Vestibular Training for Balance Improvement

Overseen By Andrew R Wagner, PT, DPT, PhD

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The intervention being studied is a minimal risk perceptual learning protocol delivered in an academic laboratory setting; the goal of the intervention is to improve the perception of passive whole-body tilts, as well as balance, by providing feedback during passive tilts of the body. The protocol lasts a total of 6 days: Day 1 includes a pre-test assessment of perception and balance, as well as 100 repetitions of training, Days 2-5 each include 300 repetitions of training, and Day 6 includes only post-test assessments of perception and balance.

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 data supports the effectiveness of the treatment Vestibular Perceptual Learning for balance improvement?

Research shows that vestibular perceptual learning, which involves training to improve the sense of motion, can significantly enhance balance by reducing postural sway. This suggests that such training can help improve balance in people with vestibular issues. ^{1 2 3 4 5}

Is vestibular training for balance improvement safe for humans?

The research on vestibular perceptual training, which involves exercises to improve balance, suggests it is safe for humans. No adverse effects were reported in studies where participants underwent training to improve their balance and self-motion perception. ^{2 3 6 7 8}

How does the Vestibular Perceptual Learning treatment improve balance compared to other treatments?

Vestibular Perceptual Learning is unique because it focuses on improving balance by training the brain to better perceive motion through specific exercises, rather than relying on medication or physical aids. This approach enhances the brain's ability to process vestibular (balance-related) information, which can lead to significant improvements in balance and reduction in postural sway with just a few hours of training. ^{3 6 9 10 11}

Research Team

Daniel M Merfeld, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

Not currently pregnant by self-report

No lower limb braces

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.

I have had seizures in the past.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Training Protocol 4 - Placebo First Experimental Treatment 2 Interventions

Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively reduce tilt thresholds AND improve balance in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, 3D/1U, or 6D/1U staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.

Group II: Training Protocol 4 - Intervention First Experimental Treatment 2 Interventions

Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively reduce tilt thresholds AND improve balance in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, 3D/1U, or 6D/1U staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The training protocol will be completed first, followed by the placebo intervention.

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

Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively improve balance in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, 3D/1U, or 6D/1U staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.

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

Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively improve balance in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, three-down, one-up (3D/1U), or six-down, one-up (6D/1U) staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The training protocol will be completed first, followed by the placebo intervention.

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

Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively reduce tilt thresholds in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, left anterior/right posterior (LARP) tilt, or right anterior/left posterior (RALP) tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, 3D/1U, or 6D/1U staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.

Group VI: Training Protocol 2 - Intervention First Experimental Treatment 2 Interventions

Participants will complete the training protocol that, after completion of preliminary basic science experiments, is found to most effectively reduce tilt thresholds in young adults. The potential training stimulus parameters are as follows: (1) roll tilt, pitch tilt, LARP tilt, or RALP tilt motion, (2) stimulus size will be adjusted based upon subject responses using either a 2D/1U, three-down, one-up (3D/1U), or six-down, one-up (6D/1U) staircase, and (3) either auditory, visual, or combined auditory+visual feedback will be provided. The training protocol will be completed first, followed by the placebo intervention.

Group VII: 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 only auditory feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.

Group VIII: Training Protocol 1 - 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: 0.5 Hz roll tilt motion, stimulus size will be adjusted based upon subject responses using a 2-down, 1-up (2D/1U) staircase, and only auditory feedback will be provided.The training protocol will be completed first, followed by the placebo 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+

Findings from Research

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 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]

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]

References

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

Comparison of Incremental Vestibulo-ocular Reflex Adaptation Training Versus x1 Training in Patients With Chronic Peripheral Vestibular Hypofunction: A Two-Year Randomized Controlled Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Positive verbal suggestion optimizes postural control. [2021]

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

Improving self-motion perception and balance through roll tilt perceptual training. [2023]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Short-term retention effect of rehabilitation using head position-based electrotactile feedback to the tongue: influence of vestibular loss and old-age. [2022]

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

Influence of Visual Feedback on Roll Tilt Perceptual Training. [2023]

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

Galvanic vestibular stimulation improves the results of vestibular rehabilitation. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of augmenting traditional rehabilitation with audio biofeedback in people with persistent imbalance following mild traumatic brain injury. [2022]

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

Learning to balance on one leg: motor strategy and sensory weighting. [2022]

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

Roll tilt self-motion direction discrimination training: First evidence for perceptual learning. [2020]

11. Brazil pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation with visual stimuli in peripheral vestibular disorders. [2022]