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Effect of Vestibular Perceptual Learning on Vestibular Thresholds and Balance

Studies

Study First Submitted Date 2023-03-17
Study First Posted Date 2023-04-19
Last Update Posted Date 2023-06-08
Start Month Year June 1, 2024
Primary Completion Month Year December 31, 2025
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-08

Detailed Descriptions

Sequence: 20566393
Description Four training paradigms will be evaluated in 4 cohorts of older 10 adults (N=40; Ages 60 to 89). The first training protocol will be a roll tilt training protocol previously shown to reduce roll tilt thresholds. The remaining three training protocols will include the parameters (i.e., plane of tilt, feedback schema, and difficulty level) found most effective following a series of basic science human subject experiments. As such, each cohort will perform perceptual training using a combination of the following training parameters: Tilt Plane: training stimuli will either be in (A) the roll plane, (B) the pitch plane, (C) in the anatomical plane of vertical semi-circular canals (i.e., 45 degrees between the roll and pitch planes). Difficulty Level: As was done in a published study of roll tilt perceptual training, the training stimuli will be adjusted during each training session using an adaptive staircase procedure. Older adults will train using either 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), (B) 3-Down/1-Up, or (C) 6-Down/1-Up staircase. The respective staircases target a stimulus that, on average, should yield an accuracy level of 70.7%, 79.4%, and 89.1%, and thus represent a progressive decrease in difficulty level. 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 one of three feedback schema: (A) an auditory stimulus indicating when an answer is correct, as well as incorrect, (B) a visual stimulus provided after the subject responds (i.e., chooses left or right) during the return of the chair to an upright position (i.e., tilting back to the start), or (C) a combination of auditory feedback and visual feedback. Specifically, one cohort of older adults will use the training protocol that, after completion of pilot experiments, is found to most effectively reduce tilt thresholds in young adults, another cohort will use the training protocol that yields the best change in balance in young adults, and the last cohort will use the remaining training protocol judged to best reduce thresholds AND yield the best sway changes. A training protocol may be repeated in more than one older adult cohort (e.g., if best threshold and best balance change are achieved via the same protocol in young adults) however each older adult participant recruited will only be randomly assigned to a single test condition. All other elements of the training not outlined above, (e.g., 6 days for testing/training visits, etc.) will mimic the published protocol. 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). Intervention-First arm: Day 1: Pre-test assessment Days 2-5: Active perceptual learning intervention Day 6: Post-test assessment Day 13: One-week retention assessment Day 36: One-month retention assessment Days 37-40: Control intervention Day 41: Post-test assessment Control-First arm: Day 1: Pre-test assessment Days 2-5: Control intervention Day 6: Post-test / Pre-Test assessment Days 7 to 10: Active perceptual learning intervention Day 11: Post-test assessment Day 18: One-week retention assessment Day 41: One-month retention assessment

Facilities

Sequence: 198562790
Name The Ohio State University Wexner Medical Center
City Columbus
State Ohio
Zip 43212
Country United States

Facility Investigators

Sequence: 18223826
Facility Id 198562790
Role Principal Investigator
Name Daniel M Merfeld, PhD

Conditions

Sequence: 51771300
Name Healthy Aging
Downcase Name healthy aging

Id Information

Sequence: 39840820 Sequence: 39840821
Id Source org_study_id Id Source secondary_id
Id Value R01AG073113 Id Value 3R01AG073113-02S1
Id Type U.S. NIH Grant/Contract Id Type U.S. NIH Grant/Contract
Id Link https://reporter.nih.gov/quickSearch/R01AG073113 Id Link https://reporter.nih.gov/quickSearch/3R01AG073113-02S1

Countries

Sequence: 42238119
Name United States
Removed False

Design Groups

Sequence: 55189287 Sequence: 55189288 Sequence: 55189289 Sequence: 55189290 Sequence: 55189291 Sequence: 55189292 Sequence: 55189293 Sequence: 55189294
Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental Group Type Experimental
Title Training Protocol 1 – Intervention First Title Training Protocol 1 – Placebo First Title Training Protocol 2 – Intervention First Title Training Protocol 2 – Placebo First Title Training Protocol 3 – Intervention First Title Training Protocol 3 – Placebo First Title Training Protocol 4 – Intervention First Title Training Protocol 4 – Placebo First
Description 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. Description 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. Description 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. Description 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. Description 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. Description 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. Description 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. Description 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.

Interventions

Sequence: 52092864 Sequence: 52092865
Intervention Type Behavioral Intervention Type Behavioral
Name Vestibular Perceptual Learning Name Placebo Intervention
Description The participants will be tilted and asked to indicate their perceived direction of self-motion (e.g., left or right). Feedback will be provided to promote learning (i.e., improved perception of motion). Feedback will only be provided after the subject response, and thus vestibular (i.e., self-motion) perception is required to judge the direction of the tilt stimulus. After each trial, a 3 second period of rest will be given. Each day of training will include three blocks of one-hundred trials each. Testing will take place in the dark (except for aims where a visual cue is provided). Subjects will be seated on a motion platform with a 5-point harness and the head restrained. Noise cancelling earpieces (along with a white noise signal) will be used to reduce external noise. Subjects will always be asked to make a decision (e.g. left versus right) by pressing buttons with their left or right hands. If not certain, subjects are instructed to provide their best guess. Description The placebo (or control) task will consist of oculomotor exercises that the subject will complete at home (i.e., outside of the lab). The oculomotor exercises will include saccadic eye movements performed in the horizontal and vertical planes. All movements will be completed within a limited, comfortable range of motion with the head remaining stationary. As the control intervention will be performed with the head stationary and in a seated position, no change in self-motion perception or balance is expected to result from the control (i.e., placebo) task.

