Balance Improvement Intervention for Vestibular Hypofunction

(MINDGAPS Trial)

Overseen By Brian J Loyd, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Montana

Disqualifiers: Cervical spine disorders, blindness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment, the Novel Intervention System, designed to help older adults improve balance and reduce dizziness. The focus is on individuals with vestibular hypofunction, a condition affecting the inner ear that can cause balance issues. Researchers seek to determine if this new system is effective and safe. Individuals who frequently experience dizziness or unsteadiness and can stand independently might be suitable candidates for this study. As an unphased trial, participants can contribute to groundbreaking research that could enhance balance and reduce dizziness for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this novel intervention system is safe for improving vestibular function?

Research shows that treatments for balance issues, such as the new system being tested, are generally safe and easy to manage. For example, studies on similar treatments using a balance test have shown good results without major safety concerns.

Other research on digital health tools for balance problems has found that these systems are easy to use and don't cause significant side effects. This suggests they are safe for improving balance and reducing dizziness. Although the new system remains in early testing, these findings suggest it might be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Novel Intervention System for vestibular hypofunction because it offers a fresh approach compared to traditional treatments like vestibular rehabilitation exercises. Most treatments focus on retraining the balance system through repetitive exercises. However, this new system potentially enhances the brain's ability to adapt and compensate for vestibular deficits more effectively. By incorporating advanced technology or novel therapeutic techniques, it might provide quicker or more sustained improvements in balance, making it a promising alternative for those struggling with balance issues.

What evidence suggests that this novel intervention system is effective for improving balance in vestibular hypofunction?

Research has shown that vestibular rehabilitation therapy (VRT) can help people with vestibular hypofunction improve balance and reduce symptoms. This therapy aids in balance, daily activities, and overall recovery. Studies also indicate that digital health tools can alter symptom perception and enhance management. One study found that similar tools improved balance and reduced dizziness in both adults and children. These findings suggest that the new intervention system tested in this trial could effectively help people with vestibular hypofunction improve balance and reduce dizziness. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults who can stand on their own and have dizziness or balance problems due to vestibular hypofunction, confirmed by specific tests. It's not for those with blindness, neck spine disorders, certain artery issues, or eye movement problems caused by central nervous system dysfunction.

Inclusion Criteria

Presence of peripheral vestibular hypofunction as indicated by examination with video nystagmography, video head impulse testing, or dynamic visual acuity testing.

I can stand up on my own.

I experience dizziness or problems with balance.

Exclusion Criteria

History of blindness

I have had paralysis affecting my eye movement.

I have had a vertebral or carotid artery dissection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo baseline assessments to establish control measures before intervention

2 weeks

Treatment

Participants complete 6 weeks of individualized vestibular rehabilitation informed by the MINDGAPS system

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Novel Intervention System

Trial Overview The study is testing a new intervention designed to improve vestibular function and reduce dizziness in older adults living in the community. The research will evaluate how well it works, its safety and feasibility, and whether people are likely to use it regularly.

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials

29

Recruited

4,700+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A randomized controlled trial with 42 patients showed that a 4-week customized exercise program significantly improved symptoms, disability, balance, and postural stability in individuals with chronic unilateral vestibular dysfunction.

In contrast, the control group that did not receive any treatment showed no significant improvements, highlighting the efficacy of vestibular rehabilitation exercises in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction: a randomized controlled study. Giray, M., Kirazli, Y., Karapolat, H., et al.[2022]

In a study involving 81 patients with chronic unilateral vestibular hypofunction, a combined exercise protocol (adaptation and habituation exercises) led to significantly better improvements in balance and self-perceived disability compared to single-exercise protocols after 8 weeks.

The combined exercise group showed faster improvements in functional gait and dynamic postural stability, indicating that a multi-faceted approach to vestibular rehabilitation may be more effective than focusing on just one type of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Vestibular Rehabilitation Modalities in Unilateral Vestibular Hypofunction: A Prospective Study. Lilios, A., Chimona, T., Papadakis, C., et al.[2023]

Vestibular physical therapy significantly improved balance and functional outcomes in 48 patients with central vestibular dysfunction, as shown by various assessment measures after an average of 5 therapy visits over 5 months.

Patients with severe disability at baseline experienced greater improvements, although those with cerebellar dysfunction showed the least progress, indicating that the type of vestibular dysfunction may influence therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for central vestibular dysfunction. Brown, KE., Whitney, SL., Marchetti, GF., et al.[2007]

In a study involving 9 patients with bilateral vestibular loss (BVL) and 9 control subjects, the use of an audio-biofeedback (ABF) system significantly improved balance stability in patients with BVL.

