Vestibular Stimulation Combined With a Multisensory Balance Program in Older Adults With Moderate to High Fall Risk: Protocol for a Feasibility Study for a Randomized Controlled Trial

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Abstract

Background

Reduced mobility and falls are common among older adults. Balance retraining programs are effective in reducing falls and in improving balance and mobility. Noisy galvanic vestibular stimulation is a low-level electrical stimulation used to reduce the threshold for the firing of vestibular neurons via a mechanism of stochastic resonance.

Objective

This study aims to determine the feasibility of using noisy galvanic vestibular stimulation to augment a balance training program for older adults at risk of falls. We hypothesize that noisy galvanic vestibular stimulation will enhance the effects of balance retraining in older adults at risk of falls

Methods

In this 3-armed randomized controlled trial, community dwelling older adults at risk of falling will be randomly assigned to a noisy galvanic vestibular stimulation plus balance program (noisy galvanic vestibular stimulation group), sham plus balance program (sham group), or a no treatment group (control). Participants will attend the exercise group twice a week for 8 weeks with assessment of balance and gait pretreatment, posttreatment, and at 3 months postintervention. Primary outcome measures include postural sway, measured by center of pressure velocity, area and root mean square, and gait parameters such as speed, step width, step variability, and double support time. Spatial memory will also be measured using the triangle completion task and the 4 Mountains Test.

Results

Recruitment began in November 2020. Data collection and analysis are expected to be completed by December 2022.

Conclusions

This study will evaluate the feasibility of using noisy galvanic vestibular stimulation alongside balance retraining in older adults at risk of falls and will inform the design of a fully powered randomized controlled trial.

Trial Registration

New Zealand Clinical Trials Registry (ACTRN12620001172998); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379944

International Registered Report Identifier (IRRID)

DERR1-10.2196/32085

Related collections

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Measuring lower body strength is critical in evaluating the functional performance of older adults. The purpose of this study was to assess the test-retest reliability and the criterion-related and construct validity of a 30-s chair stand as a measure of lower body strength in adults over the age of 60 years. Seventy-six community-dwelling older adults (M age = 70.5 years) volunteered to participate in the study, which involved performing two 30-s chair-stand tests and two maximum leg-press tests, each conducted on separate days 2-5 days apart. Test-retest intraclass correlations of .84 for men and .92 for women, utilizing one-way analysis of variance procedures appropriate for a single trial, together with a nonsignificant change in scores from Day 1 testing to Day 2, indicate that the 30-s chair stand has good stability reliability. A moderately high correlation between chair-stand performance and maximum weight-adjusted leg-press performance for both men and women (r = .78 and .71, respectively) supports the criterion-related validity of the chair stand as a measure of lower body strength. Construct (or discriminant) validity of the chair stand was demonstrated by the test's ability to detect differences between various age and physical activity level groups. As expected, chair-stand performance decreased significantly across age groups in decades--from the 60s to the 70s to the 80s (p < .01) and was significantly lower for low-active participants than for high-active participants (p < .0001). It was concluded that the 30-s chair stand provides a reasonably reliable and valid indicator of lower body strength in generally active, community-dwelling older adults.

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To review the stochastic resonance phenomena observed in sensory systems and to describe how a random process ('noise') added to a subthreshold stimulus can enhance sensory information processing and perception. Nonlinear systems need a threshold, subthreshold information bearing stimulus and 'noise' for stochastic resonance phenomena to occur. These three ingredients are ubiquitous in nature and man-made systems, which accounts for the observation of stochastic resonance in fields and conditions ranging from physics and engineering to biology and medicine. The stochastic resonance paradigm is compatible with single-neuron models or synaptic and channels properties and applies to neuronal assemblies activated by sensory inputs and perceptual processes as well. Here we review a few of the landmark experiments (including psychophysics, electrophysiology, fMRI, human vision, hearing and tactile functions, animal behavior, single/multiunit activity recordings). Models and experiments show a peculiar consistency with known neuronal and brain physiology. A number of naturally occurring 'noise' sources in the brain (e.g. synaptic transmission, channel gating, ion concentrations, membrane conductance) possibly accounting for stochastic resonance phenomena are also reviewed. Evidence is given suggesting a possible role of stochastic resonance in brain function, including detection of weak signals, synchronization and coherence among neuronal assemblies, phase resetting, 'carrier' signals, animal avoidance and feeding behaviors. Stochastic resonance is a ubiquitous and conspicuous phenomenon compatible with neural models and theories of brain function. The available evidence suggests cautious interpretation, but justifies research and should encourage neuroscientists and clinical neurophysiologists to explore stochastic resonance in biology and medical science.

