Vestibular Training for Balance Improvement

Overseen By Shauntelle A Cannon, AuD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Vestibular disorder, Seizures, Neurologic illness, Major psychiatric, Eye diseases, others

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

Compensation: Varies

Number of Visits: 8

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new training method designed to improve balance and enhance the ability to sense body tilting or movement. Participants will engage in exercises that provide feedback on body movements, aiming to enhance balance over a 45-day period. Individuals who can stand, do not use lower limb braces, and are not currently experiencing dizziness or lightheadedness may be suitable for this study.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could advance balance training methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this perceptual learning protocol is safe for improving balance?

Research has shown that vestibular perceptual learning is generally safe for people. Studies have found that this training can significantly improve balance and movement perception without causing serious side effects. In one study, participants improved their ability to sense body movements by 33.7%, particularly in side-to-side movements, with no negative effects reported. Another study found that less than 5 hours of training enhanced balance and posture, again with no negative effects reported. Overall, this suggests that the training is well-tolerated and poses minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on vestibular perceptual learning for improving balance because it explores a unique approach to enhancing balance through specific training protocols. Unlike standard balance therapies that might focus on physical exercises or medication, these protocols use targeted sensory feedback to adjust how our brain perceives motion. The trial examines different combinations of motion training, such as roll tilt and inter-aural translation, to see how each method impacts balance improvement. By providing auditory and visual feedback, these training methods could potentially offer a more engaging and effective way to reduce balance issues. Researchers hope to find out whether these innovative techniques can lead to significant improvements in balance more effectively than traditional methods.

What evidence suggests that this trial's protocols could be effective for improving balance?

Research has shown that training the vestibular system, which aids in balance and movement awareness, can significantly enhance these abilities. In this trial, participants will undergo various vestibular training protocols, such as roll tilt and inter-aural translation, to evaluate their effectiveness. Previous studies have demonstrated that participants who practiced balance exercises for just a few hours stood more steadily and noticed smaller movements. Another study found that this training not only improved balance but also enhanced posture and walking, with benefits observed after less than five hours of practice. In a different study, participants' ability to detect movement improved by 33% after six days of training. This evidence suggests that vestibular training, as tested in this trial, could effectively enhance balance and movement awareness. ^{2 6 7 8 9}

Who Is on the Research Team?

Daniel M Merfeld, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for healthy adults who can stand without assistance, have no leg or foot amputations, no lower limb braces, are not dizzy/lightheaded, not pregnant, and weigh under 275 pounds. It excludes those with vestibular disorders (except age-related), neurologic conditions affecting balance, recent surgeries or severe injuries to the upper body or eyes.

Inclusion Criteria

No lower limb braces

Not currently pregnant by self-report

I can stand up on my own.

Exclusion Criteria

Major psychiatric (e.g., panic disorder, psychosis, etc.) disorder

I have an eye condition like 'lazy eye', macular degeneration, or glaucoma that affects my vision to worse than 20/40.

Due to the potential for nausea with some of the motion stimuli, and to protect fetus and mother, pregnant women will also be excluded from this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-test Assessment

Day 1 includes a pre-test assessment of perception and balance

1 day

1 visit (in-person)

Active Perceptual Learning Intervention

Days 2-5 each include 300 repetitions of training to improve perception of passive whole-body tilts and balance

4 days

4 visits (in-person)

Post-test Assessment

Day 6 includes post-test assessments of perception and balance

1 day

1 visit (in-person)

One-week Retention Assessment

Assessment of retention of training effects one week after post-test

1 day

1 visit (in-person)

One-month Retention Assessment

Assessment of retention of training effects one month after post-test

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Intervention
• Vestibular Perceptual Learning

Trial Overview The study tests a perceptual learning protocol aimed at improving balance by training participants' perception of their body's tilts. Over six days, they undergo pre-tests, multiple training repetitions using feedback during passive body tilts and post-tests to assess changes in perception and balance.

How Is the Trial Designed?

Group I: Training Protocol 3 - Placebo First Experimental Treatment 2 Interventions

Participants will complete a training protocol that includes half roll tilt and half inter-aural translation. The training stimulus parameters are as follows: 0.5 Hz inter-aural translation motion and 0.5 Hz roll tilt, stimulus size will be adjusted based upon subject responses using 2D/1U staircases, and auditory and visual feedback will be provided. The placebo intervention will be completed first, followed by the training intervention.

Group II: Training Protocol 3 - Mixed Intervention First Experimental Treatment 2 Interventions

Participants will complete a training protocol that includes half roll tilt and half inter-aural translation. The training stimulus parameters are as follows: 0.5 Hz inter-aural translation motion and 0.5Hz roll tilt, stimulus size will be adjusted based upon subject responses using 2-down, 1-up (2D/1U) staircases, and both auditory and visual feedback will be provided. The training protocol will be completed first, followed by the placebo intervention.