Participants with BVL showed a 23% reduction in sway area and a 46% decrease in trunk accelerations while using ABF, indicating enhanced postural control and stability during balance tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audio-biofeedback improves balance in patients with bilateral vestibular loss. Dozza, M., Chiari, L., Horak, FB.[2022]

Vestibular rehabilitation significantly reduces fall risk in individuals with unilateral vestibular hypofunction, as shown by a study of 47 patients aged 28 to 86, with a p-value of less than 0.001 indicating strong statistical significance.

Both older and younger adults benefited from the rehabilitation, but older adults (45% at risk at discharge) had a higher remaining fall risk compared to younger adults (11% at risk), highlighting the need for tailored interventions for different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of fall risk reduction as measured by dynamic gait index in individuals with unilateral vestibular hypofunction. Hall, CD., Schubert, MC., Herdman, SJ.[2019]

A study of 70 patients over 50 years old showed that vestibular rehabilitation therapy significantly improved balance, as measured by the Berg balance test, with scores increasing from 36.8 to 46.4 after therapy.

The therapy effectively reduces fall risk in at-risk elderly patients, demonstrating its importance as a preventive measure, with improvements observed immediately at the end of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of vestibular rehabilitation therapy in reducing falls. Macias, JD., Massingale, S., Gerkin, RD.[2022]

A study involving 29 participants with chronic vestibular dysfunction found that training with incrementally increasing surface tilt perturbations significantly improved gait and daily activities compared to traditional vestibular rehabilitation exercises alone.

Both the tilt perturbation training groups (P and P+EX) showed a reduced fall risk, with 8 out of 9 individuals improving their Dynamic Gait Index scores, indicating enhanced stability and safety during movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platform tilt perturbation as an intervention for people with chronic vestibular dysfunction. Winkler, PA., Esses, B.[2011]

Supervised vestibular rehabilitation treatment programs generally show better outcomes in improving emotional status, dizziness, and balance in individuals with unilateral vestibular disorders, based on a systematic review of six randomized control trials.

However, the review did not find strong evidence that supervised programs are significantly superior to unsupervised or home-based training, highlighting limitations in the self-reported measures used in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. Lilios, A., Chimona, T., Nikitas, C., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8920012/

Vestibular Rehabilitation for Peripheral Vestibular Hypofunction For the majority of individuals, VPT results in improved balance, reduced symptom complaints, improved functional recovery including activities of daily living, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9001890/

Toward a Digital Health Intervention for Vestibular ... Outcomes included the system usability scale, the patient enablement instrument (PEI), change in subjective symptoms (numerical rating scales), ...

3. scholars.uky.edu scholars.uky.edu/en/projects/improving-psychological-and-vestibular-health-using-a-novel-inter/

Improving Psychological and Vestibular Health Using a Novel ... This study is designed to examine the preliminary efficacy of the MINDGAPS system, along with the feasibility, safety, and acceptability of its use in practice.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05741515?term=AREA%5BConditionSearch%5D(%22Vestibulocochlear%20Nerve%20Diseases%22)&rank=1

Vestibular Balance Therapy Intervention for Children (VBT-C) Participants will receive a comprehensive battery of vestibular function and balance tests, then an 8-week home-based intervention to be done 5 times/week with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S019607092500078X

Enhanced recovery in unilateral vestibular hypofunction Previous research has shown that VRT positively affects the recovery of patients with UVH [8], and it improves subjective symptoms, gait performance, balance, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379862/

Vestibular Rehabilitation Using Dynamic Posturography CDP‐assisted interventions for unilateral vestibular deficits have been studied before, 36 , 37 and the reported outcomes have been positive; however, the ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK572153/

Vestibular Rehabilitation - StatPearls - NCBI Bookshelf - NIH Type, dose, and outcomes of physical therapy interventions for unilateral peripheral vestibular hypofunction: protocol for a systematic review. Hoppes CW, Anson ...

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.836796/full

Toward a Digital Health Intervention for Vestibular ... Outcomes included the system usability scale, the patient enablement instrument (PEI), change in subjective symptoms (numerical rating scales), ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06856746

Smartphone-based Utility of the Vestibulo-ocular Reflex | ... The goal of this observational study is to evaluate whether a novel smartphone-based (mHealth) application can accurately assess gaze stability and ...