An interventional study of Roll Tilt Training and Translation Training in Healthy Aging, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 65 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Ohio State University · Not applicable, Interventional, and Basic science
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.
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:
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:
Control-First arm:
Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Roll Tilt Training · Behavioral: Placebo Control
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.
Behavioral: Roll Tilt Training · Behavioral: Placebo Control
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.
Behavioral: Translation Training · Behavioral: Placebo Control
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.
Behavioral: Translation Training · Behavioral: Placebo Control
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.
Behavioral: Both Tilt and Translation Training · Behavioral: Placebo Control
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.
Behavioral: Both Tilt and Translation Training · Behavioral: Placebo Control
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 three second period of rest will be given. Each day of training will include four 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. Insert earbuds (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.
The participants will be translated 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 responds, and thus vestibular (i.e., self-motion) perception is required to judge the direction of the translation stimulus. After each trial, a three second period of rest will be given. Each day of training will include four 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. Insert earbuds (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.
The participants will be equally tilted and translated 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 responds. After each trial, a three second period of rest will be given. Each day of training will include four blocks; 2 blocks of roll tilt and 2 blocks of translation - 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. Insert earbuds (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.
Participants will complete home-based exercises that are not associated with improving vestibular perception or balance (e.g. saccades, smooth pursuit). Participants will sit in a comfortable chair facing out into a living space. They will then find a stationary object to the right and to the left of themselves as well as above and below their line of sight. Without moving their heads, they will look back and forth and up and down between the objects. Participants will complete a total of 400 eye motions per day for six days.
Change in Vestibular Roll Tilt Perceptual Thresholds
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.
Time frame: Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45
Change in Vestibular Translation Perceptual Thresholds
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.
Time frame: Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45
Change in the Postural Sway During the Modified Romberg Balance Test
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.
Time frame: Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45
Change in Postural Sway during the Sensory Organization Test
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.
Time frame: Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45
Change in Postural Sway during Perturbed Balance
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.
Time frame: Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45
Change in the Time to Failure During the Modified Romberg Balance Test
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.
Time frame: Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45
Change in Pass/Fail Performance on the Modified Romberg Balance Test
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.
Time frame: Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45
Change in Gait
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.
Time frame: Intervention First Group: Days 1, 8, 15, 38, 45; Placebo First Group: Days 1, 8, 15, 22, 45
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ohio State University