The Ohio State University Wexner Medical Center
Columbus, Ohio, 43212, United States
Location status: Recruiting
Location contact
Daniel M Merfeld, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05818787
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.
Interested in participating?
Request Info65 year–89 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43212, United States
Location status: Recruiting
Daniel M Merfeld, PhD
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Daniel M Merfeld, PhD
CONTACT
Shauntelle A Cannon, AuD
CONTACT
Ohio State University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04205279
Brain Diseases, Cardiovascular Diseases
Chicago, Illinois, United States
View Trial DetailsNCT07675200
Autophagy, Healthy Aging
Canfield, Ohio, United States
View Trial DetailsNCT07642869
Healthy Aging, Multivitamin and Mineral Supplementation
La Jolla, California, United States
View Trial DetailsNCT07623785
Brain Health, Cardiometabolic Health
Brookings, South Dakota, United States
View Trial Details