Effect of Vestibular Perceptual Learning on Vestibular Thresholds and Balance

Not Applicable

Recruiting

• Conditions: Healthy Aging

• Registration Number: NCT05818787
• Lead Sponsor: Ohio State University

Brief Summary

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 and/or translations, as well as balance, by providing feedback following passive tilts or translations of the body. The protocol lasts a total of \~45 days: Day 1 includes a pre-test assessment of perception and balance, as well as 100 repetitions of training, Days 2-7 each include 400 repetitions of training, and Day 6 includes only post-test assessments of perception and balance.

Detailed Description

Three training paradigms will be evaluated in 3 cohorts of older 10 adults (N=30; Ages 65 to 89). Motion for all three training paradigms will be provided by a 12" Moog 6DoF motion platform. The first training protocol will be a roll tilt training protocol previously shown to reduce roll tilt thresholds. The second training protocols will be an inter-aural translation training protocol. The third training protocol will include half roll tilt training and half inter-aural translation training. As such, each cohort will perform perceptual training using a combination of the following training parameters:

1. Tilt Training: Training stimuli will be either a roll tilt to the left or right.

2. Translation Training: Training stimuli will be either a translation to the left or right.

3. Both Tilt Training and Translation Training will include half roll tilt training and half inter-aural translation training.

4. Older adults will train using a (A) 2-Down/1-Up (i.e., the size of the tilt stimulus decreases after 2 consecutive correct responses and increases after each incorrect response),

5. Feedback Method: During training, the accuracy of perceptual judgement (e.g., recognizing a left vs. right tilt motion) will be provided to the subject using a combination of auditory feedback and visual feedback. Auditory feedback will inform the subject whether they were correct or incorrect; visual feedback will be provided by the return motion with eyes open and lights on.

The targeted dates for each assessment and intervention period are shown, however, to permit greater adherence to the study protocol, tests of retention will be accepted if they occur within 7 to 10 days after the post-test (for the one-week follow-up) or 30 to 40 days after the post-test (for the one-month follow-up).

1. Intervention-First arm:

1. Day 1: Pre-test assessment

2. Days 2-7: Active perceptual learning intervention

3. Day 8: Post-test assessment

4. Day 15: One-week retention assessment

5. Day 38: One-month retention assessment

6. Days 39-44: Control intervention

7. Day 45: Post-test assessment

2. Control-First arm:

1. Day 1: Pre-test assessment

2. Days 2-7: Control intervention

3. Day 8: Post-test / Pre-Test assessment

4. Days 9 to 14: Active perceptual learning intervention

5. Day 15: Post-test assessment

6. Day 22: One-week retention assessment

7. Day 45: One-month retention assessment

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Study Start: 2025-08-13
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-04
• Last Update Posted: 2025-09-11
• Primary Completion: 2026-12-31
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Must be able to stand
• No leg or foot amputations
• No lower limb braces
• Not currently feeling dizzy/lightheaded
• Not currently pregnant by self-report
• Weight <= 275 pounds

Exclusion Criteria

• Severe head trauma or traumatic brain injury
• Any vestibular disorder (e.g., Meniere's Disease, Vestibular Migraine, Unresolved benign paroxysmal positional vertigo (BPPV), Vestibular hypofunction, except that due to aging, PPPD) as assessed by a Vestibular OtoNeurologist and Neurotologist using clinical diagnostic tests described in proposal plus any additional clinical evaluations they identify
• History of seizures
• Neurologic illness or condition determined by an Otoneurologist known to impact vestibular or balance function(e.g., stroke, neurodegenerative disorders, demyelinating illness)
• Major psychiatric (e.g., panic disorder, psychosis, etc.) disorder
• Any of the following eye diseases or conditions: amblyopia (or "lazy eye") or history of amblyopia, diagnosis of age-related macular degeneration, retina dystrophy, glaucoma, cataracts, or any other eye condition that limits vision to worse than 20/40
• Recent (<6 months) orthopedic injuries of the lower extremities (e.g., plantar fasciitis, ankle, knee or hip injury, back strain/herniated disc, …).
• Upper extremity injuries requiring current sling immobilization
• Recent surgery
• Any other severe health problem (heart disease, pulmonary disease, cancer, etc.).
• Vision in both eyes must be better than 20/40 with best correction
• 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
• Since every possible exclusionary factor cannot be predicted, additional exclusion criteria may be required

