Visual Perturbations for Balance Disorder

Overseen By Ethan T Swierski, B.S.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Florida

Disqualifiers: Cognitive disorder, Musculoskeletal injury, Neurological injury, Low vision, others

Compensation: Varies

Number of Visits: 2

540 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether short, controlled interruptions in vision (intermittent visual perturbations) can improve balance during training sessions. Participants will practice walking on a low balance beam while special goggles alter their vision to assess enhancements in stability and movement. The trial compares various lengths and types of vision changes to determine the most effective approach. It suits individuals who can walk independently for 10 minutes and are open to trying different visual settings during balance exercises. As an Early Phase 1 trial, this research focuses on understanding how these visual changes affect balance, offering participants the opportunity to be among the first to explore this innovative approach.

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 intermittent visual perturbations are safe for balance training?

Research has shown that the visual techniques used in this trial have been studied before. One study found that participants who experienced these visual interruptions significantly improved their balance, reducing their missteps by an average of 78%. This suggests the technique can be effective for balance training.

Although extensive safety data on these visual techniques is not yet available, they are currently being tested in an early phase clinical trial. Researchers are assessing how well participants tolerate the treatment and monitoring for any side effects.

Overall, the available data suggest these visual techniques are generally well-tolerated. However, as the research is still in its early stages, some safety aspects may remain unknown. Participants should feel free to ask the research team any questions about potential risks or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Visual Perturbations for Balance Disorder trial because it explores a novel approach to improving balance through intermittent visual disruptions, a method not typically used in standard treatments. The trial utilizes specialized goggles to alter visual input, introducing periods of vision and occlusion, which may train the brain to enhance balance control more effectively. This technique has the potential to offer a non-invasive, drug-free alternative to traditional therapies like physical therapy or medications, by directly impacting the way the brain processes visual information related to balance.

What evidence suggests that this trial's treatments could be effective for balance disorders?

This trial will evaluate the effects of intermittent visual perturbations on balance. Participants in various treatment arms will experience different visual conditions while practicing balance beam walking. Research has shown that briefly blocking and restoring vision can significantly enhance balance training. In one study, participants who used these visual breaks improved their balance by 78% and had fewer missteps during exercises. Another study found that these visual changes can make balance training four times more effective and lead to longer-lasting results. This technique helps the body adjust better to balance tasks. Overall, early findings suggest that these visual disruptions can powerfully enhance balance. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with balance disorders. Participants will need to attend two lab sessions, the first lasting up to 3 hours and a follow-up after two weeks lasting up to 1 hour. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am willing to be assigned to any study group and follow all study procedures.

I can walk by myself for 10 minutes without stopping.

Exclusion Criteria

I have a recent leg injury that hurts when I walk or limits my walking.

I have a cognitive disorder that affects my daily independence.

I have a history of neurological issues like stroke or MS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training and Testing

Participants undergo balance training and testing with intermittent visual perturbations using goggles. The first session includes a pre-test, 30 minutes of training, and a post-test.

1 day

1 visit (in-person)

Follow-up Testing

Participants return for a post-test to assess retention of balance training improvements.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for balance changes between the initial training and follow-up sessions.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Visual Perturbations

Trial Overview The study tests whether wearing visual occlusion goggles while walking on a low-height balance beam can improve balance training outcomes. It measures body movement, muscle activity, and performance on the beam.

How Is the Trial Designed?

Group I: Intervention - Vision for 7.5s and Occlusion for 3s Experimental Treatment 2 Interventions

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 3s for the duration of the practice time.

Group II: Intervention - Vision for 7.5s and Occlusion for 1.5s Experimental Treatment 2 Interventions

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time.

Group III: Intervention - Vision for 7.5s and Occlusion for 0.75s Experimental Treatment 2 Interventions

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 0.75s for the duration of the practice time.

Group IV: Intervention - Vision for 3.75s and Occlusion for 1.5s Experimental Treatment 2 Interventions

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 3.75s, and the occlusion time will be set to 1.5s for the duration of the practice time.

Group V: Intervention - Vision for 15s and Occlusion for 1.5s Experimental Treatment 2 Interventions

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 15s, and the occlusion time will be set to 1.5s for the duration of the practice time.

Group VI: Intervention - Low Visible Light Transmission Experimental Treatment 2 Interventions

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. The visible light transmission will be set to a low value around 20% instead of total blackout for the occlusion time.

Group VII: Intervention - High Visible Light Transmission Experimental Treatment 2 Interventions

Participants will complete the balance beam walking practice while wearing the goggles. Vision time will be set to 7.5s, and the occlusion time will be set to 1.5s for the duration of the practice time. The visible light transmission will be set to a high value around 90% instead of total blackout for the occlusion time.

