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

Trial Summary

What is the purpose of this trial?

The proposed research is relevant to vestibular science and the general public because age-related vestibular hypofunction is a major contributor to poor balance, falls, and other adverse health outcomes. In this investigation the investigators will: 1) assess the preliminary efficacy of a novel intervention system for improving vestibular function and dizziness in community-dwelling older adults, 2) assess the safety and feasibility of the this system, and 3) assess the acceptability and implementation potential of this system, prior to a large-scale, R01-level investigation.

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 data supports the effectiveness of the treatment Novel Intervention System for improving balance in patients with vestibular hypofunction?

Research shows that vestibular rehabilitation therapy, which is similar to the Novel Intervention System, can help reduce fall risk and improve balance in people with vestibular issues. This suggests that the Novel Intervention System might also be effective in improving balance for those with vestibular hypofunction. ^{1 2 3 4 5}

Is the Balance Improvement Intervention for Vestibular Hypofunction safe for humans?

The research articles focus on the effectiveness of vestibular rehabilitation and related interventions, but they do not provide specific safety data. However, these studies generally imply that such interventions are safe, as they are commonly used in clinical settings for balance improvement. ^{1 3 5 6 7}

How is the Balance Improvement Intervention for Vestibular Hypofunction treatment different from other treatments?

The Balance Improvement Intervention for Vestibular Hypofunction is unique because it likely involves a novel system that may include audio-biofeedback, which uses sound to help patients improve their balance, unlike traditional vestibular rehabilitation that focuses on physical exercises. ^{2 3 5 6 8}

Eligibility Criteria

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

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

Treatment Details

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of vestibular rehabilitation therapy in reducing falls. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Prediction of fall risk reduction as measured by dynamic gait index in individuals with unilateral vestibular hypofunction. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Physical therapy for central vestibular dysfunction. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Short-term effects of vestibular rehabilitation in patients with chronic unilateral vestibular dysfunction: a randomized controlled study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Audio-biofeedback improves balance in patients with bilateral vestibular loss. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Platform tilt perturbation as an intervention for people with chronic vestibular dysfunction. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

Different Vestibular Rehabilitation Modalities in Unilateral Vestibular Hypofunction: A Prospective Study. [2023]