Keywords

Sequence: 79214355 Sequence: 79214356 Sequence: 79214357 Sequence: 79214358 Sequence: 79214359
Name Vestibular Name Perception Name Balance Name Falls Name Learning
Downcase Name vestibular Downcase Name perception Downcase Name balance Downcase Name falls Downcase Name learning

Design Outcomes

Sequence: 176082801 Sequence: 176082802 Sequence: 176082803 Sequence: 176082804 Sequence: 176082805
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Change in Vestibular Roll Tilt Perceptual Thresholds Measure Change in the Postural Sway During the Modified Romberg Balance Test Measure Change in Postural Sway during the Sensory Organization Test Measure Change in the Time to Failure During the Modified Romberg Balance Test Measure Change in Pass/Fail Performance on the Modified Romberg Balance Test
Time Frame Intervention First Group: Days 1, 6, 13, 36, 41; Placebo First Group: Days 1, 6, 11, 18, 41 Time Frame Intervention First Group: Days 1, 6, 13, 36, 41; Placebo First Group: Days 1, 6, 11, 18, 41 Time Frame Intervention First Group: Days 1, 6, 13, 36, 41; Placebo First Group: Days 1, 6, 11, 18, 41 Time Frame Intervention First Group: Days 1, 6, 13, 36, 41; Placebo First Group: Days 1, 6, 11, 18, 41 Time Frame Intervention First Group: Days 1, 6, 13, 36, 41; Placebo First Group: Days 1, 6, 11, 18, 41
Description Vestibular perceptual thresholds will be measured using forced-choice methodologies; such methods have been used extensively. Passive, whole body tilts will 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 the perceive 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. Noise cancelling headphones 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 60 dB sound pressure level (SPL). Motion stimuli will consist of single cycles of sinusoidal acceleration. using published methods. Description 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. Description 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 3 times, for 20 seconds each. The root mean square displacement of the center of pressure (CoP) will be calculated for each trial, using the median of 3 trials as the primary outcome. Description 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. Description 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.

Sponsors

Sequence: 47946416 Sequence: 47946417
Agency Class OTHER Agency Class NIH
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Ohio State University Name National Institute on Aging (NIA)

Overall Officials

Sequence: 29049997
Role Principal Investigator
Name Daniel M Merfeld, PhD
Affiliation Ohio State University

Central Contacts

Sequence: 11927949 Sequence: 11927950
Contact Type primary Contact Type backup
Name Daniel M Merfeld, PhD Name Andrew R Wagner, PT, DPT, PhD
Phone 614-485-9179 Phone 614-485-9179
Email merfeld.6@osu.edu Email andrew.wagner@osumc.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 67662051 Sequence: 67662052 Sequence: 67662053 Sequence: 67662054 Sequence: 67662055 Sequence: 67662056 Sequence: 67662057 Sequence: 67662058 Sequence: 67662059 Sequence: 67662060 Sequence: 67662061 Sequence: 67662062 Sequence: 67662063 Sequence: 67662064 Sequence: 67662065 Sequence: 67662066
Design Group Id 55189287 Design Group Id 55189288 Design Group Id 55189289 Design Group Id 55189290 Design Group Id 55189291 Design Group Id 55189292 Design Group Id 55189293 Design Group Id 55189294 Design Group Id 55189287 Design Group Id 55189288 Design Group Id 55189289 Design Group Id 55189290 Design Group Id 55189291 Design Group Id 55189292 Design Group Id 55189293 Design Group Id 55189294
Intervention Id 52092864 Intervention Id 52092864 Intervention Id 52092864 Intervention Id 52092864 Intervention Id 52092864 Intervention Id 52092864 Intervention Id 52092864 Intervention Id 52092864 Intervention Id 52092865 Intervention Id 52092865 Intervention Id 52092865 Intervention Id 52092865 Intervention Id 52092865 Intervention Id 52092865 Intervention Id 52092865 Intervention Id 52092865

Eligibilities

Sequence: 30530930
Gender All
Minimum Age 65 Years
Maximum Age 89 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria 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
Adult False
Child False
Older Adult True

Calculated Values

Sequence: 254108341
Number Of Facilities 1
Registered In Calendar Year 2023
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 65
Maximum Age Num 89
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30279494
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking Single
Masking Description Statistical analysis at the conclusion of the trial will be completed using de-identified data, masking the outcomes assessor from the identity and group assignment of each individual.
Intervention Model Description Four training paradigms will be evaluated in 4 cohorts of older 10 adults; each subject will complete only one training task. In addition to the active perceptual learning task, each subject will complete a control (i.e., placebo) intervention. Half of each cohort will begin with the perceptual learning protocol, and half will begin with the placebo; assignment will be randomized. One of the training protocols will be a roll tilt training protocol previously shown to reduce roll tilt thresholds. The remaining three training protocols will include the parameters found most effective following a series of basic science human subject experiments that will be completed prior to enrollment begins in the present clinical trial.
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26478877 Sequence: 26478878
Intervention Id 52092864 Intervention Id 52092864
Name Vestibular Perceptual Training Name Vestibular Perceptual Adaptation

Responsible Parties

Sequence: 28658437
Responsible Party Type Principal Investigator
Name Dan Merfeld
Title Professor
Affiliation Ohio State University

Study References

Sequence: 51666341
Pmid 35894439
Reference Type background
Citation Wagner AR, Kobel MJ, Tajino J, Merfeld DM. Improving self-motion perception and balance through roll tilt perceptual training. J Neurophysiol. 2022 Sep 1;128(3):619-633. doi: 10.1152/jn.00092.2022. Epub 2022 Jul 27.