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Mary Tinetti, Chandrika Kumar (2010)

Falls are common health events that cause discomfort and disability for older adults and stress for caregivers. Using the case of an older man who has experienced multiple falls and a hip fracture, this article, which focuses on community-living older adults, addresses the consequences and etiology of falls; summarizes the evidence on predisposing factors and effective interventions; and discusses how to translate this evidence into patient care. Previous falls; strength, gait, and balance impairments; and medications are the strongest risk factors for falling. Effective single interventions include exercise and physical therapy, cataract surgery, and medication reduction. Evidence suggests that the most effective strategy for reducing the rate of falling in community-living older adults may be intervening on multiple risk factors. Vitamin D has the strongest clinical trial evidence of benefit for preventing fractures among older men at risk. Issues involved in incorporating these evidence-based fall prevention interventions into outpatient practice are discussed, as are the trade-offs inherent in managing older patients at risk of falling. While challenges and barriers exist, fall prevention strategies can be incorporated into clinical practice.

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Author and article information

Contributors

Denise Taylor:

ORCID: https://orcid.org/0000-0002-0955-5702

Rehabilitation Innovation CentreSchool of Clinical SciencesAuckland University of TechnologyAA115, AA Building90 Akoranga Drive, NorthcoteAuckland, 0627New Zealand64 9 9210 9680denise.taylor@aut.ac.nz

Journal

Journal ID (nlm-ta): JMIR Res Protoc

Journal ID (iso-abbrev): JMIR Res Protoc

Journal ID (publisher-id): ResProt

Title: JMIR Research Protocols

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Electronic): 1929-0748

Publication date Collection: October 2021

Publication date (Electronic): 5 October 2021

Volume: 10

Issue: 10

Electronic Location Identifier: e32085

Affiliations

[1 ] Rehabilitation Innovation Centre School of Clinical Sciences Auckland University of Technology Auckland New Zealand

[2 ] Department of Pharmacology and Toxicology School of Biomedical Sciences University of Otago Dunedin New Zealand

Author notes

Corresponding Author: Denise Taylor denise.taylor@ 123456aut.ac.nz

Author information

Ruth McLaren https://orcid.org/0000-0003-1803-6944

Paul F Smith https://orcid.org/0000-0003-1961-7118

Sue Lord https://orcid.org/0000-0002-6670-6191

Preet Kamal Kaur https://orcid.org/0000-0002-8781-3930

Yiwen Zheng https://orcid.org/0000-0002-2439-0715

Denise Taylor https://orcid.org/0000-0002-0955-5702

Article

Publisher ID: v10i10e32085

DOI: 10.2196/32085

PMC ID: 8527374

PubMed ID: 34609323

SO-VID: 4e63e75c-fa2b-4aaf-8dac-bb6049cbe818

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

History

Date received : 26 July 2021

Date revision requested : 4 August 2021

Date revision received : 10 August 2021

Date accepted : 10 August 2021

Custom metadata

ext-peer-rev This paper was peer reviewed by the Health Research Council of New Zealand. See the Multimedia Appendix for the peer-review report;

Keywords: older adult,balance,rehabilitation,noisy galvanic vestibular stimulation,ngvs,brain stimulation

Data availability:

Keywords: older adult, balance, rehabilitation, noisy galvanic vestibular stimulation, ngvs, brain stimulation

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