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Vestibular Roll Tilt Perceptual Thresholds	Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45	Vestibular perceptual thresholds will be measured using forced-choice methodologies; such methods have been used extensively. Passive, whole body tilts will be delivered using a Moog motion platform. Subjects will be tilted in one of two directions (e.g., towards the left or right) in complete darkness and asked to report their perceived direction of motion. All subjects will be seated in a chair with a 5-point harness. The head will be restrained by a standard motorcycle helmet. Insert earbuds will be worn, reducing external noise by about 20 decibels (dB). To mask potential auditory directionality cues, auditory "noise" - uncorrelated with motion (amplitude, direction, or type) - will be applied at 65 dB sound pressure level (SPL). Motion stimuli will consist of single cycles of sinusoidal acceleration using published methods.
Change in Vestibular Translation Perceptual Thresholds	Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45	Vestibular perceptual thresholds will be measured using forced-choice methodologies; such methods have been used extensively. Passive, whole body inter-aural translations will be delivered using a Moog motion platform. Subjects will be translated in one of two directions (e.g., towards the left or right) in complete darkness and asked to report their perceived direction of motion. All subjects will be seated in a chair with a 5-point harness. The head will be restrained by a standard motorcycle helmet. Insert earbuds will be worn, reducing external noise by about 20 decibel (dB); to mask potential auditory directionality cues, auditory "noise" - uncorrelated with motion (amplitude, direction, or type) - will be applied at 65 dB sound pressure level (SPL). Motion stimuli will consist of single cycles of sinusoidal acceleration using published methods.
Change in the Postural Sway During the Modified Romberg Balance Test	Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45	Static stance will be measured using a tri-axial force plate; postural sway will be measured in response to balance challenges including: (1) standing either on a foam or firm surface, (2) with the eyes either open or closed, and (3) with the feet together or in tandem. The center of pressure (COP) root-mean-square-distance will serve as the primary outcome measure describing postural sway.
Change in Postural Sway during the Sensory Organization Test	Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45	The Sensory Organization Test (SOT) is a standard clinical and research assessment used to quantify quiet stance postural sway in the presence of unreliable visual and proprioceptive feedback. The conditions of the test include (1) eyes open firm surface, 2) eyes closed firm surface, 3) sway referenced vision firm surface, 4) eyes open sway referenced platform, 5) eyes closed sway referenced platform, 6) sway referenced visual surround and platform. Sway-referencing describes a technique used to alter the reliability of proprioceptive and/or visual inputs by tilting the support surface or visual surround to follow the displacement of the CoP. Center of pressure data will be collected in each condition using a tri-axial force plate; each condition will be repeated three times, for 20 seconds each. The root mean square displacement (RMSD) of the CoP will be calculated for each trial, using the median of three trials as the primary outcome.
Change in Postural Sway during Perturbed Balance	Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45	Our perturbed balance test is a research assessment that we have developed to quantify postural sway in response to motion perturbations of the support surface. Vision will always be occluded (e.g., blindfolded). Forces and torques at the support surface will be quantified. Each trial will take about four minutes to complete and will be repeated three times. The root mean square displacement (RMSD) of the center of pressure (CoP) will be calculated for each trial, as will the gain at each perturbation frequency, using the median of three trials as the outcome variable.

Secondary Outcome Measures

Name	Time	Method
Change in the Time to Failure During the Modified Romberg Balance Test	Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45	Static stance will be measured using a tri-axial force plate; postural sway will be measured in response to balance challenges including: (1) standing either on a foam or firm surface, (2) with the eyes either open or closed, and (3) with the feet together or in tandem. If a trial cannot be completed due to a loss of balance, the time at which the loss of balance occurs will be recorded for each condition.
Change in Pass/Fail Performance on the Modified Romberg Balance Test	Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45	Static stance will be measured using a tri-axial force plate; postural sway will be measured in response to balance challenges including: (1) standing either on a foam or firm surface, (2) with the eyes either open or closed, and (3) with the feet together or in tandem. The ability to complete the test (i.e., without a loss of balance) will be recorded.
Change in Gait	Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45	Inertial measurement units (IMUs) will be used to collect motion data to quantify spatiotemporal characteristics of gait (i.e. gait velocity, single/double support time, step length, step width, stride length). Participants will wear noise-cancelling headphones that also provide 65 dB SPL of broadband, auditory noise to remove the contributions of environmental auditory feedback. Each participant will walk at a self-selected pace along a straight 117-foot path. They will make an 180° turn at each end and continue to walk for 6 minutes. IMUs will be placed on each ankle, the lumbar spine, neck, and head. The IMUs on the ankles will be used to detect heel-strike and toe-off, so that a custom MATLAB script will quantify the means and variability of each spatiotemporal characteristic of interest. Measurements will include both means and standard deviations of each parameter.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States