Group III: Training Protocol 2 - Y-Translation Intervention First Experimental Treatment 2 Interventions

Participants will complete an inter-aural translation training protocol. The training stimulus parameters are as follows: 0.5 Hz inter-aural translation motion, stimulus size will be adjusted based upon subject responses using a 2-down, 1-up (2D/1U) staircase, and both auditory and visual feedback will be provided.The training protocol will be completed first, followed by the placebo intervention.

Group IV: Training Protocol 2 - Placebo First Experimental Treatment 2 Interventions

Participants will complete an inter-aural training protocol. The training stimulus parameters are as follows: 0.5 Hz inter-aural translation motion, stimulus size will be adjusted based upon subject responses using a 2D/1U staircase, and auditory and visual feedback will be provided. The placebo intervention will be completed first, followed by the training intervention.

Group V: Training Protocol 1 - Roll-Tilt Intervention First Experimental Treatment 2 Interventions

Participants will complete a roll tilt training protocol previously shown to reduce roll tilt thresholds. The training stimulus parameters are as follows: stimulus size for 0.5 Hz roll tilt motion will be adjusted based upon subject responses using a 2-down, 1-up (2D/1U) staircase, and both auditory and visual feedback will be provided.The training protocol will be completed first, followed by the placebo intervention.

Group VI: Training Protocol 1 - Placebo First Experimental Treatment 2 Interventions

Participants will complete a roll tilt training protocol previously shown to reduce roll tilt thresholds. The training stimulus parameters are as follows: 0.5 Hz roll tilt motion, stimulus size will be adjusted based upon subject responses using a 2D/1U staircase, and both auditory and visual feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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 of 31 participants with chronic mild traumatic brain injury (mTBI), vestibular rehabilitation therapy significantly improved balance, with both groups showing medium effect-sized decreases in symptoms and large increases in balance scores after 6 weeks of treatment.

The group receiving auditory biofeedback (ABF) showed trends towards better outcomes in motor activation and reduced time delay compared to the group without ABF, suggesting that incorporating ABF may enhance rehabilitation effectiveness for balance control in mTBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of augmenting traditional rehabilitation with audio biofeedback in people with persistent imbalance following mild traumatic brain injury. Campbell, KR., Peterka, RJ., Fino, PC., et al.[2022]

In a study involving 20 healthy adults, adding visual feedback to auditory cues during roll tilt perceptual training resulted in varied outcomes, with some individuals showing improved vestibular perception while others experienced increased thresholds.

The training protocol, which included 1,300 trials over 5 days, demonstrated that while visual feedback can enhance perceptual precision for some, the overall results were inconsistent, indicating a need for further research to optimize training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Visual Feedback on Roll Tilt Perceptual Training. Wagner, AR., Merfeld, DM.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9448335/

Improving self-motion perception and balance through roll tilt ... Our data show that roll tilt perceptual thresholds and quiet stance postural sway can be significantly improved after less than 5 h of roll tilt perceptual ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11377758/

Vestibular perceptual learning improves self-motion ... In this study, we demonstrated that vestibular perceptual training can be used to lower perceptual thresholds, while improving posture and gait parameters. We ...

3. journals.physiology.org journals.physiology.org/doi/abs/10.1152/jn.00092.2022

Improving self-motion perception and balance through roll ... Our data show that roll tilt perceptual thresholds and quiet stance postural sway can be significantly improved after less than 5 h of roll tilt perceptual ...

4. researchgate.net researchgate.net/publication/362298986_Improving_self-motion_perception_and_balance_through_roll_tilt_perceptual_training

Improving self-motion perception and balance through roll ... These initial data suggest that roll tilt perception can be improved with less than 5 hours of training and that vestibular perceptual training may contribute ...

5. link.springer.com link.springer.com/article/10.3758/s13414-019-01967-2

Roll tilt self-motion direction discrimination training After 6 days of training (9 h, 1,800 trials), perceptual thresholds were reduced by 33% in the 0.2-Hz roll direction discrimination task. This ...

6. nature.com nature.com/articles/s42003-024-06802-5

Vestibular perceptual learning improves self-motion ... In fact, vestibular perceptual training led to a substantial improvement of perceptual thresholds by 33.7% for the inter-aural translation and ...

7. trialx.com trialx.com/clinical-trials/listings/323740/effect-of-vestibular-perceptual-learning-on-vestibular-thresholds-and-balance/

Effect of Vestibular Perceptual Learning on ... The first training protocol will be a roll tilt training protocol previously shown to reduce roll tilt thresholds. The second training protocols ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0966636223014339

Review Human vestibular perceptual thresholds This review provides an integrative synthesis of the vestibular perceptual thresholds reported in the literature.

9. researchgate.net researchgate.net/publication/378726494_Vestibular_perceptual_learning_improves_self-motion_perception_posture_and_gait_in_older_adults

(PDF) Vestibular perceptual learning improves self-motion ... Linear inter-aural and angular roll tilt vestibular thresholds improved with training (95\% credible interval for pre/post difference) ...