Group VIII: Intervention - Goggles Worn But Turned Off Experimental Treatment 2 Interventions

Participants will complete the balance beam walking practice while wearing the goggles, but they will not be turned on.

Group IX: Control - No Goggles Placebo Group 2 Interventions

Participants will complete the balance beam walking practice without any changes to vision.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

This study utilized a novel virtual reality system to investigate how different amplitudes and velocities of visual perturbations affect human body sway, revealing that increased visual input amplitude leads to greater hip displacement in balance.

The findings indicate that the optimal visual input velocity for maintaining balance is around 5 degrees per second, as this velocity produced the highest gain in body sway response, enhancing our understanding of how visual information is processed for postural control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of human balance control responses to visual inputs using virtual reality. Mohebbi, A., Amiri, P., Kearney, RE.[2022]

People with multiple sclerosis (PwMS) showed greater variability in trunk sway when exposed to anterior-posterior optical flow perturbations compared to matched controls, indicating they are more affected by these types of balance challenges.

The study suggests that optical flow perturbations could be a useful tool for screening balance deficits in PwMS, as both types of perturbations increased variability in balance, but the anterior-posterior perturbations had a more pronounced effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Optical Flow Perturbations on Standing Balance in People With Multiple Sclerosis. Elie, OS., Franz, JR., Selgrade, BP.[2023]

The chapter highlights the importance of multisensory integration, particularly the interaction between visual and vestibular systems, in maintaining balance, which is crucial for understanding balance disorders.

It discusses how visual motion can influence postural control and the rehabilitation strategies for patients with visual vertigo, emphasizing the use of repeated exposure to visual stimuli to alleviate symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multisensory integration in balance control. Bronstein, AM.[2022]

The novel virtual reality head stability test (VR_HST) effectively detected significant differences in postural sway and head oscillations between 17 patients with vestibular dysfunction and 16 control participants, indicating its potential as a sensitive assessment tool.

Patients exhibited larger head oscillations, particularly in pitch, yaw, and roll, during balance tasks, suggesting that the VR_HST could help tailor individualized treatment strategies for those with vestibular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A virtual reality head stability test for patients with vestibular dysfunction. Lubetzky, AV., Hujsak, BD.[2019]

Chronic patients with bilateral vestibular hypofunction (BVH) showed significantly worse posture stability in total darkness compared to healthy controls, indicating their reliance on visual input for balance.

BVH patients improved their posture stability when using visual targets and eye movements, suggesting they depend more on these signals than healthy individuals to maintain balance, especially in challenging conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Eye Movements Stabilize Posture in Patients With Bilateral Vestibular Hypofunction. Lacour, M., Dosso, NY., Heuschen, S., et al.[2020]

In a study involving 24 Parkinson's patients and 19 control volunteers, it was found that changes in visual information significantly affected balance in Parkinson's patients, highlighting their vulnerability to visual stimuli.

Unlike the control group, Parkinson's patients showed notable differences in their postural control when exposed to static versus moving visual fields, indicating the need for tailored assessment and rehabilitation strategies for balance disorders in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance in Parkinson's disease patients changing the visual input. Suarez, H., Geisinger, D., Ferreira, ED., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9083907/

Intermittent Visual Occlusions Increase Balance Training ... The group with intermittent visual occlusions substantially reduced their step-offs (post) and had an improvement in balance by 78% (Standard Deviation ± 26%).

2. trialx.com trialx.com/clinical-trials/listings/309656/intermittent-visual-perturbations-to-enhance-balance-training/

Intermittent Visual Perturbations to Enhance Balance ... Overview. The purpose of this research study is to determine if intermittent visual perturbations can improve balance training.

3. withpower.com withpower.com/trial/visual-perturbations-for-balance-disorder-326ab

Visual Perturbations for Balance Disorder The purpose of this research study is to determine if intermittent visual perturbations can improve balance training. The investigators will quantify ...

4. app.dimensions.ai app.dimensions.ai/details/grant/grant.7519576

"Intermittent Visual Perturbations to Enhance Balance ... Inclusion of intermittent visual occlusions in a balance training task can improve outcomes by four-fold and lead to longer lasting balance improvement.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12567797/

A Home-Based Balance Exercise Training Program with ... The present study assessed the feasibility, acceptability, and preliminary outcomes of balance training with intermittent visual deprivation ...

6. mdpi.com mdpi.com/1660-4601/18/10/5364

Short-Term Effects of Balance Training with Stroboscopic ... The current study provides preliminary and short-term findings to demonstrate that CAI patients may benefit from a visually challenging rehabilitation ...